A Study to Assess the Safety and Efficacy of MK-3102 in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011)
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | December 2012 |
End Date: | April 2015 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Multicenter, Phase III, Randomized, Placebo-controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
The purpose of this study is to assess the safety and efficacy of MK-3102, dosed once-weekly
in participants with T2DM who have inadequate glycemic control on diet and exercise. The
primary hypothesis is that after 24 weeks, treatment with MK-3102 compared with placebo
provides greater reduction in hemoglobin A1c (A1C).
in participants with T2DM who have inadequate glycemic control on diet and exercise. The
primary hypothesis is that after 24 weeks, treatment with MK-3102 compared with placebo
provides greater reduction in hemoglobin A1c (A1C).
Inclusion Criteria:
- Has type 2 diabetes mellitus
- Participants in India must be ≤65 years of age
- Meets one of the following criteria: currently not on an antihyperglycemic agent
(AHA) for >= 12 weeks and has an A1C of >=7% and <=10% or on stable monotherapy or
low-dose combination therapy for > 12 weeks and has an A1C of >=6.5% and <=9%
- Participant is one of the following: male, female who is not of reproductive
potential, female of reproductive potential who agrees to remain abstinent from
heterosexual activity or use (or have their partner use) 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
- Has been treated with: a thiazolidinedione (TZD) within 4 months of study
participation, a glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist or
dipeptidyl peptidase IV (DPP-4) inhibitor within 6 months of study participation,
insulin or sodium-glucose cotransporter inhibitor within 12 weeks of study
participation, MK-3102 at any time prior to study participation
- History of hypersensitivity to DPP-4 inhibitor
- History of intolerance, hypersensitivity or any contraindication to metformin and/or
glimepiride or other sulfonylurea
- Is on a weight loss program and 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
- 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
corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
- Is currently being treated for hyperthyroidism or is on thyroid hormone 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 steatosis) including
chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic
gallbladder disease
- 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:
acute coronary syndrome, coronary artery intervention, 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
- Hematological disorder (such as aplastic anemia, myeloproliferative or
myelodysplastic syndromes, thrombocytopenia)
- 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 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
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