Efficacy and Safety of Three Doses of Vildagliptin 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

NCT00120536

CLAF237A2384

Details and patient eligibility

About

The purpose of this study is to assess the long term safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo 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: 288 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Not currently on drug therapy for type 2 diabetes
• Blood glucose criteria must be met
• Body mass index (BMI) in the range 22-45

Exclusion criteria

• History of type 1 diabetes
• Evidence of significant diabetic complications
• Serious cardiovascular events within the past 6 months
• 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