Clinical trial NCT01999218
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-12-16; Completion date: 2017-04-18
Enrollment: 1326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.

Detailed description:
The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.

Arms: arm 1: Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104 arm 2: Ertugliflozin 15 mg QD from Day 1 to Week 104 arm 3: Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104
Interventions: intervention 1: Ertugliflozin 5 mg intervention 2: Ertugliflozin 10 mg intervention 3: Glimerpiride intervention 4: Placebo to Ertugliflozin intervention 5: Placebo to Glimepiride intervention 6: Metformin intervention 7: Sitagliptin
Intervention descriptions: intervention 1: Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104 intervention 2: Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104. intervention 3: Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose intervention 4: Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104 intervention 5: Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104. intervention 6: Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily. intervention 7: Open label, oral, once daily, rescue medication as required.

Protocol documents:
Prot_SAP_000.pdf: 
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