Phase 3
Completed N=329
A Study to Assess the Safety and Efficacy of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
Source: ClinicalTrials.gov NCT01717313 ↗Enrolled (actual)
329
Serious AEs
4.9%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population) — -0.49; -0.10 Percent — p=<0.001
Summary
The purpose of this study is to assess the safety and efficacy of omarigliptin (MK-3102), dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and exercise. The primary hypothesis is that after 24 weeks, treatment with omarigliptin compared with placebo provides greater reduction in hemoglobin A1c (A1C).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population) |
-0.49; -0.10 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) |
41.8; 50.0 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) |
2.4; 1.8 | — |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) |
54.5; 60.4 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) |
3.0; 2.4 | — |
| SECONDARY Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population) |
36.5; 16.3 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population) |
16.4; 5.0 | 0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population) |
-12.8; -2.5 | 0.036 sig |
| SECONDARY Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population) |
-25.6; -13.9 | 0.177 |
| SECONDARY Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population) |
-0.40; -0.80 | — |
| SECONDARY Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 54 (Phase A + Phase B, FAS Population) |
33.8; 43.8 | — |
| SECONDARY Percentage of Participants Who Achieve an A1C Goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population) |
14.5; 20.6 | — |
| SECONDARY Change From Baseline in FPG at Week 54 (Phase A + Phase B, FAS Population) |
-8.3; -21.1 | — |
Eligibility Criteria
Inclusion Criteria
- Has type 2 diabetes mellitus
- Participants in India must be ≤65 years of age
- Meets one of the following criteria: currently not on an antihyperglycemic agent (AHA) for >= 12 weeks and has an A1C of >=7% and 12 weeks and has an A1C of >=6.5% and 2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
- Has donated blood products or has had a phlebotomy within 8 weeks of study participation, or intends to donate blood products during the study or has received, or is anticipated to receive, blood products within 12 weeks of study participation or during the study
Data sourced from ClinicalTrials.gov (NCT01717313). 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.