Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Gliclazide; Drug: Metformin; Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00102466

CLAF237A2338

Details and patient eligibility

About

This study is not being conducted in the United States. 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 vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Enrollment: 1,007 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• On a stable dose of metformin 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 significant diabetic complications
• Evidence of serious cardiovascular complications
• 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

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1,007 participants in 2 patient groups

Vildagliptin

Experimental group

Treatment:

Drug: Metformin

Drug: vildagliptin

Gliclazide

Active Comparator group

Treatment:

Drug: Metformin

Drug: Gliclazide