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NCT00770081 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT00770081: Completed Phase 3 study, sponsored by Novartis.
NCT00770081 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 75 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00770081, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study 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.
Interventions
- DRUG sitagliptin
- DRUG vildagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2008-09 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00770081 record still lists
NCT00770081 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which sitagliptin is the first listed.
NCT00770081 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00770081 about?
NCT00770081 is a clinical study titled "Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency (28-week Extension Study)". 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)...
What is the current status of trial NCT00770081?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2008-09. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00770081?
The interventions under investigation include: sitagliptin (DRUG), vildagliptin (DRUG).
Who is sponsoring clinical trial NCT00770081?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00770081's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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