Phase 3
Completed N=402
A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)
Source: ClinicalTrials.gov NCT01755156 ↗Enrolled (actual)
402
Serious AEs
5.6%
Results posted
Mar 2017
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A) — -0.54; 0.00 Percent — p=<0.001
Summary
The purpose of this study is to assess the safety and efficacy of omarigliptin compared to placebo in participants with inadequate glycemic control on metformin monotherapy. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides greater reduction in hemoglobin A1c (A1C) than placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A) |
-0.54; 0.00 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B) |
65.7; 65.2 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B) |
2.0; 4.5 | — |
| PRIMARY Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B) |
21.9; 17.4 | — |
| SECONDARY Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A) |
-26.8; -12.2 | 0.011 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A) |
-10.7; -1.2 | 0.010 sig |
| SECONDARY Change From Baseline in A1C at Week 104 (Phase A+B) |
-0.42; -0.51 | — |
| SECONDARY Change From Baseline in FPG at Week 104 (Phase A+B) |
-7.8; -18.2 | — |
| SECONDARY Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A) |
38.0; 18.8 | <0.001 sig |
| SECONDARY Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A) |
10.6; 6.4 | 0.164 |
| SECONDARY Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B) |
32.2; 39.0 | — |
| SECONDARY Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B) |
13.7; 17.9 | — |
| SECONDARY Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A) |
-46.4; -18.6 | 0.001 sig |
| SECONDARY Change From Baseline in Fasting Insulin at Week 24 (Phase A) |
1.8; -1.9 | 0.025 sig |
| SECONDARY Change From Baseline in Fasting Insulin at Week 104 (Phase A+B) |
1.2; 1.8 | — |
| SECONDARY Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A) |
8.5; 9.7 | 0.654 |
| SECONDARY Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B) |
20.2; 16.2 | — |
| SECONDARY Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A) |
8.0; 9.0 | — |
| SECONDARY Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B) |
17.4; 13.9 | — |
Eligibility Criteria
Inclusion Criteria
- Has type 2 diabetes mellitus
- Currently on a stable dose of metformin monotherapy (>=1500 mg per day) for at least 12 weeks prior to study participation
- Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug
Exclusion Criteria
- History of type 1 diabetes mellitus or a history of ketoacidosis
- Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to signing informed consent
- History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
- History of intolerance, hypersensitivity, or any other contraindication to metformin, glimepiride, or insulin glargine
- Is on a weight loss program and is not in the maintenance phase or has been on a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
- Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
- Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
- Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks
- Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days after the last dose of blinded study medication
- History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
- Human immunodeficiency virus (HIV)
- New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke, or transient ischemic attacks in the past 3 months
- Poorly controlled hypertension
- History of malignancy 2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
- Has donated blood products or has had phlebotomy of >300 mL within 8 weeks of study participation, or intends to donate blood products within the projected duration of the trial or has received, or is anticipated to receive, blood products within 12 weeks of study participation or within the projected duration of the trial
Data sourced from ClinicalTrials.gov (NCT01755156). 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.