Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: pioglitazone; Drug: vildagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00138554

CLAF237A2304E1

Details and patient eligibility

About

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Enrollment: 318 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Only patients successfully completing study CLAF237A2304 are eligible
• Written informed consent
• Ability to comply with all study requirements

Exclusion criteria

• Premature discontinuation from study CLAF237A2304
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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318 participants in 2 patient groups

vildagliptin 50 mg qd + pioglitazone 45 mg qd

Experimental group

Description:

vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks

Treatment:

Drug: pioglitazone

Drug: vildagliptin

vildagliptin 50 mg bd+ pioglitazone 45 mg qd

Experimental group

Description:

vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks

Treatment:

Drug: pioglitazone

Drug: vildagliptin