Trials / Completed
CompletedNCT00770081
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
A 28-week Extension to a 24-week Multicenter, Randomized, Double-blind, Active-controlled Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Sitagliptin (25 mg qd) in Patients With Type 2 Diabetes and Severe Renal Insufficiency
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) \< 30 mL/min) for a period of 52 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | vildagliptin | 50mg qd |
| DRUG | sitagliptin | 25mg qd |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2008-10-09
- Last updated
- 2020-12-17
Locations
87 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00770081. Inclusion in this directory is not an endorsement.