drugset / Trial / NCT00469092
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
RandomizedParallel-groupOpen-labelTreatment
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
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 | — |