A Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Participants With Type 2 Diabetes Mellitus (MK-3102-018)



Status:Recruiting
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:40 - Any
Updated:11/8/2014
Start Date:October 2012
End Date:December 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment With MK-3102 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the cardiovascular (CV) safety profile of MK-3102
in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that
treatment with MK-3102 25 mg once weekly is non-inferior to treatment with placebo and
active comparators across the MK-3102 program with regard to the risk of developing a
confirmed event in the primary CV composite endpoint.


Inclusion Criteria:

- Diagnosed with type 2 diabetes mellitus

- Is on one of the following diabetes treatment regimens that is stable for at least 12
weeks (except for pioglitazone for at least 16 weeks) and is within the associated
A1C range for that treatment regimen:

1. A1C >= 6.5% and <= 10.0% (>=48 mmol/mol and <=86 mmol/mol) on: (a) diet or
exercise alone (not on antihyperglycemic agent [AHA] for >= 12 weeks) OR (b)
monotherapy with metformin (MF), pioglitazone (PIO) or an alpha-glucosidase
inhibitor (AGI) or a sodium-glucose cotransporter inhibitor (SGLT2i) OR (c) dual
combination therapy with MF, PIO, AGI or SGLT2i OR

2. A1C >= 7.0% and <=10.0% (>=53 mmol/mol and <=86 mmol/mol) on (a) monotherapy
with a sulfonylurea or meglitinide OR (b) dual combination therapy with a
sulfonylurea or a meglitinide and MF, PIO, AGI, or SGLT2i OR

3. A1C >=7.0% and <=10.0% (>=53 mmol/mol and <=86 mmol/mol) on one of the following
insulin regimens (with or without metformin): (a) basal insulin (e.g.; insulin
glargine, insulin detemir, NPH insulin, degludec) OR (b) prandial insulin (e.g.
regular, aspart, lispro, glulisine) OR (c) basal/prandial insulin regimen
consisting of multiple dose insulin injections of basal and prandial insulin or
the use of pre-mixed insulin (e.g., Novolog 70/30®, Novolin 70/30®, Humalog
75/25®, or Humulin 70/30®

- Pre-existing vascular disease (coronary artery disease, ischemic cerebrovascular
disease, atherosclerotic peripheral artery disease)

- (1) Male; (2) female not of reproductive potential; or (3) female of reproductive
potential who agrees to remain abstinent or use alone or in conjunction with their
partner 2 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

- Treated with rosiglitazone, a dipeptidyl peptidase-IV (DPP-4) inhibitor, or a
glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to study
participation or previously treated with MK-3102

- 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

- 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) as assessed by medical history

- 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
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