Phase 3
Completed N=307
Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)
Source: ClinicalTrials.gov NCT01704261 ↗Enrolled (actual)
307
Serious AEs
2.6%
Results posted
Nov 2015
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 — -0.67; -0.06 %A1C — p=<0.001
Summary
This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1c (A1C) at Week 24 |
-0.67; -0.06 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (AE) |
57.5; 47.7 | — |
| PRIMARY Percentage of Participants Who Discontinued From the Study Due to an AE |
2.6; 2.6 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-19.6; -3.0 | <0.001 sig |
| SECONDARY Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24 |
23.8; 4.4; 10.1; 2.1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes mellitus
- Currently taking stable doses of metformin (>=1500 mg/day) and sulfonylurea
- Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of 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
- Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to study participation.
- History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
- 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.
- Is on or likely to require treatment for >=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted)
- Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
- Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
- Human immunodeficiency virus (HIV)
- New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within the past 3 months
- Poorly controlled hypertension
- History of malignancy 2 alcoholic drinks per day or >14 drinks per week, or engages in binge drinking
- Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or during the study
Data sourced from ClinicalTrials.gov (NCT01704261). 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.