A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Novartis0 sites525 target enrollmentMarch 2005

ConditionsDiabetes Mellitus, Type 2

InterventionsVildagliptin Placebo

DrugsVildagliptin Placebo

Overview

Phase: Phase 3
Intervention: Vildagliptin
Conditions: Diabetes Mellitus, Type 2
Sponsor: Novartis
Enrollment: 525
Primary Endpoint: To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

October 2010

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

1

Intervention: Vildagliptin

2

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 24 weeks

Secondary Outcomes

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)