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

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099918

CLAF237A2327

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone 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.

Enrollment: 717 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind