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

Novartis Pharmaceuticals527 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 the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

527

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Not previously treated with oral antidiabetic agents as defined by the protocol * Blood glucose criteria must be met * Body mass index (BMI) in the range 22-45 Exclusion Criteria: * Pregnancy or lactation * Type 1 diabetes * Evidence of serious diabetic complications * Evidence of serious cardiovascular 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 at 24 weeks

Secondary Outcomes

Change from baseline in fasting plasma glucose at 24 weeks

Adverse event profile after 24 weeks of treatment

Patients with endpoint HbA1c <7% after 24 weeks

Patients with endpoint HbA1C <6.5% after 24 weeks

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

Data from ClinicalTrials.gov

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