Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 2 safety and efficacy study with ertugliflozin (PF-04971729, MK-8835) Type 2 diabetes mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 375
Healthy volunteers: no

Brief summary:
MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus. Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.

Detailed description:

Arms:
arm 1: Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days arm 2: Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 3: Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 4: Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 5: Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days arm 6: Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days

Interventions: intervention 1: Placebo to Ertugliflozin intervention 2: Ertugliflozin 1 mg intervention 3: Ertugliflozin 5 mg intervention 4: Ertugliflozin 25 mg intervention 5: Sitagliptin 100 mg intervention 6: Placebo to Sitagliptin intervention 7: Metformin
Intervention descriptions: intervention 1: Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days intervention 2: Tablet, 1 mg, once daily for 84 days intervention 3: Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days intervention 4: Tablet, 25 mg, once daily for 84 days intervention 5: Tablet, 100 mg, once daily for 84 days intervention 6: Tablet, matching placebo to 100 mg, once daily for 84 days intervention 7: Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).

Protocol document: