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

Novartis Pharmaceuticals1,092 enrolled

Overview

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide 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

TRIPLE

Enrollment

1,092

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

GliclazideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Not currently on drug therapy for type 2 diabetes * Body mass index (BMI) in the range 22-45 * Blood glucose criteria must be met Exclusion Criteria: * Pregnancy or lactation * Type 1 diabetes * Evidence of significant diabetic complications * Evidence of serious cardiovascular conditions * Laboratory value abnormalities as defined by the protocol * Other protocol-defined exclusion criteria may apply

Locations (2)

Novartis Investigative Site

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 104 weeks

Time frame: 104 weeks

Secondary Outcomes

Adverse event profile at 104 weeks

Time frame: 104 weeks

Change from baseline in fasting plasma glucose at 104 weeks

Time frame: 104 weeks

Patients with endpoint HbA1c <7% after 104 weeks

Time frame: 104 weeks

Patients with reduction in HbA1c >/= 0.7% after 104 weeks

Time frame: 104 weeks

Patients with reduction in HbA1x >/= 0.5% after 104 weeks

Time frame: 104 weeks

Data from ClinicalTrials.gov

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