Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006; VERTIS SITA2)

NCT02036515 ↗

Phase 3 Completed 464 enrolled Merck Sharp & Dohme LLC Pfizer · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2014-03-12
Primary completion: 2016-06-06
Completion: 2016-06-06

Outcome

Met primary endpoint

registry Ertugliflozin 5 mg vs Placebo; p <0.001; Difference in least squares mean -0.69 (95% CI -0.87 to -0.50) NCT02036515 ↗

registry Ertugliflozin 15 mg vs Placebo; p <0.001; Difference in least squares mean -0.76 (95% CI -0.95 to -0.58) NCT02036515 ↗

release “Phase 3 study (VERTIS SITA2) of ertugliflozin, an investigational oral SGLT2 inhibitor for the treatment of patients with type 2 diabetes, met its primary endpoint.” merck.com ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ertugliflozin	Unknown	5 mg	Oral
Subject	Ertugliflozin	Unknown	15 mg	Oral
Background	Glimepiride	Small molecule	—	Oral
Background	Metformin	Small molecule	—	Oral
Background	Sitagliptin	Small molecule	100 mg	Oral
Background	insulin glargine	Protein / enzyme biologic	—	Other