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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01682759
First received: September 7, 2012
Last updated: August 15, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-3102
Drug: MK-3102 Placebo
Drug: Glimepiride
Drug: Glimepiride Placebo
Drug: Metformin
Drug: Insulin Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

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 ]

Estimated Enrollment: 680
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3102 Drug: MK-3102
MK-3102 (25 mg) will be administered in a blinded manner as one capsule once a week (q.w.)
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.
Active Comparator: Glimepiride 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: Metformin
Open-label
Drug: Insulin Glargine
Insulin glargine can be used for rescue therapy, if glycemic control is not maintained.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01682759     History of Changes
Other Study ID Numbers: 3102-016, MK-3102-016
Study First Received: September 7, 2012
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 21, 2014