Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%

Novartis Pharmaceuticals251 enrolled

Overview

This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

251

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Blood glucose criteria must be met * Not currently on drug therapy for type 2 diabetes * 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 conditions * Laboratory value abnormalities as defined by the protocol * Other protocol-defined exclusion criteria may apply

Locations (1)

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 12 weeks

Secondary Outcomes

Adverse event profile after 12 weeks of treatment

Patients with reduction in HbA1c >/= 0.7% after 12 weeks

Change from baseline in fasting plasma glucose at 12 weeks

Change from baseline in HOMA-B at 12 weeks

Change from baseline in body weight at 12 weeks

Data from ClinicalTrials.gov

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