Overview

A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

Status:
Terminated
Trial end date:
2014-04-03
Target enrollment:
0
Participant gender:
All
Summary
This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck Sharp & Dohme Corp.
Treatments:
Glimepiride
Metformin
Criteria
Inclusion Criteria:

- Diagnosed with type 2 diabetes mellitus

- Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of
metformin

- Females of reproductive potential agree to remain abstinent or use or have their
partner use 2 acceptable methods of birth control

Exclusion Criteria:

- History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the
investigator as possibly having type 1 diabetes

- Has been treated with:

1. A thiazolidinedione (TZD) within 4 months of study participation, or

2. A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide
or liraglutide) within 6 months of study participation, or

3. Insulin within 12 weeks prior to study participation, or

4. Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation
(4 months if a component of the dual AHA therapy was a TZD)

5. Omarigliptin (MK-3102) at any time prior to study participation

- On a weight loss program and is not in the maintenance phase; has started a weight
loss medication in the past 6 months; or has undergone bariatric surgery within 12
months prior to study participation

- 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

- History of malignancy ≤5 years prior to study participation except for adequately
treated basal cell or squamous cell skin cancer, or in situ cervical cancer

- Clinically important hematological disorder (such as aplastic anemia,
myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

- Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the
trial, including 21 days following the last dose of study drug