drugset / Trial / NCT00101712
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo 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 and whose blood glucose levels are close to normal.
Timeline
- Start
- 2004-10
- Primary completion
- 2006-05
- Completion
- 2006-05
Publications
- Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Jauffret S, Foley JE. Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia*. Diabetes Obes Metab. 2008 Aug;10(8):675-82. doi: 10.1111/j.1463-1326.2008.00850.x. Epub 2007 Nov 22.
- Mari A, Scherbaum WA, Nilsson PM, Lalanne G, Schweizer A, Dunning BE, Jauffret S, Foley JE. Characterization of the influence of vildagliptin on model-assessed -cell function in patients with type 2 diabetes and mild hyperglycemia. J Clin Endocrinol Metab. 2008 Jan;93(1):103-9. doi: 10.1210/jc.2007-1639. Epub 2007 Oct 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vildagliptin | Other / unclassified | 50 mg | — |