At a glance
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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin
In Brief
A Phase 3 clinical trial evaluating Ertugliflozin 5 mg, Ertugliflozin 15 mg, and 6 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 464 participants.
Detailed Summary
This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.
Study Details
Timeline
Interventions
Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks
Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks
Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks
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 are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.
Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion
Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.
Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks