A Study to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)
This study has been terminated.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: May 23, 2013
Last updated: April 29, 2014
Last verified: April 2014
This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin.
Type 2 Diabetes Mellitus
Drug: MK-3102 Placebo
Drug: Glimepiride Placebo
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||A Phase III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication
Primary Outcome Measures:
- Change from Baseline in A1C at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
- Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: 57 weeks ] [ Designated as safety issue: Yes ]
- Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from Baseline in Fasting Plasma Glucose (FPG) at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
- Percentage of Participants Achieving an A1C Goal <7.0% and <6.5% After 54 weeks of Treatment [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain after 54 Weeks of Treatment [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- Percentage of Participants with an Adverse Event of Symptomatic Hypoglycemia [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline in Body Weight at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
Participants receive an MK-3102 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
Drug: Glimepiride Placebo
Active Comparator: Glimepiride
Participants receive glimepiride tablet(s) (1 mg or 2 mg, maximum dose 6 mg/day) once daily and an MK-3102 placebo capsule once weekly, for 54 weeks.
Drug: MK-3102 Placebo
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosed with Type 2 diabetes mellitus
- Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin
- Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control
- History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes
Has been treated with:
- A thiazolidinedione (TZD) within 4 months of study participation, or
- A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or
- Insulin within 12 weeks prior to study participation, or
- Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)
- MK-3102 at any time prior to study participation
- On a weight loss program and is not in the maintenance phase; has started 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
- 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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No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 23, 2013
||April 29, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 20, 2014
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs