Efficacy and Safety of Three Doses of Vildagliptin in Drug Naive Patients With Type 2 Diabetes

Phase 3CompletedNCT00120536

Novartis288 enrolled

Overview

The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo 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

288

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Not currently on drug therapy for type 2 diabetes * Blood glucose criteria must be met * Body mass index (BMI) in the range 22-45 Exclusion Criteria: * History of type 1 diabetes * Evidence of significant diabetic complications * Serious cardiovascular events within the past 6 months * Laboratory value abnormalities as defined by the protocol * 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

Adverse event profile after 24 weeks of treatment

Change from baseline in fasting plasma glucose at 24 weeks

Patients with endpoint HbA1c < 7% after 24 weeks

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

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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