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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 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 148 participants.

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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

FieldValue
Enrollment Target 148 participants
Start Date 2008-01
Est. Completion 2010-10
Phase Phase 3

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00616811

The ClinicalTrials.gov registry entry for NCT00616811 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 148 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.

NCT00616811 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.