Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)

NCT02099110 ↗

Phase 3 Completed 1233 enrolled Merck Sharp & Dohme LLC Pfizer · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin given together or alone along with metformin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.

Timeline

Start: 2014-04-22
Primary completion: 2016-05-26
Completion: 2016-05-26

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ertugliflozin	Unknown	5 mg	Oral
Subject	Ertugliflozin	Unknown	15 mg	Oral
Subject	Sitagliptin	Small molecule	100 mg	Oral
Background	Glimepiride	Small molecule	—	Oral
Background	Metformin	Small molecule	1500 mg	Oral
Background	insulin glargine	Protein / enzyme biologic	—	Subcutaneous

Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)

Summary

Timeline

Publications

Drugs

Indications