Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Metformin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief summary:
This study will assess the safety, tolerability and glucose-lowering efficacy of MK-0893 in participants with type 2 diabetes mellitus. The primary hypothesis is that MK-0893 will reduce 24-hour weighted mean glucose (WMG) significantly more than placebo.

Detailed description:

Arms:
arm 1: MK-0893 40-mg q.d. (quaque die, once daily) group will receive MK-0893 40-mg tablets (after loading dose with 160 mg) and matching placebo to metformin and matching placebo to MK-0893. arm 2: MK-0893 at 120 mg q.d. group will receive MK-0893 120 mg q.d. tablets (after loading dose of 500 mg on Day 1) and matching placebo tablets to metformin and matching placebo to MK-0893 arm 3: Metformin taken orally, 500 mg tablets, Day 1 to Day 6: 500 mg b.i.d. (bis in die, twice daily), Day 7 to Day 13: 1000 mg in the morning and 500 mg in the evening, and Day 14 to Day 28: 1000 mg. b.i.d. and matching placebo to MK-0893. arm 4: Placebo tablets matching the MK-0893 and placebo tablets matching metformin.

Interventions: intervention 1: MK-0893 intervention 2: Metformin intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: 10 mg and 100 mg tablets intervention 2: 500 mg metformin tablets intervention 3: Placebo tablets matching MK-0893 intervention 4: Placebo tablets matching metformin

Protocol document: