Conditions: Elevated Body Mass Index
Keywords: dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 181
Healthy volunteers: no

Brief summary:
A 12-week study to assess LIK066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (BMI)

Detailed description:

Arms:
arm 1: LIK066 150 mg qd within 15 minutes before starting lunch arm 2: Matching placebo tablets of LCZ696 150 mg within 15 minutes before starting lunch. arm 3: LIK066 75 mg bid before breakfast and dinner arm 4: LIK066 50 mg tid before all 3 meals; arm 5: Matching placebo tablets tid before meals.

Interventions: intervention 1: LIK066 intervention 2: Placebo
Intervention descriptions: intervention 1: LIK066 25 mg tablets intervention 2: Matching placebo tablets

Protocol document: