Omarigliptin Add-on to Insulin in Japanese Participants With Type 2 Diabetes Mellitus (T2DM, MK-3102-039)

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 \[Phase A (double-blind period)\].

Timeline

Start

2016-10-17

Primary completion

2018-08-21

Completion

2018-08-21

Outcome

Mixed primary results

registry analysis (superiority test); Omarigliptin 25 mg vs Placebo; p <0.001; Difference in the Least Squares Means -0.90 (95% CI -1.15 to -0.66) NCT02906709 ↗

registry analysis (superiority test); Omarigliptin 25 mg vs Placebo; Difference in % vs. Placebo 7.0 (95% CI -8.4 to 21.8) NCT02906709 ↗

registry analysis (superiority test); Omarigliptin 25 mg vs Placebo; Difference in % vs. Placebo -4.1 (95% CI -12.8 to 0.4) NCT02906709 ↗

Publications

• Kadowaki T, Seino Y, Kaku K, Okamoto T, Kameya M, Sato A, Hirano T, Oshima N, Gantz I, O'Neill EA, Engel SS; Omarigliptin Study 039 Group. A randomized, placebo-controlled study to evaluate the efficacy and safety of adding omarigliptin to insulin therapy in Japanese patients with type 2 diabetes and inadequate glycaemic control. Diabetes Obes Metab. 2021 Jun;23(6):1242-1251. doi: 10.1111/dom.14331. Epub 2021 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Omarigliptin	Small molecule	25 mg	Oral
Background	Insulin	Protein / enzyme biologic	—	Subcutaneous

Indications