Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Vildagliptin; Drug: Placebo

• Registration Number: NCT00646542
• Lead Sponsor: Novartis

Brief Summary

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-26
• Study First Posted: 2008-03-28
• Primary Completion: 2010-10
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-02
• Disposition First Submitted QC: 2013-01-02
• Disposition First Posted: 2013-01-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

• History T2DM
• Moderate or Severe Renal Impairment

Exclusion Criteria

• Glucose > 270 mg/dL (>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Vildagliptin	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment	24 weeks

Secondary Outcome Measures

Name	Time	Method
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.	24 weeks
To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.	24 weeks