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

Use our guide to learn which trials are right for you!

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
We found this trial at
162
sites
?
mi
from
Inglewood, CA
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Bartlett, TN
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
?
mi
from
Boynton Beach, FL
Click here to add this to my saved trials
?
mi
from
Bridgewater, NJ
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Canal Fulton, OH
Click here to add this to my saved trials
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Collierville, TN
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Council Bluffs, IA
Click here to add this to my saved trials
?
mi
from
Covington, LA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Downingtown, Pennsylvania 19335
?
mi
from
Downingtown, PA
Click here to add this to my saved trials
?
mi
from
East Greenhich, RI
Click here to add this to my saved trials
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
?
mi
from
Encinitas, CA
Click here to add this to my saved trials
?
mi
from
Fayetteville, TN
Click here to add this to my saved trials
Fernandina Beach, Florida 32034
?
mi
from
Fernandina Beach, FL
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Franklin, IN
Click here to add this to my saved trials
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
?
mi
from
Gallipolis, OH
Click here to add this to my saved trials
?
mi
from
Gilbert, AZ
Click here to add this to my saved trials
?
mi
from
Glenn Dale, MD
Click here to add this to my saved trials
?
mi
from
Greenfield, IN
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
Hallandale Beach, Florida 33009
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Hopewell Junction, New York 12533
?
mi
from
Hopewell Junction, NY
Click here to add this to my saved trials
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Park, California 90255
?
mi
from
Huntington Park, CA
Click here to add this to my saved trials
Huntington Park, California 90255
?
mi
from
Huntington Park, CA
Click here to add this to my saved trials
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lake Clarke Shores, Florida 33406
?
mi
from
Lake Clarke Shores, FL
Click here to add this to my saved trials
?
mi
from
Lenoir, NC
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Lodi, NJ
Click here to add this to my saved trials
?
mi
from
Lomita, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Lynn Haven, FL
Click here to add this to my saved trials
?
mi
from
Manassas, VA
Click here to add this to my saved trials
?
mi
from
Manning, SC
Click here to add this to my saved trials
?
mi
from
Marion, OH
Click here to add this to my saved trials
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
McKinney, TX
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
?
mi
from
Monroe, LA
Click here to add this to my saved trials
?
mi
from
Muncie, IN
Click here to add this to my saved trials
?
mi
from
Nashua, NH
Click here to add this to my saved trials
?
mi
from
Natchitoches, LA
Click here to add this to my saved trials
?
mi
from
New Windsor, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
North Bay Village, Florida 33141
?
mi
from
North Bay Village, FL
Click here to add this to my saved trials
North Richland Hills, Texas 76180
?
mi
from
North Richland Hills, TX
Click here to add this to my saved trials
?
mi
from
Northridge, CA
Click here to add this to my saved trials