drugset / Trial / NCT00102388
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
Timeline
- Start
- 2005-01
- Primary completion
- 2008-03
- Completion
- —
Publications
- Results Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naive patients with type 2 diabetes. Horm Metab Res. 2009 Dec;41(12):905-9. doi: 10.1055/s-0029-1234042. Epub 2009 Aug 24.
- Results Filozof C, Schwartz S, Foley JE. Effect of vildagliptin as add-on therapy to a low-dose metformin. World J Diabetes. 2010 Mar 15;1(1):19-26. doi: 10.4239/wjd.v1.i1.19.
- Results Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gliclazide | Small molecule | 320 mg | — |
| Subject | Vildagliptin | Other / unclassified | 50 mg | — |