Phase 3
Completed N=414
Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)
Source: ClinicalTrials.gov NCT01703221 ↗Enrolled (actual)
414
Serious AEs
1.7%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24 — -0.66; -0.65; 0.13 Percent HbA1c — p=<0.001
Summary
The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24 |
-0.66; -0.65; 0.13 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event During Phase A |
50.0; 49.4; 65.9 | — |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study |
69.9; 47.2; 56.3 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A |
0.6; 1.2; 0 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study |
2.4; 1.2; 1.3 | — |
| SECONDARY Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24 |
-42.38; -45.24; -5.48 | <0.001 sig |
| SECONDARY Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24 |
-18.52; -20.75; -6.23 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Has type 2 diabetes mellitus
Exclusion Criteria
- History of type 1 diabetes mellitus or a history of ketoacidosis
- History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime
Data sourced from ClinicalTrials.gov (NCT01703221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.