At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Trial and Subsequent Open-Label, Extension Trial to Assess the Safety and Efficacy of Addition of Omarigliptin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Monotherapy in Addition to Diet and Exercise Therapy
In Brief
A Phase 4 clinical trial evaluating Omarigliptin, Placebo, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 184 participants.
Detailed Summary
This study will examine the efficacy of omarigliptin 25 mg once weekly compared to placebo in Japanese patients with T2DM who have inadequate glycemic control on insulin monotherapy in addition to diet and exercise therapy. The primary hypothesis of the study is that omarigliptin 25 mg once weekly provides greater reduction in hemoglobin A1C (HbA1c) compared with placebo as assessed by change from baseline to Week 16 \[Phase A (double-blind period)\].
Study Details
Timeline
Interventions
Omarigliptin, 25 mg orally once weekly
Placebo to omarigliptin orally once weekly
Insulin will be administered subcutaneously during the trial as monotherapy; dosage and administration following each package insert.