Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01841697
First received: April 24, 2013
Last updated: August 27, 2014
Last verified: August 2014

April 24, 2013
August 27, 2014
June 2013
November 2014   (final data collection date for primary outcome measure)
  • Change from baseline in A1C at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Number of participants who experienced at least one adverse event [ Time Frame: Up to Week 27 ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued from the study due to an adverse event [ Time Frame: Up to Week 27 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01841697 on ClinicalTrials.gov Archive Site
  • Change from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Number of participants achieving an A1C goal <7.0% and < 6.5% after 24 weeks of treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)
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 Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

This is a non-inferiority study comparing MK-3102 with Sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with MK-3102 is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.

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
  • Drug: MK-3102
    MK-3102 - 25 mg capsule once a week for 24 weeks.
  • Drug: Sitagliptin
    Sitagliptin - 100 mg tablet once a day for 24 weeks
  • Drug: Placebo to MK-3102
    Placebo once a week for 24 weeks
  • Drug: Placebo to Sitagliptin
    Placebo once a day for 24 weeks
  • Drug: Open-label Metformin
    Tablet(s) total daily dose of ≥1500 mg, once or twice a day
    Other Names:
    • Fortamet®
    • Glucophage®
    • Glucophage® XR
    • Glumetza®
    • Riomet®
  • Drug: Open-label Glimepiride
    Glimepiride tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy
    Other Names:
    • Amaryl®
    • Glimy
  • Experimental: MK-3102 + metformin
    25 mg capsule once a week for 24 weeks
    Interventions:
    • Drug: MK-3102
    • Drug: Placebo to Sitagliptin
    • Drug: Open-label Metformin
    • Drug: Open-label Glimepiride
  • Active Comparator: Sitagliptin + metformin
    100 mg tablet once a day for 24 weeks
    Interventions:
    • Drug: Sitagliptin
    • Drug: Placebo to MK-3102
    • Drug: Open-label Metformin
    • Drug: Open-label Glimepiride
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
600
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Currently on a stable dose of metformin monotherapy (≥1500 mg per day) for at least 12 weeks prior to study participation
  • Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) acceptable 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
  • Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with MK-3102 at any time prior to signing informed consent
  • History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
  • Is currently participating in, or has participated in, a trial in which the participant received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial
  • History of intolerance, hypersensitivity, or any other contraindication to metformin or glimepiride
  • Is 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
  • Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
  • Is on or likely to require treatment ≥14 consecutive days or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
  • Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks
  • Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days after the last dose of trial medication
  • History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gall bladder disease
  • Human immunodeficiency virus (HIV)
  • New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke, or transient ischemic attacks in the past 3 months
  • Poorly controlled hypertension
  • 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
  • Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • Positive urine pregnancy test
  • Pregnant or breastfeeding, or is expecting to conceive during the study including 21 days following the last dose of blinded study drug
  • User of recreational or illicit drugs or has had a recent history of drug abuse
  • Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
  • Has donated blood products or has had phlebotomy of >300 mL within 8 weeks of study participation, or intends to donate blood products within the projected duration of the trial or has received, or is anticipated to receive, blood products within 12 weeks of study participation or within the projected duration of the trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01841697
3102-026, 2013-000059-42
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

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