Status:
TERMINATED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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:
- A thiazolidinedione (TZD) within 4 months of study participation, or
- A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or
- Insulin within 12 weeks prior to study participation, or
- Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)
- 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
Key Trial Info
Start Date :
July 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2014
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01863667
Start Date
July 8 2013
End Date
April 3 2014
Last Update
September 10 2018
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