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Published in: Cardiovascular Diabetology 1/2010

Open Access 01-12-2010 | Original investigation

Continuous glucose monitoring with Humalog Mix 25 versus Humalog Mix 50, twice daily: A comparative pilot study -Results from the Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariancE (J-EVOLVE) study

Authors: Rimei Nishimura, Daisuke Tsujino, Kentaro Taki, Aya Morimoto, Naoko Tajima

Published in: Cardiovascular Diabetology | Issue 1/2010

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Abstract

Objective

To evaluate glycemic variability associated with two different premixed insulin analogue formulations when used in a twice-daily regimen.

Patients and Methods

Subjects comprised type 2 diabetic patients aged 20-79 years, treated with twice daily premixed insulin or insulin analogue formulations. All subjects were hospitalized for 6 days and randomized to receive either Humalog Mix 25 (Mix 25) or Humalog Mix 50 (Mix 50). They were then crossed over to the other arm between day 3 and day 4 of the study. Continuous glucose monitoring (CGM) was performed on all subjects to examine the differences in glycemic variability.

Results

Eleven type 2 diabetic patients were enrolled. No significant difference was found in 24-hour mean glucose values and their SDs, pre-meal glucose values, increases from pre-meal to peak glucose values, or time to peak glucose levels between either group. However, the mean glucose values observed during 0-8 hrs were significantly lower with Mix 25 compared to Mix 50 (128 vs. 147 mg/dL; p = 0.024).

Conclusions

The twice-daily Mix 25 regimen provided superior overnight glycemic control compared to the Mix 50 regimen in Japanese patients with type 2 diabetes. However, both twice-daily regimens with either Mix 25 or Mix 50 provided inadequate post-lunch glycemic control.

Trial Registration

Current Controlled Trials UMIN000001327
Appendix
Available only for authorised users
Literature
1.
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: 977-986. 10.1056/NEJM199309303291401.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: 977-986. 10.1056/NEJM199309303291401.CrossRef
2.
go back to reference Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M: Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995, 28: 103-117. 10.1016/0168-8227(95)01064-K.CrossRefPubMed Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M: Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995, 28: 103-117. 10.1016/0168-8227(95)01064-K.CrossRefPubMed
3.
go back to reference Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC: Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007, 357: 1716-1730. 10.1056/NEJMoa075392.CrossRefPubMed Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC: Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007, 357: 1716-1730. 10.1056/NEJMoa075392.CrossRefPubMed
4.
go back to reference Miyashita Y, Nishimura R, Nemoto M, Matsudaira T, Kurata H, Yokota T, Yokota K, Tojo K, Utsunomiya K, Tajima N: Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure. Cardiovasc Diabetol. 2008, 7: 16-10.1186/1475-2840-7-16.PubMedCentralCrossRefPubMed Miyashita Y, Nishimura R, Nemoto M, Matsudaira T, Kurata H, Yokota T, Yokota K, Tojo K, Utsunomiya K, Tajima N: Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure. Cardiovasc Diabetol. 2008, 7: 16-10.1186/1475-2840-7-16.PubMedCentralCrossRefPubMed
5.
go back to reference Hirao K, Arai K, Yamauchi M, Takagi H, Kobayashi M, Japan Diabetes Clinical Data Management Study Group: Six-month multicentric, open-label, randomized trial of twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart in Japanese type 2 diabetic patients (JDDM 11). Diabetes Res Clin Pract. 2008, 79: 171-6. 10.1016/j.diabres.2007.08.011.CrossRefPubMed Hirao K, Arai K, Yamauchi M, Takagi H, Kobayashi M, Japan Diabetes Clinical Data Management Study Group: Six-month multicentric, open-label, randomized trial of twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart in Japanese type 2 diabetic patients (JDDM 11). Diabetes Res Clin Pract. 2008, 79: 171-6. 10.1016/j.diabres.2007.08.011.CrossRefPubMed
6.
go back to reference Yoshino G, Tominagab M, Hirano T, Shiba T, Kashiwagi A, Tanaka A, Tada N, Onuma T, Egusa G, Kuwashima M, Sanke T, Oikawa S, Honda K, Tachikawa T: The Test Meal A: A Pilot Model for the International Standard of Test Meal for an Assessment of Both Postprandial Hyperglycemia and Hyperlipidemia. J Jpn Diabetes Soc. 2006, 49: 361-371. Yoshino G, Tominagab M, Hirano T, Shiba T, Kashiwagi A, Tanaka A, Tada N, Onuma T, Egusa G, Kuwashima M, Sanke T, Oikawa S, Honda K, Tachikawa T: The Test Meal A: A Pilot Model for the International Standard of Test Meal for an Assessment of Both Postprandial Hyperglycemia and Hyperlipidemia. J Jpn Diabetes Soc. 2006, 49: 361-371.
7.
go back to reference Boyne MS, Silver DM, Kaplan J, Saudek CD: Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor. Diabetes. 2003, 52: 2790-4. 10.2337/diabetes.52.11.2790.CrossRefPubMed Boyne MS, Silver DM, Kaplan J, Saudek CD: Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor. Diabetes. 2003, 52: 2790-4. 10.2337/diabetes.52.11.2790.CrossRefPubMed
10.
go back to reference Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S: Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008, 31: 20-5. 10.2337/dc07-1122.CrossRefPubMed Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S: Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008, 31: 20-5. 10.2337/dc07-1122.CrossRefPubMed
11.
go back to reference Hirao K, Maeda H, Urata S, Takisawa Y, Hirao S, Sasako T, Sasaki T: Comparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan. Clin Ther. 2007, 29: 927-34. 10.1016/j.clinthera.2007.05.017.CrossRefPubMed Hirao K, Maeda H, Urata S, Takisawa Y, Hirao S, Sasako T, Sasaki T: Comparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan. Clin Ther. 2007, 29: 927-34. 10.1016/j.clinthera.2007.05.017.CrossRefPubMed
12.
go back to reference McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A: Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002, 24: 530-9. 10.1016/S0149-2918(02)85129-3.CrossRefPubMed McSorley PT, Bell PM, Jacobsen LV, Kristensen A, Lindholm A: Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. Clin Ther. 2002, 24: 530-9. 10.1016/S0149-2918(02)85129-3.CrossRefPubMed
13.
go back to reference 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. 10.1046/j.1464-5491.2002.00733.x.CrossRefPubMed 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. 10.1046/j.1464-5491.2002.00733.x.CrossRefPubMed
Metadata
Title
Continuous glucose monitoring with Humalog Mix 25 versus Humalog Mix 50, twice daily: A comparative pilot study -Results from the Jikei-EValuation of insulin Lispro mixture on pharmacodynamics and glycemic VariancE (J-EVOLVE) study
Authors
Rimei Nishimura
Daisuke Tsujino
Kentaro Taki
Aya Morimoto
Naoko Tajima
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Cardiovascular Diabetology / Issue 1/2010
Electronic ISSN: 1475-2840
DOI
https://doi.org/10.1186/1475-2840-9-16

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