Phase 4
Completed N=184
Omarigliptin Add-on to Insulin in Japanese Participants With Type 2 Diabetes Mellitus (T2DM, MK-3102-039)
Source: ClinicalTrials.gov NCT02906709 ↗Enrolled (actual)
184
Serious AEs
5.5%
Results posted
Sep 2019
Primary outcomePrimary: Constrained Longitudinal Data Analysis of Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16 Excluding Data After Glycemic Rescue (Phase A) — -0.61; 0.29 Percent HbA1c — p=<0.001
◆ Published Evidence
Emerging
4citations · ~1 / year
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.
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)].
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Constrained Longitudinal Data Analysis of Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16 Excluding Data After Glycemic Rescue (Phase A) |
-0.61; 0.29 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced One or More Adverse Events (AE) Excluding Data After Glycemic Rescue (Phase A) |
51.2; 44.3 | — |
| PRIMARY Percentage of Participants Who Experienced One or More AE (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only]) |
84.6; 67.2 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE Excluding Data After Glycemic Rescue (Phase A) |
0.8; 4.9 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE Including Data After Glycemic Rescue (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only]) |
3.3; 0 | — |
| SECONDARY Constrained Longitudinal Data Analysis of Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 Excluding Data After Glycemic Rescue (Phase A) |
-11.6; 3.4 | 0.002 sig |
| SECONDARY Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A) |
5.8; 0.0 | 0.065 |
| SECONDARY Percentage of Participants Achieving HbA1c Goals (<6.5%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A) |
1.7; 0.0 | 0.334 |
| SECONDARY Constrained Longitudinal Data Analysis of Change From Baseline in 1,5-anhydroglucitol (1,5-AG) at Week 16 Excluding Data After Glycemic Rescue (Phase A) |
2.9; -0.2 | <0.001 sig |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 (Phase A+B) |
-0.57; -0.57 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Phase A+B) |
-11.5; -5.3 | — |
| SECONDARY Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 52 (Phase A+B) |
7.3; 8.6 | — |
| SECONDARY Percentage of Participants Achieving Hemoglobin A1c Goals (<6.5%) at Week 52 (Phase A+B) |
1.6; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Have T2DM
- Meet all of following criteria at Week -2 of pre-randomization
- On diet and exercise therapy for 6 weeks or longer, AND
- Have been on a stable dosage and administration of insulin (8 to 40 units/day) for 10 weeks or longer, AND.
- Have not been on any additional anti-hyperglycemic agent (AHAs, except for insulin monotherapy) for 8 weeks or longer, AND
- HbA1c ≥7.5% and ≤10.0%
- Fasting Plasma Glucose (FPG) ≥126 mg/dL and ≤230 mg/dL
- Have a body mass index (BMI) >18 kg/m^2 and 14 alcoholic drinks per week or engages in binge drinking
- Has donated or plans to donate blood products of >300 mL within 8 weeks or during the study
- Has received or plans to receive blood products within 12 weeks or during the study
Data sourced from ClinicalTrials.gov (NCT02906709) and the linked publication. 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.