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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 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 75 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00770081
The ClinicalTrials.gov registry entry for NCT00770081 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which sitagliptin is the first listed.
NCT00770081 reports 0 study locations.
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.
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