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

Novartis525 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

525

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (12)

Unnamed facility

Buenos Aires, Argentina

Unnamed facility

Heidelberg Heights, Australia

Unnamed facility

Winnipeg, Canada

Unnamed facility

Cartago, Costa Rica

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 assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.

Time frame: 24 weeks

To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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