Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00616811 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
NCT00616811: Completed Phase 3 study, sponsored by Novartis.
NCT00616811 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 148 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616811, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 148 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 24 weeks.
Interventions
- DRUG Sitagliptin
- DRUG vildagliptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-10 |
| Phase | Phase 3 |
What the finished NCT00616811 record still lists
NCT00616811 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Sitagliptin is the first listed.
NCT00616811 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616811 about?
NCT00616811 is a clinical study titled "Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and Severe Renal Insufficiency". 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 NCT00616811?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2008-01. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00616811?
The interventions under investigation include: Sitagliptin (DRUG), vildagliptin (DRUG).
Who is sponsoring clinical trial NCT00616811?
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 NCT00616811's enrollment target sits among peer trials
148 1547th of 2000 higher than 451 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00739362 · 148 participants · Phase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
- NCT03161223 · 148 participants · Phase 1
Durvalumab in Different Combinations With Pralatrexate, Romidepsin and Oral 5-Azacitidine for Lymphoma
- NCT03858231 · 148 participants · Phase 4
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
- NCT04486352 · 148 participants · Phase 1
A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia