A Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016 AM2)



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/30/2013
Start Date:September 2012
End Date:January 2015
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin


This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea,
glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on
metformin monotherapy.


Inclusion Criteria:

- Diagnosed with Type 2 diabetes mellitus

- On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate
glycemic control

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

Exclusion Criteria:

- History of type 1 diabetes mellitus or a history of ketoacidosis

- Treated with any antihyperglycemic agents (AHA) therapies other than the
protocol-required metformin within the prior 12 weeks of study participation or with
MK-3102 at any time prior to signing informed consent

- On a weight loss program and is not in the maintenance phase or 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
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Greensboro, North Carolina 27401
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Greensboro, North Carolina 27405
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Redondo Beach, California 90277
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San Francisco, California 94133
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Wilmington, North Carolina 28401
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