Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Novartis Pharmaceuticals362 enrolled

Overview

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

362

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinDRUG

Vildagliptin 50 mg tablets

pioglitazoneDRUG

pioglitazone 45 mg qd

PlaceboDRUG

Vildagliptin matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Blood glucose criteria must be met * Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone * Body mass index (BMI) in the range 22-45 Exclusion Criteria: * Type 1 diabetes * Pregnancy or lactation * Evidence of serious cardiovascular complications * Evidence of serious diabetic complications * Laboratory value abnormalities as defined by the protocol * Known sensitivity to pioglitazone * Other protocol-defined exclusion criteria may apply

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Change from baseline in HbA1c after 24 weeks

Secondary Outcomes

Change from baseline in fasting plasma glucose at 24 weeks

Patients with endpoint HbA1c <7% after 24 weeks

Patients with reduction in HbA1c >/= to 0.7% after 24 weeks

Adverse event profile after 24 weeks of treatment

Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c

Data from ClinicalTrials.gov

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