Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: vildagliptin; Drug: thiazolidinedione (TZD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396227

CLAF237A23119

Details and patient eligibility

About

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Enrollment: 2,665 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
• Agreement to maintain the same dose of metformin from screening to the end of the study
• Age in the range of 18-80 years
• Body mass index (BMI) in the range of 22-40 kg/m2
• HbA1c in the range of 7.0 to 10%
• FPG <270 mg/dL (15 mmol/L)

Exclusion criteria

• A history of type 1 diabetes
• Liver disease
• Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,665 participants in 2 patient groups

1

Experimental group

Description:

Vildagliptin 100mg + Met

Treatment:

Drug: vildagliptin

TZD

Active Comparator group

Description:

TZD + metformin

Treatment:

Drug: thiazolidinedione (TZD)