Skip to main content
Top
Published in: Diabetes Therapy 1/2013

Open Access 01-06-2013 | Original Research

Safety and Effectiveness of Insulin Detemir in Different Age-Groups in the A1chieve Study

Authors: Rachid Malek, Guillermo Gonzalez-Galvez, Nabil El Naggar, Siddharth Shah, Vinay Prusty, Leon Litwak

Published in: Diabetes Therapy | Issue 1/2013

Login to get access

Abstract

Introduction

Diabetes therapy should balance glycemic control with risk of adverse events. This sub-analysis of the A1chieve study evaluated clinical safety and effectiveness of insulin detemir in different age-groups (≤40 years, >40–65 years, and >65 years) of insulin-experienced and insulin-naïve people with type 2 diabetes.

Methods

A1chieve was an international, open-label, non-interventional, 24-week study in 66,726 people with type 2 diabetes starting/switching to therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness in patients starting/switching to insulin detemir (±oral glucose-lowering drugs).

Results

In total, 15,241 patients were included in the sub-analysis. In all age-groups, the proportion of participants experiencing any, major or nocturnal hypoglycemia was significantly (all p < 0.05) reduced relative to baseline, except in insulin-naïve patients for any and nocturnal hypoglycemia, where there was a significant increase or no significant change in patients aged >65 years and >40–65 years, respectively, and no significant change in major hypoglycemia in insulin-naïve patients aged ≤40 years. Seven serious adverse drug reactions were reported. Body weight was significantly reduced in patients aged ≤40 years and >40–65 years and significantly increased in insulin-naïve patients aged >65 years at 24 weeks. At 24 weeks, glycated hemoglobin was reduced by 2.3%, 2.0%, and 1.8%, in the ≤40 years, >40–65 years, and >65 years age-groups, respectively (all p < 0.001). Fasting and post-prandial plasma glucose were significantly reduced and health-related quality of life (HRQoL) significantly improved across all patient cohorts (all p < 0.001).

Conclusion

After 24-week treatment with insulin detemir, all age-groups of insulin-experienced and insulin-naïve patients had significantly improved glycemic control and HRQoL. The proportion of patients experiencing hypoglycemia was reduced in all age-groups but unchanged in insulin-naïve patients aged >40–65 years and increased in insulin-naïve patients aged >65 years. The safety and effectiveness of insulin detemir may benefit all age-groups.
Literature
1.
go back to reference International Diabetes Federation. IDF Diabetes Atlas 2012 Update, 5th edn. Brussels, Belgium; 2012. International Diabetes Federation. IDF Diabetes Atlas 2012 Update, 5th edn. Brussels, Belgium; 2012.
2.
go back to reference The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977–86.CrossRef The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977–86.CrossRef
3.
go back to reference 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 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
4.
go back to reference International Diabetes Federation. IDF Clinical Guidelines Task Force. Global guideline for type 2 diabetes. Brussels, Belgium; 2012. International Diabetes Federation. IDF Clinical Guidelines Task Force. Global guideline for type 2 diabetes. Brussels, Belgium; 2012.
5.
go back to reference Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364–79.PubMedCrossRef Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012;35:1364–79.PubMedCrossRef
6.
go back to reference National Institute for Health and Clinical Excellence. National Institute for Health and Clinical Excellence (NICE) Guidelines. Type 2 diabetes: the management of type 2 diabetes; 2008. National Institute for Health and Clinical Excellence. National Institute for Health and Clinical Excellence (NICE) Guidelines. Type 2 diabetes: the management of type 2 diabetes; 2008.
7.
go back to reference Olson DE, Norris SL. Diabetes in older adults. Overview of AGS guidelines for the treatment of diabetes mellitus in geriatric populations. Geriatrics. 2004;59:18–24 quiz 5.PubMed Olson DE, Norris SL. Diabetes in older adults. Overview of AGS guidelines for the treatment of diabetes mellitus in geriatric populations. Geriatrics. 2004;59:18–24 quiz 5.PubMed
8.
go back to reference Plank J, Bodenlenz M, Sinner F, et al. A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabetes Care. 2005;28:1107–12.PubMedCrossRef Plank J, Bodenlenz M, Sinner F, et al. A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabetes Care. 2005;28:1107–12.PubMedCrossRef
9.
go back to reference Klein O, Lynge J, Endahl L, Damholt B, Nosek L, Heise T. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab. 2007;9:290–9.PubMedCrossRef Klein O, Lynge J, Endahl L, Damholt B, Nosek L, Heise T. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab. 2007;9:290–9.PubMedCrossRef
10.
go back to reference Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab. 2007;9:648–59.PubMedCrossRef Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab. 2007;9:648–59.PubMedCrossRef
11.
go back to reference Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006;28:1569–81.PubMedCrossRef Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006;28:1569–81.PubMedCrossRef
12.
go back to reference Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006;29:1269–74.PubMedCrossRef Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006;29:1269–74.PubMedCrossRef
13.
go back to reference Khunti K, Caputo S, Damci T, 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. doi:10.1111/j.1463-1326.2012.01665.x. Khunti K, Caputo S, Damci T, 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. doi:10.​1111/​j.​1463-1326.​2012.​01665.​x.
14.
go back to reference Perriello G, Caputo S, De Pergola G, et al. Improved glycemic control with weight loss and a low risk of hypoglycemia 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 Perriello G, Caputo S, De Pergola G, et al. Improved glycemic control with weight loss and a low risk of hypoglycemia 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
15.
go back to reference Home P, Naggar NE, Khamseh M, 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 Home P, Naggar NE, Khamseh M, 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
16.
go back to reference 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 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
17.
go back to reference International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices (GPP). Revision 2; 2007. International Society for Pharmacoepidemiology. Guidelines for Good Pharmacoepidemiology Practices (GPP). Revision 2; 2007.
19.
go back to reference EuroQol—a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16:199–208. EuroQol—a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990;16:199–208.
20.
go back to reference Chan TY. Estimates on the incidence of antidiabetic drug-induced severe hypoglycaemia in Hong Kong. Pharmacoepidemiol Drug Saf. 1998;7:411–4.PubMedCrossRef Chan TY. Estimates on the incidence of antidiabetic drug-induced severe hypoglycaemia in Hong Kong. Pharmacoepidemiol Drug Saf. 1998;7:411–4.PubMedCrossRef
21.
go back to reference Brown AF, Mangione CM, Saliba D, Sarkisian CA. Guidelines for improving the care of the older person with diabetes mellitus. J Am Geriatr Soc. 2003;51:S265–80.PubMedCrossRef Brown AF, Mangione CM, Saliba D, Sarkisian CA. Guidelines for improving the care of the older person with diabetes mellitus. J Am Geriatr Soc. 2003;51:S265–80.PubMedCrossRef
22.
go back to reference Barendse S, Singh H, Frier BM, Speight J. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in type 2 diabetes: a narrative review. Diabet Med. 2012;29:293–302.PubMedCrossRef Barendse S, Singh H, Frier BM, Speight J. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in type 2 diabetes: a narrative review. Diabet Med. 2012;29:293–302.PubMedCrossRef
23.
go back to reference Jacobson AM. Impact of improved glycemic control on quality of life in patients with diabetes. Endocr Pract. 2004;10:502–8.PubMedCrossRef Jacobson AM. Impact of improved glycemic control on quality of life in patients with diabetes. Endocr Pract. 2004;10:502–8.PubMedCrossRef
24.
go back to reference Bodmer M, Meier C, Krahenbuhl S, Jick SS, Meier CR. Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. Diabetes Care. 2008;31:2086–91.PubMedCrossRef Bodmer M, Meier C, Krahenbuhl S, Jick SS, Meier CR. Metformin, sulfonylureas, or other antidiabetes drugs and the risk of lactic acidosis or hypoglycemia: a nested case-control analysis. Diabetes Care. 2008;31:2086–91.PubMedCrossRef
Metadata
Title
Safety and Effectiveness of Insulin Detemir in Different Age-Groups in the A1chieve Study
Authors
Rachid Malek
Guillermo Gonzalez-Galvez
Nabil El Naggar
Siddharth Shah
Vinay Prusty
Leon Litwak
Publication date
01-06-2013
Publisher
Springer Healthcare
Published in
Diabetes Therapy / Issue 1/2013
Print ISSN: 1869-6953
Electronic ISSN: 1869-6961
DOI
https://doi.org/10.1007/s13300-013-0021-3

Other articles of this Issue 1/2013

Diabetes Therapy 1/2013 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine

Highlights from the ACC 2024 Congress

Year in Review: Pediatric cardiology

Watch Dr. Anne Marie Valente present the last year's highlights in pediatric and congenital heart disease in the official ACC.24 Year in Review session.

Year in Review: Pulmonary vascular disease

The last year's highlights in pulmonary vascular disease are presented by Dr. Jane Leopold in this official video from ACC.24.

Year in Review: Valvular heart disease

Watch Prof. William Zoghbi present the last year's highlights in valvular heart disease from the official ACC.24 Year in Review session.

Year in Review: Heart failure and cardiomyopathies

Watch this official video from ACC.24. Dr. Biykem Bozkurt discusses last year's major advances in heart failure and cardiomyopathies.