Efficacy and Safety of Vildagliptin in Combination With Pioglitazone 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

NCT00101803

CLAF237A2355

Details and patient eligibility

About

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of the combination of vildagliptin, an unapproved drug, and pioglitazone 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: 527 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Not previously treated with oral antidiabetic agents as defined by the protocol
• Blood glucose criteria must be met
• 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 complications
• Laboratory value abnormalities as defined by the protocol
• Known sensitivity to pioglitazone
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind