Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy (CLMF237A1303)

Novartis

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LMF237 50/500 mg; Drug: LMF237 50/250 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01811485

CLMF237A1303

Details and patient eligibility

About

The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.

Enrollment: 171 patients

Sex: All

Ages: 20 to 74 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 of 20-35 kg/m^2

Exclusion criteria

• Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
• Significant heart diseases Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 3 patient groups, including a placebo group

LMF237 50/250 mg

Experimental group

Description:

Patients took LMF237 50/250 mg twice daily for 14 weeks

Treatment:

Drug: LMF237 50/250 mg

Drug: LMF237 50/500 mg

LMF237 50/500 mg

Experimental group

Description:

Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks

Treatment:

Drug: LMF237 50/250 mg

Placebo

Placebo Comparator group

Description:

Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks

Treatment:

Drug: Placebo