A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy (VERTIS-ASIA)
Abstract
This is a study to evaluate the efficacy and safety of the addition of ertugliflozin to metformin monotherapy in Asian participants with Type 2 diabetes mellitis (T2DM) who have inadequate glycemic control on metformin monotherapy. The primary hypothesis is that the mean reduction from baseline in HbA1C for 15 mg and 5 mg ertugliflozin (tested sequentially) is greater than for placebo.
Conditions: Type 2 Diabetes Mellitus.
Primary outcome: Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach); Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) (China Subpopulation); Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach); Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (China Subpopulation); Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach); Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (China Subpopulation).
Enrollment: 506 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 506 participants or records.
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