Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 171
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Patients took LMF237 50/250 mg twice daily for 14 weeks arm 2: Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks arm 3: Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks

Interventions: intervention 1: LMF237 50/250 mg intervention 2: LMF237 50/500 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily intervention 2: Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily intervention 3: Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily

Protocol document: