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

Novartis Pharmaceuticals594 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 acarbose 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

594

Conditions

Diabetes Mellitus, Type 2

Interventions

vildagliptinDRUG

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 20-40 * 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 (1)

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

Change from baseline in HbA1c at 24 weeks

Secondary Outcomes

Change from baseline in HbA1c at 24 weeks for subset of Chinese patients

Overall adverse event profile after 24 weeks of treatment

Gastrointestinal side effect profiles after 24 weeks of treatment

Change from baseline in fasting plasma glucose at 24 weeks

Patients with endpoint HbA1c <7% after 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.