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: March 13, 2014
Last verified: March 2014

September 7, 2012
March 13, 2014
September 2012
January 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01682759 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: 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.
  • Experimental: MK-3102
    Interventions:
    • Drug: MK-3102
    • Drug: Glimepiride Placebo
    • Drug: Metformin
    • Drug: Insulin Glargine
  • Active Comparator: Glimepiride
    Interventions:
    • Drug: MK-3102 Placebo
    • Drug: Glimepiride
    • Drug: Metformin
    • Drug: Insulin Glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
680
January 2015
January 2015   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01682759
3102-016, MK-3102-016
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP