A Study of the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028 AM1)

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01814748
First received: March 18, 2013
Last updated: April 1, 2014
Last verified: April 2014

March 18, 2013
April 1, 2014
May 2013
March 2016   (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 ]
  • Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to Week 27 ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Discontinued from the Study Due to an Adverse Event [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01814748 on ClinicalTrials.gov Archive Site
  • Change from Baseline in 2-hour Post-Meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change in Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Number of Participants Attaining A1C Glycemic Goals of <7.0% and <6.5% at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Time to Participant Rescue with Open-label Metformin for Participants Exceeding Pre-specified Glycemic Thresholds [ Time Frame: Up to Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028 AM1)
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

This study will examine the safety and efficacy of once-weekly MK-3102 in

participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: MK-3102
    MK-3102 25 mg capsule administered orally once weekly
  • Drug: Placebo to MK-3102
    Matching placebo to MK-3102 25 mg capsule administered orally once weekly
  • Drug: Metformin
    Participants exceeding pre-specified glycemic thresholds during the double-blind treatment period will receive rescue therapy with open-label metformin.
    Other Names:
    • Fortamet®
    • Glucophage®
    • Glucophage® XR
    • Glumetza®
    • Riomet®
    • Metgluco®
    • Glycoran®
  • Experimental: MK-3102 25 mg
    MK-3102 25 mg, once weekly, for 24 weeks
    Interventions:
    • Drug: MK-3102
    • Drug: Metformin
  • Placebo Comparator: Placebo
    Placebo to MK-3102, once weekly, for 24 weeks
    Interventions:
    • Drug: Placebo to MK-3102
    • Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
March 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has type 2 diabetes mellitus
  • Currently not on an antihyperglycemic agent (AHA) for at least the past 12 weeks and has not been treated with MK-3102 at any time prior to study participation
  • Participant is one of the following:

    1. Male
    2. Female who is not of reproductive potential
    3. Female of reproductive potential who agrees to remain abstinent from heterosexual activity or use (or have her partner use) 2 acceptable methods of 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
  • History of hypersensitivity to dipeptidyl-peptidase-4 (DPP-4) inhibitor
  • Currently participating in or has participated in a clinical trial in the past 12 weeks
  • Is on a weight loss program and not in the maintenance phase; 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 for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
  • Is currently being treated for hyperthyroidism or is on thyroid 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 study, including 21 days following the last dose of study drug
  • 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
  • Has human immunodeficiency virus (HIV)
  • Has had new or worsening coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months:

    1. Acute coronary syndrome
    2. Coronary artery intervention
    3. Stroke or transient ischemic neurological disorder
  • Has poorly controlled hypertension
  • History of malignancy ≤5 years prior to study participation, except for basal cell or squamous cell skin cancer or in situ cervical cancer
  • Has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • Has a positive urine pregnancy test
  • Pregnant or breastfeeding, or is expecting to conceive during the study, including 21 days following the last dose of 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 a phlebotomy (>300 mL) within 8 weeks of study participation, or intends to donate blood products during the study or has received, or is anticipated to receive, blood products within 12 weeks of study participation or during the study
  • Has a clinically significant electrocardiogram abnormality
Both
18 Years to 44 Years
No
Contact: Toll Free Number 1-888-577-8839
United States,   Romania,   Russian Federation,   Serbia,   South Africa,   Ukraine
 
NCT01814748
3102-028
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

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