A Study of the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 44
Updated:4/13/2015
Start Date:May 2013
End Date:March 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

This study will examine the safety and efficacy of once-weekly MK-3102 in

participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic
control. The study hypothesis is that treatment with MK-3102 compared with placebo provides
greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks.


Inclusion Criteria:

- Has type 2 diabetes mellitus

- Currently not on an antihyperglycemic agent (AHA) for at least the past 12 weeks and
has not been treated with MK-3102 at any time prior to study participation

- Participant is one of the following:

1. Male

2. Female who is not of reproductive potential

3. Female of reproductive potential who agrees to remain abstinent from
heterosexual activity or use (or have her partner use) 2 acceptable methods of
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

- History of hypersensitivity to dipeptidyl-peptidase-4 (DPP-4) inhibitor

- Currently participating in or has participated in a clinical trial in the past 12
weeks

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

- Has undergone a surgical procedure within 4 weeks of study participation or has
planned major surgery during the study

- Is on or likely to require treatment for ≥14 consecutive days or repeated courses of
pharmacologic doses of corticosteroids

- Is currently being treated for hyperthyroidism or is on thyroid replacement therapy
and has not been on a stable dose for at least 6 weeks

- Is expecting to undergo hormonal therapy in preparation to donate eggs during the
study, including 21 days following the last dose of study drug

- 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

- Has human immunodeficiency virus (HIV)

- Has had new or worsening coronary heart disease or congestive heart failure within
the past 3 months, or has any of the following disorders within the past 3 months:

1. Acute coronary syndrome

2. Coronary artery intervention

3. Stroke or transient ischemic neurological disorder

- Has poorly controlled hypertension

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

- Has a hematological disorder (such as aplastic anemia, myeloproliferative or
myelodysplastic syndromes, thrombocytopenia)

- Has a positive urine pregnancy test

- Pregnant or breastfeeding, or is expecting to conceive during the study, including 21
days following the last dose of study drug

- User of recreational or illicit drugs or has had a recent history of drug abuse.
Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or
engages in binge drinking.

- Has donated blood products or has had a phlebotomy (>300 mL) within 8 weeks of study
participation, or intends to donate blood products during the study or has received,
or is anticipated to receive, blood products within 12 weeks of study participation
or during the study

- Has a clinically significant electrocardiogram abnormality
We found this trial at
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Dearborn, MI
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Greensboro, North Carolina 27401
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Manning, FL
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