Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

Summary

This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Timeline

Start

2007-05

Primary completion

2008-04

Completion

2008-04

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); BIAsp 30 vs Glargine; p = 0.029; Mean Difference (Net) -0.16 (95% CI -0.30 to -0.02) NCT00469092 ↗

paper With respect to HbA(1c), BIAsp 30 fulfilled the statistical criteria for non-inferiority and superiority to insulin glargine PMID 19821654 ↗

Publications

• Results Strojek K, Bebakar WM, Khutsoane DT, Pesic M, Smahelova A, Thomsen HF, Kalra S. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009 Dec;25(12):2887-94. doi: 10.1185/03007990903354674.
• Results Kalra S, Plata-Que T, Kumar D, Mumtaz M, Sondergaard F, Kozlovski P, Bebakar WM. Initiation with once-daily BIAsp 30 results in superior outcome compared to insulin glargine in Asians with type 2 diabetes inadequately controlled by oral anti-diabetic drugs. Diabetes Res Clin Pract. 2010 Jun;88(3):282-8. doi: 10.1016/j.diabres.2010.03.004. Epub 2010 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	biphasic insulin aspart	Protein / enzyme biologic	—	—
Comparator	insulin glargine	Protein / enzyme biologic	—	—
Background	Glimepiride	Small molecule	4 mg	—
Background	Glimepiride	Small molecule	6 mg	—
Background	Glimepiride	Small molecule	8 mg	—
Background	Metformin	Small molecule	2550 ug	—

Indications