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BMC Endocrine Disorders
Published in: BMC Endocrine Disorders 1/2015

Open Access 01-12-2015 | Research article

Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis

Authors: Marcin Czech, Elżbieta Rdzanek, Justyna Pawęska, Olga Adamowicz-Sidor, Maciej Niewada, Michał Jakubczyk

Published in: BMC Endocrine Disorders | Issue 1/2015

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Abstract

Background

Diabetes mellitus (DM) leads to multiple complications, including severe hypoglycaemia events (SHEs). SHEs can impact a patient’s quality of life and compliance and may directly result in additional costs to the health care system. The aim of this review was to evaluate the risk of severe hypoglycaemia in patients with type 1 (T1) and 2 (T2) DM as observed in everyday clinical practice for various drug regimens.

Methods

We conducted a systematic review of observational (retrospective or prospective) studies in the MEDLINE, Embase, and Cochrane Library databases that covered at least 100 children or adults with T1/T2 DM. In T1 DM, basal-bolus/pre-mix insulin (human or analogue) and insulin pump were reviewed, and in T2 DM, basal-bolus/pre-mix insulin (human or analogue), oral antidiabetic drugs supported with basal insulin (human or analogue), sulfonylureas in monotherapy, and combined oral treatment were reviewed. In order to estimate SHE rates, we extracted data on the time horizon of the study, number of patients, number of SHEs, and number of patients experiencing at least one SHE. We used a random effects model to estimate the annual SHE rate. We considered the risk for other antidiabetic medications in T2 DM to be negligible and the results of our main review yielded no observational data for premixes in T1 DM so they were assessed based on relative rates taken from additional systematic reviews. The study, being a desk research, did not involve any human subjects (including human material or human data) and no ethical committee approval was asked for. For the same reason there was no need to collect informed consent for participation in the study.

Results

We identified 76 observational studies encompassing 707,722.30 patient-years. The estimated annual SHE rate varied from 0.168 (95 % CI 0.123–0.237) for insulin pump up to 1.628 for biphasic human insulin in T1 DM patients, and from 0.0035 for oral antidiabetic drugs up to 0.554 (95 % CI 0.157–7.534) for basal-bolus with human insulin in T2 DM patients.

Conclusions

Our review indicates that SHE rates differ between patients depending on treatment regimen. However, SHEs are also driven by other factors. Proper modelling techniques are needed to use various types of information in published studies.
Appendix
Available only for authorised users
Literature
1.
Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;16:1047–53.CrossRef
2.
UK Prospective Diabetes Study (UKPDS) Group. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837–53.CrossRef
3.
Diabetes Control and Complications Trial Research (DCCT) Group. The effect of intensive treatment in diabetes on the development and progression of long term complications in insulin dependent diabetes mellitus. N Engl J Med. 1993;329:977–86.CrossRef
4.
Whipple AO. The surgical therapy of hyperinsulinism. J Int Chir. 1938;3:237–76.
5.
Workgroup on Hypoglycemia, Workgroup on Hypoglycemia, American Diabetes Association. Defending and reporting hypoglycaemia in diabetes. Diabets Care. 2005;28:1245–9.CrossRef
6.
UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes; effects of treatment modalities and their duration. Diabetologia. 2007;50:1140–7.CrossRef
7.
Yki-Järvinen H, Ryysy L, Nikkilä K, Tulokas T, Vanamo R, Heikkilä M. Comparison of bedtime insulin regimens in patients with type 2 diabetes mellitus. A randomized, controlled trial. Ann Intern Med. 1999;130:389–96.PubMedCrossRef
8.
MacLeod KM, Hepburn DA, Frier BM. Frequency and morbidity of severe hypoglycaemia in insulin-treated diabetic patients. Diabet Med. 1993;10:238–45.PubMedCrossRef
9.
Jakubczyk M, Pawęska J, Niewada M, Rdzanek E, Czech M. Risk of severe hypoglycaemia for various treatment regimens – a systematic review and meta-analysis of observational studies. JHPOR. 2014; doi:10.​7365/​JHPOR.​2014.​2.​9
10.
Moher D, Liberati A, Tetzlaff J, Altman DG, the PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. PLoS Med. 2009;6:e1000097.PubMedCentralPubMedCrossRef
11.
Jönsson L, Bolinder B, Lundkvist J. Cost of hypoglycemia in patients with Type 2 diabetes in Sweden. Value Health. 2006;9:193–8.PubMedCrossRef
12.
Hammer M, Lammert M, Mejías SM, Kern W, Frier BM. Costs of managing severe hypoglycaemia in three European countries. J Med Econ. 2009;12:281–90.PubMedCrossRef
13.
Lammert M, Hammer M, Frier BM. Management of severe hypoglycaemia: cultural similarities, differences and resource consumption in three European countries. J Med Econ. 2009;12:269–80.PubMedCrossRef
14.
Orozco-Beltrán D, Mezquita-Raya P, Ramírez De Arellano A, Galán M. Self-reported frequency and impact of hypoglycaemic events in Spain. Diabetes Ther. 2014;5:155–68.PubMedCentralPubMedCrossRef
15.
Willis WD, Diago-Cabezudo JI, Madec-Hily A, Aslam A. Medical resource use, disturbance of daily life and burden of hypoglycaemia in insulin-treated patients with diabetes: results from a European online survey. Expert Rev Pharmacoecon Outcomes Res. 2013;13:123–30.PubMedCrossRef
16.
17.
Deeks JJ, Dinnes J, D’Amico R, Sowden AJ, Sakarovitch C, Song F, et al. Evaluating non-randomised intervention studies. Health Technol Assess. 2003;7:1–173. iii-x.CrossRef
18.
19.
Shamliyan T, Kane RL, Dickinson S. A systematic review of tools used to assess the quality of observational studies that examine incidence or prevalence and risk factors for diseases. J Clin Epidemiol. 2010;63:1061–70.PubMedCrossRef
20.
21.
Ali M, White J, Lee CH, Palmer JL, Smith-Palmer J, Fakhoury W, et al. Therapy conversion to biphasic insulin aspart 30 improves long-term outcomes and reduces the costs of type 2 diabetes in Saudi Arabia. J Med Econ. 2008;11:651–70.PubMedCrossRef
22.
Almustafa M, Yeo JP, Khutsoane D. Glycaemic control and hypoglycaemia in the PRESENT study. Diabetes Res Clin Pract. 2008;81 Suppl 1:S10–5.PubMedCrossRef
23.
Andayani TM, Ibrahim MIM, Asdie AH. The safety of triple therapy with oral antidiabetics versus insulin in type 2 diabetes. Asian J Pharm Clin Res. 2010;3:201–3.
24.
Aung PP, Strachan MW, Frier BM, Butcher I, Deary IJ, Price JF. Severe hypoglycaemia and late-life cognitive ability in older people with Type 2 diabetes: the Edinburgh Type 2 Diabetes Study. Diabet Med. 2012;29:328–36.PubMedCrossRef
25.
Berntorp K, Haglund M, Larsen S, Petruckevitch A, Landin-Olsson M. Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden. Prim Care Diabetes. 2011;5:89–94.PubMedCrossRef
26.
Biesenbach G, Bodlaj G, Pieringer H. Weight gain and metabolic control in newly insulin-treated patients with type 2 diabetes with different insulin regimens. Can J Diabetes. 2006;30:384–9.CrossRef
27.
Breum L, Almdal T, Eiken P, Lund P, Christiansen E. Initiating or switching to biphasic insulin aspart 30/70 therapy in subjects with type 2 diabetes mellitus. An observational study. Rev Diabet Stud. 2008;5:154–62.PubMedCentralPubMedCrossRef
28.
Brod M, Valensi P, Shaban JA, Bushnell DM, Christensen TL. Patient treatment satisfaction after switching to NovoMix® 30 (BIAsp 30) in the IMPROVE study: an analysis of the influence of prior and current treatment factors. Qual Life Res. 2010;19:1285–93.PubMedCentralPubMedCrossRef
29.
Bruttomesso D, Pianta A, Crazzolara D, Scaldaferri E, Lora L, Guarneri G, et al. Continuous subcutaneous insulin infusion (CSII) in the Veneto region: efficacy, acceptability and quality of life. Diabet Med. 2002;19:628–34.PubMedCrossRef
30.
de Bock M, Gunn AJ, Holt JA, Derraik JG, Reed P, Cutfield W, et al. Impact of insulin pumps on glycaemic control in a pump-naive paediatric regional population. J Paediatr Child Health. 2012;48:247–52.PubMedCrossRef
31.
Dornhorst A, Lüddeke HJ, Honka M, Ackermann RW, Meriläinen M, Gallwitz B, et al. Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-Week data from the European cohort of the PREDICTIVE study. Curr Med Res Opin. 2008;24:369–76.PubMedCrossRef
32.
Dornhorst A, Lüddeke HJ, Koenen C, Meriläinen M, King A, Robinson A, et al. Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal-only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14-week follow-up data from PREDICTIVE®. Diabetes Obes Metab. 2008;10:75–81.PubMed
33.
Dornhorst A, Lüddeke HJ, Sreenan S, Kozlovski P, Hansen JB, Looij BJ, et al. Insulin detemir improves glycaemic control without weight gain in insulin-naive patients with type 2 diabetes: Subgroup analysis from the PREDICTIVE® study. Int J Clin Pract. 2008;62:659–65.PubMedCrossRef
34.
Dornhorst A, Lüddeke HJ, Sreenan S, Koenen C, Hansen JB, Tsur A, et al. Safety and efficacy of insulin detemir in clinical practice: 14-Week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVETM European cohort. Int J Clin Pract. 2007;61:523–8.PubMedCrossRef
35.
Esteghamati A, Rajabian R, Amini M, Bahrami A, Khamseh ME, Afkhami-Ardekani M, et al. The safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in Iranians with type 2 diabetes: An open-label, non-randomised, multi-centre observational study - The Iran subgroup of the IMPROVE® study. Endokrynol Pol. 2010;61:364–70.PubMed
36.
Fontaine P, Gin H, Pinget M, Thivolet C, Hanaire H, Robert JJ, et al. Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE. Adv Ther. 2009;26:535–51.PubMedCrossRef
37.
Furlong NJ, McNulty SJ, O’Brien SV, Hardy KJ. Comparison of metformin versus sulphonylurea in combination with daily NPH insulin in patients with type 2 diabetes inadequately controlled on oral hypoglycaemic agents; median follow-up 29 months. Practical Diabetes Int. 2002;19:245–9.CrossRef
38.
Gao Y, Guo XH, Vaz JA. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: Chinese PRESENT study. Diabetes Obes Metab. 2009;11:33–40.PubMedCrossRef
39.
Gao Y, Guo XH. Switching from human insulin to biphasic insulin aspart 30 treatment gets more patients with type 2 diabetes to reach target glycosylated hemoglobin <7%: The results from the China cohort of the PRESENT study. Chin Med J (Engl). 2010;123:1107–11.
40.
Garber AJ, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study). Diabetes Obes Metab. 2006;8:58–66.PubMedCrossRef
41.
Garg SK, Gottlieb PA, Hisatomi ME, D’Souza A, Walker AJ, Izuora KE, et al. Improved glycemic control without an increase in severe hypoglycemic episodes in intensively treated patients with type 1 diabetes receiving morning, evening, or split dose insulin glargine. Diabetes Res Clin Pract. 2004;66:49–56.PubMedCrossRef
42.
Garg SK, Paul JM, Karsten JI, Menditto L, Gottlieb PA. Reduced severe hypoglycaemia with insulin glargine in intensively treated adults with type 1 diabetes. Diabetes Technol Ther. 2004;6:589–95.PubMedCrossRef
43.
Garg SK, Walker AJ, Hoff HK, D’Souza AO, Gottlieb PA, Chase HP. Glycemic parameters with multiple daily injections using insulin glargine versus insulin pump. Diabetes Technol Ther. 2004;6:9–15.PubMedCrossRef
44.
Giorda C, Boemi M, Borzì V, Chiaramonte F, Mattei P, Tribulato A. The IMPROVE study a multinational, multicentre, observational study in type 2 diabetes: results from the Italian cohort. Acta Biomed. 2010;81:115–24.PubMed
45.
Gu Y, Hou X, Zhang L, Pan J, Cai Q, Bao Y, et al. The impact of initiating biphasic human insulin 30 therapy in type 2 diabetes patients after failure of oral antidiabetes drugs. Diabetes Technol Ther. 2012;14:244–50.PubMedCentralPubMedCrossRef
46.
Güler S, Sharma SK, Almustafa M, Kim CH, Azar S, Danciulescu R, et al. Improved glycaemic control with biphasic insulin aspart 30 in type 2 diabetes patients failing oral antidiabetic Drugs: PRESENT study results. Arch Drug Inf. 2009;2:23–33.PubMedCentralPubMedCrossRef
47.
Gumprecht J, Benroubi M, Borzi V, Kawamori R, Shaban J, Shah S, et al. Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix® 30) can improve glycaemic control in patients treated with basal insulins: A subgroup analysis of the IMPROVE observational study. Int J Clin Pract. 2009;63:966–72.PubMedCentralPubMedCrossRef
48.
Gumprecht J, Zurawska G, Wolnik B, Dzida G. The IMPROVE study - A multinational, observational study in type 2 diabetes: Data from the Polish cohort. Endokrynol Pol. 2008;59:460–6.PubMed
49.
Hanefeld M, Fleischmann H, Landgraf W, Pistrosch F. EARLY study: Early basal insulin therapy under real-life conditions in type 2 diabetics. Diabetes Stoffwech H. 2012;21:91–7.
50.
Hartemann-Heurtier A, Sachon C, Masseboeuf N, Corset E, Grimaldi A. Functional intensified insulin therapy with short-acting insulin analog: effects on HbA1c and frequency of severe hypoglycaemia. An observational cohort study. Diabetes Metab. 2003;29:53–7.PubMedCrossRef
51.
Hassan MI, Aamir AH, Miyan Z, Siddiqui LA, Qureshi MS, Shaikh MZ. Safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes mellitus in the Pakistani population: Results from the A1chieve study. J Pak Med Assoc. 2012;62:929–36.PubMed
52.
Hermansen K, Dornhorst A, Sreenan S. Observational, open-label study of type 1 and type 2 diabetes patients switching from human insulin to insulin analogue basal-bolus regimens: insights from the PREDICTIVE study. Curr Med Res Opin. 2009;25:2601–8.PubMedCrossRef
53.
Hermansen K, Lund P, Clemmensen K, Breum L, Kleis Moller M, Mette Rosenfalck A, et al. 3-Month results from Denmark within the globally prospective and observational study to evaluate insulin detemir treatment in type 1 and type 2 diabetes: The PREDICTIVE study. Rev Diabet Stud. 2007;4:89–97.PubMedCentralPubMedCrossRef
54.
Herwig J, Scholl-Schilling G, Böhles H. Glycaemic control and hypoglycaemia in children, adolescents and young adults with unstable type 1 diabetes mellitus treated with insulin glargine or intermediate-acting insulin. J Pediatr Endocrinol Metab. 2007;20:517–25.PubMedCrossRef
55.
Home P, Naggar NE, Khamseh M, Gonzalez-Galvez G, Shen C, Chakkarwar P, et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract. 2011;94:352–63.PubMedCrossRef
56.
Honkasalo M, Elonheimo O, Sane T. Many diabetic patients with recurrent severe hypoglycaemias hold a valid driving license. A community-based study in insulin-treated patients with diabetes. Traffic Inj Prev. 2010;11:258–62.PubMedCrossRef
57.
Honkasalo MT, Elonheimo OM, Sane T. Severe hypoglycaemia in drug-treated diabetic patients needs attention: a population-based study. Scand J Prim Health Care. 2011;29:165–70.PubMedCentralPubMedCrossRef
58.
Ishii H, Iwase M, Seino H, Shuto Y, Atsumi Y. Assessment of quality of life in patients with type 2 diabetes mellitus before and after starting biphasic insulin aspart 30 (BIAsp 30) therapy: IMPROVE study in Japan. Curr Med Res Opin. 2011;27:643–50.PubMedCrossRef
59.
Iványi T, Fövényi J, Faludi P, Han J, Macconell L, Wille S, et al. Long-term effects of adding Exenatide to a regimen of metformin and/or sulfonylurea in type 2 diabetes: an uncontrolled, open-label trial in Hungary. Clin Ther. 2012;34:1301–13.PubMedCrossRef
60.
Jakisch BI, Wagner VM, Heidtmann B, Lepler R, Holterhus PM, Kapellen TM, et al. Comparison of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) in paediatric Type 1 diabetes: a multicentre matched-pair cohort analysis over 3 years. Diabet Med. 2008;25:80–5.PubMedCrossRef
61.
Jang HC, Guler S, Shestakova M. When glycaemic targets can no longer be achieved with basal insulin in type 2 diabetes, can simple intensification with a modern pre-mix insulin help? Results from a subanalysis of the PRESENT study. Int J Clin Pract. 2008;62:1013–8.PubMedCentralPubMedCrossRef
62.
Jang HC, Lee SR, Vaz JA. Biphasic insulin aspart 30 in the treatment of elderly patients with type 2 diabetes: A subgroup analysis of the PRESENT Korea NovoMixstudy. Diabetes Obes Metab. 2009;11:20–6.PubMedCrossRef
63.
Kapellen TM, Heidtmann B, Bachmann J, Ziegler R, Grabert M, Holl RW. Indications for insulin pump therapy in different age groups - An analysis of 1567 children and adolescents. Diabet Med. 2007;24:836–42.PubMedCrossRef
64.
Kapellen TM, Wolf J, Rosenbauer J, Stachow R, Ziegler R, Szczepanski R, et al. Changes in the use of analogue insulins in 37 206 children and adolescents with type 1 diabetes in 275 German and Austrian centres during the last twelve years. Exp Clin Endocrinol Diabetes. 2009;117:329–35.PubMedCrossRef
65.
Katz ML, Volkening LK, Anderson BJ, Laffel LM. Contemporary rates of severe hypoglycaemia in youth with Type1 diabetes: Variability by insulin regimen. Diabet Med. 2012;29:926–32.PubMedCentralPubMedCrossRef
66.
Kawamori R, Eliaschewitz FG, Takayama H, Hayashida CY. Efficacy of insulin glargine and glimepiride in controlling blood glucose of ethnic Japanese patients with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2008;79:97–102.PubMedCrossRef
67.
Kawamori R, Valensi P. IMPROVE observational study of biphasic insulin aspart 30/70 in patients with Type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2010;5:507–16.CrossRef
68.
Keen AJ, Duncan E, McKillop-Smith A, Evans ND, Gold AE. Dose Adjustment for Normal Eating (DAFNE) in routine clinical practice: who benefits? Diabet Med. 2012;29:670–6.PubMedCrossRef
69.
Khader S, Abdelfattah W, Almansari A, Elnnagar NK. Safety and efficacy of switching to biphasic insulin aspart 30/70 (BIAsp 30) under the routine diabetic care in patients with type 2 diabetes: The IMPROVE observational study in the Gulf region. Int J Diabetes Mellit. 2010;2:110–3.CrossRef
70.
Khutsoane D, Sharma SK, Almustafa M, Jang HC, Azar ST, Danciulescu R, et al. Biphasic insulin aspart 30 treatment improves glycaemic control in patients with type 2 diabetes in a clinical practice setting: experience from the PRESENT study. Diabetes Obes Metab. 2008;10:212–22.PubMedCrossRef
71.
Kristensen PL, Hansen LS, Jespersen MJ, Pedersen-Bjergaard U, Beck-Nielsen H, Christiansen JS, et al. Insulin analogues and severe hypoglycaemia in type 1 diabetes. Diabetes Res Clin Pract. 2012;96:17–23.PubMedCrossRef
72.
Kurtoglu S, Atabek ME, Dizdarer C, Pirgon O, Isguven P, Emek S. Insulin detemir improves glycemic control and reduces hypoglycaemia in children with type 1 diabetes: Findings from the Turkish cohort of the PREDICTIVE® observational study. Pediatr Diabetes. 2009;10:401–7.PubMedCrossRef
73.
Leckie AM, Graham MK, Grant JB, Ritchie PJ, Frier BM. Frequency, severity, and morbidity of hypoglycaemia occurring in the workplace in people with insulin-treated diabetes. Diabetes Care. 2005;28:1333–8.PubMedCrossRef
74.
Leinung M, Thompson S, Nardacci E. Benefits of continuous glucose monitor use in clinical practice. Endocr Pract. 2010;16:371–5.PubMedCrossRef
75.
Levit S, Toledano Y, Wainstein J. Improved glycaemic control with reduced hypoglycaemic episodes and without weight gain using long-term modern pre-mix insulins in type 2 diabetes. Int J Clin Pract. 2011;65:165–71.PubMedCrossRef
76.
Ligthelm RJ. Self-titration of biphasic insulin aspart 30/70 improves glycaemic control and allows easy intensification in a Dutch clinical practice. Prim Care Diabetes. 2009;3:97–102.PubMedCrossRef
77.
Lüddeke HJ, Sreenan S, Aczel S, Maxeiner S, Yenigun M, Kozlovski P, et al. PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab. 2007;9:428–34.PubMedCrossRef
78.
Mäkelä JK, Schmüser C, Askonen K, Saukkonen T. Starting or switching to biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes: a multicenter, observational, primary care study conducted in Finland. Diabetes Res Clin Pract. 2012;95:10–8.PubMedCrossRef
79.
Marre M, Pinget M, Gin H, Thivolet C, Hanaire H, Robert JJ, et al. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain: 52-week data from the PREDICTIVE study in a cohort of French patients with type 1 or type 2 diabetes. Diabetes Metab. 2009;35:469–75.PubMedCrossRef
80.
Meneghini LF, Dornhorst A, Sreenan S. Once-daily insulin detemir in a cohort of insulin-naive patients with type 2 diabetes: a sub-analysis from the PREDICTIVE study. Curr Med Res Opin. 2009;25:1029–35.PubMedCrossRef
81.
Meneghini LF, Rosenberg KH, Koenen C, Merilainen MJ, Lüddeke HJ. Insulin detemir improves glycaemic control with less hypoglycaemia and no weight gain in patients with type 2 diabetes who were insulin naive or treated with NPH or insulin glargine: clinical practice experience from a German subgroup of the PREDICTIVE study. Diabetes Obes Metab. 2007;9:418–27.PubMedCrossRef
82.
Müller-Godeffroy E, Treichel S, Wagner VM. Investigation of quality of life and family burden issues during insulin pump therapy in children with Type 1 diabetes mellitus --a large-scale multicentre pilot study. Diabet Med. 2009;26:493–501.PubMedCrossRef
83.
Nimri R, Weintrob N, Benzaquen H, Ofan R, Fayman G, Phillip M. Insulin pump therapy in youth with type 1 diabetes: a retrospective paired study. Pediatrics. 2006;117:2126–31.PubMedCrossRef
84.
Nobels F, D’Hooge D, Crenier L. Switching to biphasic insulin aspart 30/50/70 from biphasic human insulin 30/50 in patients with type 2 diabetes in normal clinical practice: Observational study results. Curr Med Res Opin. 2012;28:1017–26.PubMedCrossRef
85.
Oishi M, Abe N, Yokoyama H, Kuribayashi N, Tomonaga O, Matoba K, et al. Observational 6-month open-label study of Japanese type 2 diabetes patients switching from NPH insulin to insulin detemir in basal-bolus regimen: 23rd article of the Japan diabetes clinical data management study group (JDDM23). J Int Med Res. 2012;40:787–97.PubMedCrossRef
86.
Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, et al. Efficacy and tolerability of self-titrated biphasic insulin Aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post Hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011;33:874–83.PubMedCrossRef
87.
Peczyńska J, Urban M, Głowińska B, Florys B. Decreased consciousness of hypoglycaemia and the incidence of severe hypoglycaemia in children and adolescents with diabetes type 1. Endokrynol Diabetol Chor Przemiany Materii Wieku Rozw. 2002;8:77–82.PubMed
88.
Perriello G, Caputo S, De Pergola G, Di Carlo A, Grassi G, Lapolla A, et al. Improved glycemic control with weight loss and a low risk of hypoglycaemia with insulin detemir: insights from the Italian cohort of the PREDICTIVE study after 6-month observation in type 2 diabetic subjects. Expert Opin Pharmacother. 2011;12:2449–55.PubMedCrossRef
89.
Pettersson B, Rosenqvist U, Deleskog A, Journath G, Wändell P. Self-reported experience of hypoglycaemia among adults with type 2 diabetes mellitus (Exhype). Diabetes Res Clin Pract. 2011;92:19–25.PubMedCrossRef
90.
Preumont V, Buysschaert M, De Beukelaer S, Mathieu C. Insulin detemir in routine clinical practice: A 26-week follow-up in type 1 diabetic patients from the Belgian PREDICTIVE cohort. Acta Clin Belg. 2009;64:49–55.PubMedCrossRef
91.
Reda E, Von Reitzenstein A, Dunn P. Metabolic control with insulin pump therapy: the Waikato experience. N Z Med J. 2007;120:U2401.PubMed
92.
Rudolph JW, Hirsch IB. Assessment of therapy with continuous subcutaneous insulin infusion in an academic diabetes clinic. Endocr Pract. 2002;8:401–5.PubMedCrossRef
93.
Scaramuzza AE, Iafusco D, Rabbone I, Bonfanti R, Lombardo F, Schiaffini R, et al. Use of integrated real-time continuous glucose monitoring/insulin pump system in children and adolescents with type 1 diabetes: a 3-year follow-up study. Diabetes Technol Ther. 2011;13:99–103.PubMedCrossRef
94.
Scheidegger U, Allemann S, Scheidegger K, Diem P. Continuous subcutaneous insulin infusion therapy: effects on quality of life. Swiss Med Wkly. 2007;137:476–82.PubMed
95.
Shah S, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al. Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix® 30) when switching from human premix insulin in patients with type 2 diabetes: Subgroup analysis from the 6-month IMPROVE observational study. Int J Clin Pract. 2009;63:574–82.PubMedCentralPubMedCrossRef
96.
Shah S, Das AK, Kumar A, Unnikrishnan AG, Kalra S, Baruah MP, et al. Baseline characteristics of the Indian cohort from the IMPROVE study: a multinational, observational study of biphasic insulin aspart 30 treatment for type 2 diabetes. Adv Ther. 2009;26:325–35.PubMedCrossRef
97.
Shah S, Zilov A, Malek R, Soewondo P, Bech O, Litwak L. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: Results from the A1chieve observational study. Diabetes Res Clin Pract. 2011;94:364–70.PubMedCrossRef
98.
Shah SN, Litwak L, Haddad J, Chakkarwar PN, Hajjaji I. The A1chieve study: a 60 000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract. 2010;88 Suppl 1:S11–6.PubMedCrossRef
99.
Sharma SK, Al-Mustafa M, Oh SJ, Azar ST, Shestakova M, Guler S, et al. Biphasic insulin aspart 30 treatment in patients with type 2 diabetes poorly controlled on prior diabetes treatment: Results from the PRESENT study. Curr Med Res Opin. 2008;24:645–52.PubMedCrossRef
100.
Sharma SK, Joshi SR, Kumar A, Unnikrishnan AG, Hoskote SS, Moharana AK, et al. Efficacy, safety and acceptability of biphasic insulin aspart 30 in Indian patients with type 2 diabetes: results from the PRESENT study. J Assoc Physicians India. 2008;56:859–63.PubMed
101.
Shestakova M, Bech OM, Momani MS. Study design and baseline characteristics of patients in the PRESENT study. Diabetes Res Clin Pract. 2008;81 Suppl 1:S3–9.PubMedCrossRef
102.
Shestakova M, Sharma SK, Almustafa M, Min KW, Ayad N, Azar ST, et al. Transferring type 2 diabetes patients with uncontrolled glycaemia from biphasic human insulin to biphasic insulin aspart 30: experiences from the PRESENT study. Curr Med Res Opin. 2007;23:3209–14.PubMedCrossRef
103.
Sreenan S, Virkamaki A, Zhang K, Hansen JB. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: Data from the European cohort of the PREDICTIVE® study. Int J Clin Pract. 2008;62:1971–80.PubMedCrossRef
104.
Strojek K, Tarasiuk A, Bijos P, Czech A. Gensulin M30 in patients with type 2 diabetes and secondary failure to oral antidiabetic drugs. the Progens-first-step study: A multicentre observational study in the outpatient setting. Diabet Dośw i Klin. 2008;8:179–84.
105.
Sudhakaran C, Fathima M, Anjana RM, Unnikrishnan RI, Mohan V. Effectiveness of exenatide in Asian Indians in a clinical care setting. Diabetes Technol Ther. 2010;12:613–8.PubMedCrossRef
106.
Sudhakaran C, Kishore U, Anjana RM, Unnikrishnan R, Mohan V. Effectiveness of sitagliptin in asian Indian patients with type 2 diabetes-an Indian tertiary diabetes care center experience. Diabetes Technol Ther. 2011;13:27–32.PubMedCrossRef
107.
Suzuki D, Toyoda M, Kondo M, Miyatake H, Tanaka E, Sato H, et al. Efficacy of long-acting insulin analog insulin glargine at high dosage for basal-bolus insulin therapy in patients with type 2 diabetes. Tokai J Exp Clin Med. 2012;37:35–40.PubMed
108.
Temizel M, Mert M, Bozbey C, Arman Y, Cevizci E, Altintaş N, et al. Evaluation of the weight-increasing effects of biphasic analog and regular NPH insulin mixtures in patients with Type 2 diabetes mellitus. J Diabetes. 2010;2:250–5.PubMedCrossRef
109.
Tsai ST, Pathan F, Ji L, Yeung VT, Chadha M, Suastika K, et al. First insulinization with basal insulin in patients with Type 2 diabetes in a real-world setting in Asia. J Diabetes. 2011;3:208–16.PubMedCentralPubMedCrossRef
110.
Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al. Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix 30) in routine care: Safety and effectiveness in patients with type 2 diabetes in the IMPROVE observational study. Int J Clin Pract. 2009;63:522–31.PubMedCrossRef
111.
Valensi P, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al. The IMPROVE study-a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int J Clin Pract. 2008;62:1809–19.PubMedCrossRef
112.
Vergès B, Brun JM, Tawil C, Alexandre B, Kerlan V. Strategies for insulin initiation: insights from the French LIGHT observational study. Diabetes Metab Res Rev. 2012;28:97–105.PubMedCrossRef
113.
Vexiau P, Mavros P, Krishnarajah G, Lyu R, Yin D. Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in France. Diabetes Obes Metab. 2008;10 Suppl 1:16–24.PubMedCrossRef
114.
Wenying Y, Benroubi M, Borzi V, Gumprecht J, Kawamori R, Shaban J, et al. Improved glycaemic control with BIAsp 30 in insulin-naive type 2 diabetes patients inadequately controlled on oral antidiabetics: subgroup analysis from the IMPROVE study. Curr Med Res Opin. 2009;25:2643–54.PubMedCrossRef
115.
Wood JR, Moreland EC, Volkening LK, Svoren BM, Butler DA, Laffel LM. Durability of insulin pump use in pediatric patients with type 1 diabetes. Diabetes Care. 2006;29:2355–60.PubMedCrossRef
116.
Yang W, Gao Y, Liu G, Chen L, Fu Z, Zou D, et al. Biphasic insulin aspart 30 as insulin initiation or replacement therapy: the China cohort of the IMPROVE study. Curr Med Res Opin. 2010;26:101–7.PubMedCrossRef
117.
Yang W, Lv X, Li Q, Jia W, Tian H. A prospective study to optimize insulin treatment by switching to insulin glargine in type 2 diabetic patients previously uncontrolled on pre-mix insulin: the optimization study. Curr Med Res Opin. 2012;28:533–41.PubMedCrossRef
118.
Yenigun M, Honka M. Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the PREDICTIVE study. Int J Clin Pract. 2009;63:425–32.PubMedCrossRef
119.
Zick R, Petersen B, Richter M, Haug C. Comparison of continuous blood glucose measurement with conventional documentation of hypoglycaemia in patients with Type 2 diabetes on multiple daily insulin injection therapy. Diabetes Technol Ther. 2007;9:483–92.PubMedCrossRef
120.
Zjačic-Rotkvić V, Cigrovski-Berković M, Grulović N, Baršić B. Efficacy and safety of a basal-bolus regimen with insulin glargine in patients with type 2 diabetes after failing premix insulin therapy: A multicenter postmarketing study. Diabetol Croat. 2012;41:41–8.
121.
El Naggar NK, Soewondo P, Khamseh ME, Chen JW, Haddad J. Switching from biphasic human insulin 30 to biphasic insulin aspart 30 in type 2 diabetes is associated with improved glycaemic control and a positive safety profile: results from the A1chieve study. Diabetes Res Clin Pract. 2012;98:408–13.PubMedCrossRef
122.
El-Naggar N, Almansari A, Khudada K, Salman S, Mariswamy N, Abdelfattah W, et al. The A1 chieve study - an observational non-interventional study of patients with type 2 diabetes mellitus initiating or switched to insulin analogue therapy: subgroup analysis of the Gulf population. Int J Clin Pract. 2013;67:128–38.PubMedCrossRef
123.
Gómez-Peralta F, Carramiñana-Barrera F, Félix-Redondo FJ, Fraile-Gómez J. Glycaemic control in patients with type 2 diabetes switching from premixed insulin to long-acting basal insulin analogue plus oral antidiabetic drugs: an observational study. Int J Clin Pract. 2012;66:959–68.PubMedCrossRef
124.
Pīrāgs V, El Damassy H, Dąbrowski M, Gönen MS, Račická E, Martinka E, et al. Low risk of severe hypoglycaemia in patients with type 2 diabetes mellitus starting insulin therapy with premixed insulin analogues BID in outpatient settings. Int J Clin Pract. 2012;66:1033–41.CrossRef
125.
Khunti K, Caputo S, Damci T, Dzida GJ, Ji Q, Kaiser M, et al. The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries. Diabetes Obes Metab. 2012;14:1129–36.PubMedCrossRef
126.
Hendrieckx C, Halliday JA, Bowden JP, Colman PG, Cohen N, Jenkins A, et al. Severe hypoglycaemia and its association with psychological well-being in Australian adults with type 1 diabetes attending specialist tertiary clinics. Diabetes Res Clin Pract. 2014;103:430–6.PubMedCrossRef
127.
Nørgaard K, Scaramuzza A, Bratina N, Lalić NM, Jarosz-Chobot P, Kocsis G, et al. Routine sensor-augmented pump therapy in type 1 diabetes: the INTERPRET study. Diabetes Technol Ther. 2013;15:273–80.PubMedCentralPubMedCrossRef
128.
Laubner K, Molz K, Kerner W, Karges W, Lang W, Dapp A, et al. Daily insulin doses and injection frequencies of neutral protamine hagedorn (NPH) insulin, insulin detemir and insulin glargine in type 1 and type 2 diabetes: a multicenter analysis of 51 964 patients from the German/Austrian DPV-wiss database. Diabetes Metab Res Rev. 2014;30:395–404.PubMedCrossRef
129.
Levy-Shraga Y, Lerner-Geva L, Modan-Moses D, Graph-Barel C, Mazor-Aronovitch K, Boyko V, et al. Benefits of continuous subcutaneous insulin infusion (CSII) therapy in preschool children. Exp Clin Endocrinol Diabetes. 2013;121:225–9.PubMedCrossRef
130.
Maiorino MI, Bellastella G, Petrizzo M, Improta MR, Brancario C, Castaldo F, et al. Treatment satisfaction and glycemic control in young Type 1 diabetic patients in transition from pediatric health care: CSII versus MDI. Endocrine. 2014;46:256–62.PubMedCrossRef
131.
Maltoni G, Zucchini S, Scipione M, Rollo A, Balsamo C, Bertolini C, et al. Severe hypoglycemic episodes: a persistent threat for children with Type 1 diabetes mellitus and their families. J Endocrinol Invest. 2013;36:617–21.PubMed
132.
Ziegler R, Tubili C, Chico A, Guerci B, Lundberg E, Borchert M, et al. ProAct study: new features of insulin pumps improve diabetes management and glycemic control in patients after transition of continuous subcutaneous insulin infusion systems. Diabetes Technol Ther. 2013;15:738–43.PubMedCrossRef
133.
Carlsson A, Forsander G, Ludvigsson J, Larsen S, Ortqvist E. A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes. Pediatr Diabetes. 2013;14:358–65.PubMedCentralPubMedCrossRef
134.
Buturovic BA, Lekic A, Grulovic N. Improved glycaemic control with insulin glargine as part of a basal-bolus regimen in T2DM patients inadequately controlled on premixed therapy. Med Arch. 2013;67:342–5.PubMedCrossRef
135.
Echtay A, Tsur A, Hasan MI, Abu-Hijleh MO, Al Khatib N, Andari E, et al. Clinical experience with insulin detemir in patients with type 2 diabetes from the near East countries. Diabetes Ther. 2013;4:399–408.PubMedCentralPubMedCrossRef
136.
Guo XH, Lv XF, Han P, Zhang XZ, Yang HZ, Duan WR, et al. Efficacy and safety of glimepiride as initial treatment in Chinese patients with Type 2 diabetes mellitus. Curr Med Res Opin. 2013;29:169–74.PubMedCrossRef
137.
Klen J, Dolžan V, Janež A. CYP2C9, KCNJ11 and ABCC8 polymorphisms and the response to sulphonylurea treatment in type 2 diabetes patients. Eur J Clin Pharmacol. 2014;70:421–8.PubMedCrossRef
138.
Klen J, Goričar K, Janež A, Dolžan V. The role of genetic factors and kidney and liver function in glycemic control in type 2 diabetes patients on long-term metformin and sulphonylurea cotreatment. Biomed Res Int. 2014;2014:934729.PubMedCentralPubMedCrossRef
139.
Kulzer B, Seitz L, Kern W. Real-world patient-reported rates of non-severe hypoglycaemic events in Germany. Exp Clin Endocrinol Diabetes. 2014;122:167–72.PubMedCrossRef
140.
Nakashima E, Kuribayashi N, Ishida K, Taketsuna M, Takeuchi M, Imaoka T. Efficacy and safety of stepwise introduction of insulin lispro mix 50 in Japanese patients with type 2 diabetes inadequately controlled by oral therapy. Endocr J. 2013;60:763–72.PubMedCrossRef
141.
Kalra S, Deepak MC, Narang P, Singh V, Uvaraj MG, Agrawal N. Usage pattern, glycemic improvement, hypoglycemia, and body mass index changes with sulfonylureas in real-life clinical practice: results from OBSTACLE Hypoglycemia Study. Diabetes Technol Ther. 2013;15:129–35.PubMedCrossRef
142.
Kalra S, Deepak MC, Narang P, Singh V, Maheshwari A. Correlation between measures of hypoglycaemia and glycemic improvement in sulfonylurea treated patients with type 2 diabetes in India: Results from the OBSTACLE hypoglycaemia study. J Postgrad Med. 2014;60:151–5.PubMedCrossRef
143.
Östenson CG, Geelhoed-Duijvestijn P, Lahtela J, Weitgasser R, Markert Jensen M, Pedersen-Bjergaard U. Self-reported non-severe hypoglycaemic events in Europe. Diabet Med. 2014;31:92–101.PubMedCentralPubMedCrossRef
144.
Panelo AA, Dorado ED, Lelis M, Javelona JQ. A post-marketing surveillance study report to evaluate the safety and efficacy of a fixed-dose combination of glimepiride and metformin in the treatment of type 2 diabetes mellitus. Philipp J Intern Med. 2013;51:3.
145.
Lieverse AG, Rodriguez M, Czupryniak L, Landgraf W, Loizeau V, Pilorget V, et al. Glycaemic control of type 2 diabetics with insulin glargine in everyday practice. Diabetes Stoffwech H. 2013;22:141–7.
146.
Damci T, Emral R, Svendsen AL, Balkir T, Vora J. Lower risk of hypoglycaemia and greater odds for weight loss with initiation of insulin detemir compared with insulin glargine in Turkish patients with type 2 diabetes mellitus: local results of a multinational observational study. BMC Endocr Disord. 2014;14:61.PubMedCentralPubMedCrossRef
147.
Tentolouris N, Kyriazopoulou V, Makrigiannis D, Baroutsou B. Intensification of insulin therapy in patients with type 2 diabetes: a retrospective, non- interventional cohort study of patients treated with insulin glargine or biphasic human insulin in daily clinical practice. Diabetol Metab Syndr. 2013;5:4.CrossRef
148.
Banerjee S, Maji D, Baruah M. Addition of insulin aspart with basal insulin is associated with improved glycemic control in Indian patients with uncontrolled type 2 diabetes mellitus: the A1chieve observational study. J Assoc Physicians India. 2013;61 Suppl 1:24–7.PubMed
149.
Bebakar WM, Lim-Abrahan MA, Jain AB, Seah D, Soewondo P. Safety and effectiveness of insulin aspart in type 2 diabetic patients: results from the ASEAN cohort of the A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S17–23.PubMedCrossRef
150.
Belhadj M, Dahaoui A, Jamoussi H, Farouqi A. Exploring insulin analogue safety and effectiveness in a Maghrebian cohort with type 2 diabetes: results from the A1chieve study. Diabetes Res Clin Pract. 2013;101 Suppl 1:S4–14.PubMedCrossRef
151.
Chen L, Xing X, Lei M, Liu J, Shi Y, Li P, et al. Biphasic insulin aspart 30 improved glycemic control in Chinese patients with type 2 diabetes poorly controlled on oral glucose-lowering drugs: a subgroup analysis of the A1chieve study. Chin Med J (Engl). 2014;127:208–12.
152.
Chraibi A, Ajdi F, Belkhadir J, El Ansari N, Marouan F, Farouqi A. Safety and effectiveness of insulin analogues in Moroccan patients with type 2 diabetes: a sub-analysis of the A1chieve study. Diabetes Res Clin Pract. 2013;101 Suppl 1:S27–36.PubMedCrossRef
153.
Dieuzeide G, Chuang LM, Almaghamsi A, Zilov A, Chen JW, Lavalle-González FJ. Safety and effectiveness of biphasic insulin aspart 30 in people with type 2 diabetes switching from basal-bolus insulin regimens in the A1chieve study. Prim Care Diabetes. 2014;8:111–7.PubMedCrossRef
154.
Haddad J, Khoshniatnikoo M, Benabbas Y, Guler S, Prusty V, Soewondo P. Safety and effectiveness of switching from a basal-only to biphasic insulin Aspart 30 insulin regimen. Diabetes Ther. 2013;4:309–19.PubMedCentralPubMedCrossRef
155.
Hassan MI, Aamir AH, Miyan Z, Siddiqui LA, Mahmood S, Vohra EA. Switch from biphasic human insulin 30 to biphasic insulin aspart 30 in Pakistani subjects. J Pak Med Assoc. 2013;63:1290–4.PubMed
156.
Home PD, Latif ZA, González-Gálvez G, Prusty V, Hussein Z. The effectiveness and safety of beginning insulin aspart together with basal insulin in people with type 2 diabetes in non-Western nations: results from the A1chieve observational study. Diabetes Res Clin Pract. 2013;101:326–32.PubMedCrossRef
157.
Home PD, Shen C, Hasan MI, Latif ZA, Chen JW, González GG. Predictive and explanatory factors of change in HbA1c in a 24-week observational study of 66,726 people with type 2 diabetes starting insulin analogs. Diabetes Care. 2014;37:1237–45.PubMedCrossRef
158.
Hussein Z, Lim-Abrahan MA, Jain AB, Goh SY, Soewondo P. Switching from biphasic human insulin to biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN subgroup of the A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S24–9.PubMedCrossRef
159.
Khamseh ME, Haddad J, Yang W, Zilov A, Bech OM, Hasan MI. Safety and effectiveness of biphasic insulin aspart 30 in different age-groups: a1chieve sub-analysis. Diabetes Ther. 2013;4:347–61.PubMedCentralPubMedCrossRef
160.
Kumar A, Sharma SK, Rajput R, Unnikrishnan AG. Initiating therapy or switching to biphasic insulin aspart improves glycaemic control in type 2 diabetes: an Indian experience from the A1chieve study. J Assoc Physicians India. 2013;61 Suppl 1:16–20.PubMed
161.
Latif ZA, Hussein Z, Litwak L, El Naggar N, Chen JW, Soewondo P. Safety and effectiveness of insulin aspart in Basal-bolus regimens regardless of age: a1chieve study results. Diabetes Ther. 2013;4:103–18.PubMedCentralPubMedCrossRef
162.
Latif ZA, Pathan MF, Siddiqui MN, Sobhan MJ, Rahman MM, Ashrafuzzaman SM. Safety and effectiveness of biphasic insulin aspart 30 in a Bangladeshi subgroup of type 2 diabetic patients switched from biphasic human insulin 30: a sub-analysis of the A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S30–4.PubMedCrossRef
163.
Lezzar A, Ayad F, Dahaoui A, Salah-Mansour A, Berrouiguet AY. Initiating or switching to biphasic insulin aspart 30 in type 2 diabetes patients from Algeria: a sub-analysis of the A1chieve study. Diabetes Res Clin Pract. 2013;101 Suppl 1:S37–44.PubMedCrossRef
164.
Lim-Abrahan MA, Jain AB, Bebakar WM, Seah D, Soewondo P. Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes: results from the ASEAN cohort of the A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S3–9.PubMedCrossRef
165.
Lim-Abrahan MA, Yu-Gan S, Jain AB, Sobrepena LM, Racho VA. Safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Filipino cohort of the A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S35–40.PubMedCrossRef
166.
Malek R, Arbouche Z, Dahaoui A, Bachaoui M. Safety and effectiveness of insulin analogues in type 2 diabetic patients from Algeria: a sub-analysis of the A1chieve study. Diabetes Res Clin Pract. 2013;101 Suppl 1:S15–26.PubMedCrossRef
167.
Malek R, Gonzalez-Galvez G, El Naggar N, Shah S, Prusty V, Litwak L. Safety and effectiveness of insulin detemir in different age-groups in the a1chieve study. Diabetes Ther. 2013;4:77–90.PubMedCentralPubMedCrossRef
168.
Malek R, Arbouche Z, Bachaoui M, Zinai S, Dahaoui A, Senoussaoui S, et al. Criteria influencing the choice of starting insulin regimen in patients with type 2 diabetes in routine clinical practice: baseline data from the Algerian cohort of the A1chieve study. Diabetes Res Clin Pract. 2013;101 Suppl 1:S45–9.PubMedCrossRef
169.
Randeree H, Liebl A, Hajjaji I, Khamseh M, Zajdenverg L, Chen JW, et al. Safety and effectiveness of bolus insulin aspart in people with type 2 diabetes: a1chieve sub-analysis. Diabetes Ther. 2013;4:153–66.PubMedCentralPubMedCrossRef
170.
Rao PV, Bhattacharyya A, Sahay RK. Initiation of insulin aspart to Indian subjects on OADs show significant improvement in glycaemic outcomes: the A1chieve observational study. J Assoc Physicians India. 2013;61 Suppl 1:21–3.PubMed
171.
Shah S, Yang W, Hasan MI, Malek R, Molskov Bech O, Home P. Biphasic insulin aspart 30 in insulin-naive people with type 2 diabetes in non-western nations: results from a regional comparative multinational observational study (A(1)chieve). Diabetes Technol Ther. 2013;15:954–63.PubMedCrossRef
172.
Soewondo P, Pramono RB, Langi YA, Soetedjo NN, Kshanti IA. Clinical experience with BIAsp 30: results from the Indonesian cohort of the international A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S54–9.PubMedCrossRef
173.
Soewondo P, Mohamed M, Jain AB, Sy RA, Khoo CM. Safety and effectiveness of insulin detemir in type 2 diabetes: results from the ASEAN cohort of the A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S10–6.PubMedCrossRef
174.
Soewondo P, Lindarto D, Wibisono S, Renaldi O, Dalem-Pemayun TG. Clinical safety and effectiveness of biphasic insulin aspart 30 in type 2 diabetes patients switched from biphasic human insulin 30: results from the Indonesian cohort of the A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S41–6.PubMedCrossRef
175.
Soewondo P, Kshanti IA, Pramono RB, Langi YA, Dalem-Pemayun TG. Clinical experience with insulin detemir: results from the Indonesian cohort of the international A1chieve study. Diabetes Res Clin Pract. 2013;100 Suppl 1:S47–53.PubMedCrossRef
176.
Zilov A, El Naggar N, Shah S, Shen C, Haddad J. Insulin detemir in the management of type 2 diabetes in non-Western countries: safety and effectiveness data from the A1chieve observational study. Diabetes Res Clin Pract. 2013;101:317–25.PubMedCrossRef
177.
Valensi P, Shaban J, Benroubi M, Kawamori R, Borzì V, Shah S, et al. Predictors of achieving HbA(1c) <7% and no hypoglycaemia 6 months after initiation of biphasic insulin aspart 30 in patients with type 2 diabetes in the IMPROVE study. Curr Med Res Opin. 2013;29:601–9.PubMedCrossRef
178.
Caputo S, Andersen H, Kaiser M, Karnieli E, Meneghini LF, Svendsen AL. Effect of baseline glycosylated hemoglobin A1c on glycemic control and diabetes management following initiation of once-daily insulin detemir in real-life clinical practice. Endocr Pract. 2013;19:462–70.PubMedCrossRef
179.
Karnieli E, Baeres FM, Dzida G, Ji Q, Ligthelm R, Ross S, et al. Observational study of once-daily insulin detemir in people with type 2 diabetes aged 75 years or older: a sub-analysis of data from the Study of Once daily LeVEmir (SOLVE). Drugs Aging. 2013;30:167–75.PubMedCentralPubMedCrossRef
180.
Ross S, Dzida G, Ji Q, Kaiser M, Ligthelm R, Meneghini L, et al. Safety of once-daily insulin detemir in patients with type 2 diabetes treated with oral hypoglycemic agents in routine clinical practice. J Diabetes. 2014;6:243–50.PubMedCrossRef
181.
Vora J, Caputo S, Damci T, Orozco-Beltran D, Pan C, Svendsen AL, et al. Effect of once-daily insulin detemir on oral antidiabetic drug (OAD) use in patients with type 2 diabetes. J Clin Pharm Ther. 2014;39:136–43.PubMedCrossRef
182.
Gönen MS, Yürümez A, Hersek Ö, Altunoğlu E, Rakıcı H, Scism-Bacon J, et al. The risk of severe hypoglycaemia in patients with type 2 diabetes mellitus starting insulin therapy with premixed insulin analogues taken twice daily: an observational study in Turkish patients. Turk Jem. 2013;17:83–8.
183.
Walz L, Pettersson B, Rosenqvist U, Deleskog A, Journath G, Wändell P. Impact of symptomatic hypoglycemia on medication adherence, patient satisfaction with treatment, and glycemic control in patients with type 2 diabetes. Patient Prefer Adherence. 2014;30(8):593–601.CrossRef
184.
Karagiannis T, Paschos P, Paletas K, Matthews DR, Tsapas A. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and meta-analysis. BMJ. 2012;344:e1369.PubMedCrossRef
185.
Berlie H, Hurren KM, Pinelli NR. Glucagon-like peptide-1 receptor agonists as add-on therapy to basal insulin in patients with type 2 diabetes: a systematic review. Diabetes Metab Syndr Obes. 2012;5:165–74.PubMedCentralPubMed
186.
Black C, Donnelly P, McIntyre L, Royle PL, Shepherd JP, Thomas S. Meglitinide analogues for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2007;2:CD004654.PubMed
187.
Gangji AS, Cukierman T, Gerstein HC, Goldsmith CH, Clase CM. A systematic review and meta-analysis of hypoglycemia and cardiovascular events: a comparison of glyburide with other secretagogues and with insulin. Diabetes Care. 2007;30:389–94.PubMedCrossRef
188.
Monami M, Iacomelli I, Marchionni N, Mannucci E. Dipeptydil peptidase-4 inhibitors in type 2 diabetes: a meta-analysis of randomized clinical trials. Nutr Metab Cardiovasc Dis. 2010;20:224–35.PubMedCrossRef
189.
Norris SL, Lee N, Thakurta S, Chan BK. Exenatide efficacy and safety: a systematic review. Diabet Med. 2009;26:837–46.PubMedCrossRef
190.
Pinelli NR, Cha R, Brown MB, Jaber LA. Addition of thiazolidinedione or exenatide to oral agents in type 2 diabetes: a meta-analysis. Ann Pharmacother. 2008;42:1541–51.PubMedCrossRef
191.
Pinelli NR, Hurren KM. Efficacy and safety of long-acting glucagon-like peptide-1 receptor agonists compared with exenatide twice daily and sitagliptin in type 2 diabetes mellitus: a systematic review and meta-analysis. Ann Pharmacother. 2011;45:850–60.PubMedCrossRef
192.
Richter B, Bandeira-Echtler E, Bergerhoff K, Lerch C. Emerging role of dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes. Vasc Health Risk Manag. 2008;4:753–68.PubMedCentralPubMed
193.
Richter B, Bandeira-Echtler E, Bergerhoff K, Lerch CL. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. Cochrane Database Syst Rev. 2008;2:CD006739.PubMed
194.
Shyangdan DS, Royle PL, Clar C, Sharma P, Waugh NR. Glucagon-like peptide analogues for type 2 diabetes mellitus: systematic review and meta-analysis. BMC Endocr Disord. 2010;10:20.PubMedCentralPubMedCrossRef
195.
Wang Y, Li L, Yang M, Liu H, Boden G, Yang G. Glucagon-like peptide-1 receptor agonists versus insulin in inadequately controlled patients with type 2 diabetes mellitus: a meta-analysis of clinical trials. Diabetes Obes Metab. 2011;13:972–81.PubMedCrossRef
196.
Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients. Diabet Med. 2002;19:393–9.PubMedCrossRef
197.
Chapman TM, Noble S, Goa KL. Insulin aspart: a review of its use in the management of type 1 and 2 diabetes mellitus. Drugs. 2002;62:1945–81.PubMedCrossRef
198.
Chapman TM, Noble S, Goa KL. Spotlight on insulin aspart in type 1 and 2 diabetes mellitus. Treat Endocrinol. 2003;2:71–6.PubMedCrossRef
199.
Chen JW, Lauritzen T, Bojesen A, Christiansen JS. Multiple mealtime administration of biphasic insulin aspart 30 versus traditional basal-bolus human insulin treatment in patients with type 1 diabetes. Diabetes Obes Metab. 2006;8:682–9.PubMedCrossRef
200.
Ceriello A, Cremasco F, Romoli E, Rossi A, Gentilella R. Insulin lispro protamine suspension in the treatment of patients with type 1 and type 2 diabetes mellitus: a systematic review of published data. Expert Opin Pharmacother. 2012;13:255–81.PubMedCrossRef
201.
Clements MR, Tits J, Kinsley BT, Råstam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008;10:229–37.PubMedCrossRef
202.
Davidson J, Vexiau P, Cucinotta D, Vaz J, Kawamori R. Biphasic insulin aspart 30: literature review of adverse events associated with treatment. Clin Ther. 2005;27(Suppl B):S75–88.PubMedCrossRef
203.
Mortensen H, Kocova M, Teng LY, Keiding J, Bruckner I, Philotheou A. Biphasic insulin aspart vs. human insulin in adolescents with type 1 diabetes on multiple daily insulin injections. Pediatr Diabetes. 2006;7:4–10.PubMedCrossRef
204.
205.
Raja-Khan N, Warehime SS, Gabbay RA. Review of biphasic insulin aspart in the treatment of type 1 and 2 diabetes. Vasc Health Risk Manag. 2007;3:919–35.PubMedCentralPubMed
206.
Roach P, Bai S, Charbonnel B, Consoli A, Taboga C, Tiengo A, et al. Effects of multiple daily injection therapy with Humalog mixtures versus separately injected insulin lispro and NPH insulin in adults with type I diabetes mellitus. Clin Ther. 2004;26:502–10.PubMedCrossRef
207.
Rys P, Pankiewicz O, Łach K, Kwaskowski A, Skrzekowska-Baran I, Malecki MT. Efficacy and safety comparison of rapid-acting insulin aspart and regular human insulin in the treatment of type 1 and type 2 diabetes mellitus: a systematic review. Diabetes Metab. 2011;37:190–200.PubMedCrossRef
208.
209.
Velásquez-Mieyer PA, Neira CP. Biphasic insulin aspart 30 for the treatment of type 1 diabetes mellitus. Expert Opin Pharmacother. 2008;9:2377–82.PubMedCrossRef
210.
Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S, et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med. 2007;147:386–99.PubMedCrossRef
211.
Goto A, Arah OA, Goto M, Terauchi Y, Noda M. Severe hypoglycaemia and cardiovascular disease: systematic review and meta-analysis with bias analysis. BMJ. 2013;347:f4533.PubMedCrossRef
Metadata
Title
Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis
Authors
Marcin Czech
Elżbieta Rdzanek
Justyna Pawęska
Olga Adamowicz-Sidor
Maciej Niewada
Michał Jakubczyk
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Endocrine Disorders / Issue 1/2015
Electronic ISSN: 1472-6823
DOI
https://doi.org/10.1186/s12902-015-0052-z

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