drugset / Trial / NCT00232583
Preservation of Beta-cell Function in Type 2 Diabetes Mellitus
RandomizedParallel-groupOpen-labelTreatment
Summary
The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.
Timeline
- Start
- 2003-11
- Primary completion
- 2011-12
- Completion
- 2011-12
Publications
- Results Lingvay I, Kaloyanova PF, Adams-Huet B, Salinas K, Raskin P. Insulin as initial therapy in type 2 diabetes: effective, safe, and well accepted. J Investig Med. 2007 Mar;55(2):62-8. doi: 10.2310/6650.2007.06036.
- Harrison LB, Adams-Huet B, Raskin P, Lingvay I. beta-cell function preservation after 3.5 years of intensive diabetes therapy. Diabetes Care. 2012 Jul;35(7):1406-12. doi: 10.2337/dc11-2170.
- Lingvay I, Legendre JL, Kaloyanova PF, Zhang S, Adams-Huet B, Raskin P. Insulin-based versus triple oral therapy for newly diagnosed type 2 diabetes: which is better? Diabetes Care. 2009 Oct;32(10):1789-95. doi: 10.2337/dc09-0653. Epub 2009 Jul 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glyburide | Small molecule | — | — |
| Comparator | Insulin | Protein / enzyme biologic | — | — |
| Comparator | Pioglitazone | Small molecule | 45 mg | — |
| Comparator | Metformin | Small molecule | 1000 mg | — |