Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: metformin; Drug: vildagliptin + metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728351

CLMF237A2309

Details and patient eligibility

About

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Enrollment: 317 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of T2DM treated with Metformin

Exclusion criteria

• FPG >= 260 mg/dL (14.4mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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317 participants in 2 patient groups

vildagliptin + metformin

Experimental group

Treatment:

Drug: vildagliptin + metformin

metformin

Active Comparator group

Treatment:

Drug: metformin