A Study of MK-3102 in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019)



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:30 - Any
Updated:2/7/2015
Start Date:October 2012
End Date:November 2015
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects With Type 2 Diabetes Mellitus With Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycemic Control

The purpose of this study is to evaluate the efficacy and safety of MK-3102 in participants
with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end
stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of
the study is that MK-3102 compared to placebo produces greater reduction in glycosylated
hemoglobin (A1C) after 24 weeks.


Inclusion Criteria:

- Type 2 diabetes mellitus and be at least 30 years of age

- Moderate or severe chronic renal insufficiency or end stage renal disease on dialysis

- Meet one of the following criteria:

1. is currently not on an antihyperglycemic agent (AHA) and has A1C >=7% and <=10%
at screening

2. is currently on a single oral AHA or low-dose dual oral combination AHA and has
A1C >=6.5% and <=9% at screening

3. is currently on a stable insulin regimen (>= 15 U/day) for >= 10 weeks, with no
oral AHA, and has A1C >=7.5% and <=10% and FPG >130 mg/dL at screening

- (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 28
days after the last dose of study drug

Exclusion Criteria:

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

- Treated with any incretin mimetic or thiazolidinedione (TZD) within 12 weeks prior to
screening or with MK-3102 at any time prior to study participation

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

- History of intolerance or hypersensitivity to glipizide or insulin glargine or any
contraindication to glipizide or insulin glargine

- 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

- Undergone a surgical procedure within 4 weeks prior to screening or has planned major
surgery during the trial

- On or likely to require treatment for >=2 consecutive weeks or repeated courses of
corticosteroids (note: 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

- If on dialysis, does not regularly adhere to dialysis schedule

- Diagnosis of congestive heart failure with New York Heart Association (NYHA) Class IV

- 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

- Severe active peripheral vascular disease

- 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)

- Positive pregnancy test

- Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the
trial, including 28 days following the last dose of study drug

- 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 alcoholic drinks per week, or
engages in binge drinking
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