A Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016 AM2)

Overview[ - collapse ][ - ]

Purpose This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy.
ConditionType 2 Diabetes Mellitus
InterventionDrug: MK-3102
Drug: MK-3102 Placebo
Drug: Glimepiride
Drug: Glimepiride Placebo
Drug: Metformin
Drug: Insulin Glargine
PhasePhase 3
SponsorMerck Sharp & Dohme Corp.
Responsible PartyMerck Sharp & Dohme Corp.
ClinicalTrials.gov IdentifierNCT01682759
First ReceivedSeptember 7, 2012
Last UpdatedMarch 13, 2014
Last verifiedMarch 2014

Tracking Information[ + expand ][ + ]

First Received DateSeptember 7, 2012
Last Updated DateMarch 13, 2014
Start DateSeptember 2012
Estimated Primary Completion DateJanuary 2015
Current Primary Outcome Measures
  • Change from Baseline in Hemoglobin 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: Up to Week 57] [Designated as safety issue: Yes]
  • Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [Time Frame: Up to Week 54] [Designated as safety issue: Yes]
Current Secondary Outcome Measures
  • Change from Baseline in Fasting Plasma Glucose at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]
  • Number of Participants Achieving a Hemoglobin A1C of <6.5% and <7.0% at Week 54 [Time Frame: Week 54] [Designated as safety issue: No]
  • Number of Participants with an Adverse Event of Symptomatic Hypoglycemia [Time Frame: Up to Week 54] [Designated as safety issue: Yes]
  • Change in Body Weight from Baseline at Week 54 [Time Frame: Baseline and Week 54] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Study of the Safety and Efficacy of MK-3102 Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016 AM2)
Official TitleA Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Brief Summary
This trial will assess the safety and efficacy of MK-3102 compared with the sulfonylurea,
glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on
metformin monotherapy.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: MK-3102
MK-3102 (25 mg) will be administered in a blinded manner as one capsule once a week (q.w.)
Drug: MK-3102 Placebo
Placebo matching MK-3102 (25 mg)
Drug: Glimepiride
Glimepiride (1 mg and/or 2 mg tablets).
During the double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.
Other Names:
  • AMARYL®
  • GLIMY
Drug: Glimepiride Placebo
Placebos matching glimepiride 1 mg and/or 2 mg
Drug: Metformin
Open-label
Drug: Insulin Glargine
Insulin glargine can be used for rescue therapy, if glycemic control is not maintained.
Study Arm (s)
  • Experimental: MK-3102
  • Active Comparator: Glimepiride

Recruitment Information[ + expand ][ + ]

Recruitment StatusActive, not recruiting
Estimated Enrollment680
Estimated Completion DateJanuary 2015
Estimated Primary Completion DateJanuary 2015
Eligibility Criteria
Inclusion Criteria:

- Diagnosed with Type 2 diabetes mellitus

- On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate
glycemic control

- Females of reproductive potential agree to remain abstinent or use or have their
partner use acceptable methods of birth control

Exclusion Criteria:

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

- Treated with any antihyperglycemic agents (AHA) therapies other than the
protocol-required metformin within the prior 12 weeks of study participation or with
MK-3102 at any time prior to signing informed consent

- On a weight loss program and is 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

- 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01682759
Other Study ID Numbers3102-016
Has Data Monitoring CommitteeYes
Information Provided ByMerck Sharp & Dohme Corp.
Study SponsorMerck Sharp & Dohme Corp.
CollaboratorsNot Provided
Investigators Not Provided
Verification DateMarch 2014