Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Novartis Pharmaceuticals570 enrolled

Overview

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

570

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

Metformin ComparatorDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Not currently on durg therapy for type 2 diabetes * Body mass index (BMI) in the range 22-45 * Blood glucose criteria must be met Exclusion Criteria: * Type 1 diabetes * Pregnancy or lactation * 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 investigative Site

Investigative Sites, Germany

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 52 weeks

Secondary Outcomes

Change from baseline in fasting plasma glucose at 52 weeks

Adverse event profile after 52 weeks of treatment

Change from baseline in body weight at 52 weeks

Change from baseline in fasting lipids at 52 weeks

Change from baseline in HOMA B at 52 weeks

Data from ClinicalTrials.gov

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