Phase 3
Completed N=585
Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
Source: ClinicalTrials.gov NCT01697592 ↗Enrolled (actual)
585
Serious AEs
3.1%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A — 59.5; 53.8; 54.5; 60.0 Percentage of participants
Summary
This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A |
59.5; 53.8; 54.5; 60.0; 50.7; 60.3 | — |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study |
76.2; 75.4; 80.3; 84.6; 68.7; 56.5 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A |
0; 3.1; 0; 3.1; 0; 0 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study |
0.8; 4.6; 1.5; 6.2; 0; 1.6 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 |
-0.84; -0.68; -0.94; -0.88; -0.74; 0.09 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Has type 2 diabetes mellitus
- Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy
Exclusion Criteria
- History of type 1 diabetes mellitus or a history of ketoacidosis
- History of any of the following medications: Thiazolidinediones (TZD) (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime
Data sourced from ClinicalTrials.gov (NCT01697592). 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.