Addition of MK-3102 to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022 AM4)



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:5/3/2014
Start Date:October 2012
End Date:December 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin

This study will examine the safety and efficacy of the addition of MK-3102 in participants
with type 2 diabetes mellitus with inadequate glycemic control on metformin and
sulfonylurea. The primary hypothesis is that after 24 weeks, the addition of treatment with
MK-3102 provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of
placebo.


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
MK-3102 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 <=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

- Current user of recreational or illicit drugs or has had a recent history of drug
abuse or routinely consumes >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
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