A Study to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
Status: | Recruiting |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | July 2013 |
End Date: | April 2017 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Phase III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication
This trial will assess the safety and efficacy of 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.
glimepiride, in Type 2 diabetes mellitus participants who are metformin intolerant or who
have a contraindication to the use of metformin.
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. 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
- 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
We found this trial at
36
sites
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