Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Vildagliptin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497522

CLMF237A1301

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.

Enrollment: 183 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
• HbA1c in the range of 7.0-10.0%
• Body mass index in the range 20-35 kg/m2

Exclusion criteria

• Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
• Significant heart diseases

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

183 participants in 2 patient groups, including a placebo group

Vildagliptin

Experimental group

Description:

In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily.

Treatment:

Drug: Vildagliptin

Placebo

Placebo Comparator group

Description:

In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.

Treatment:

Drug: Placebo