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. (see Contacts and Locations)
Verified September 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: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: MK-3102
Drug: Placebo to MK-3102
Drug: Metformin
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, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3102 25 mg
MK-3102 25 mg, once weekly, for 24 weeks
Drug: MK-3102
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®
Placebo Comparator: Placebo
Placebo to MK-3102, once weekly, for 24 weeks
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®

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814748

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Florida
Call for Information (Investigational Site 0014) Recruiting
Hialeah, Florida, United States, 33012
Call for Information (Investigational Site 0003) Recruiting
Manning, Florida, United States, 29102
United States, Michigan
Call for Information (Investigational Site 0007) Recruiting
Dearborn, Michigan, United States, 48124
United States, North Carolina
Call for Information (Investigational Site 0016) Recruiting
Greensboro, North Carolina, United States, 27405
United States, Texas
Call for Information (Investigational Site 0010) Recruiting
Houston, Texas, United States, 77055
Call for Information (Investigational Site 0011) Recruiting
Houston, Texas, United States, 77043
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
Romania
Merck Sharp & Dohme Romania SRL Recruiting
Bucharest, Romania
Contact: Eran Gefen    38 (044) 393 74 80      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Maria Koroleva    7 0959410000      
Serbia
Merck Sharp & Dohme Recruiting
Belgrade, Serbia
Contact: Eran Gefen    38 (044) 393 74 80      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Ukraine
MSD Ukraine LLC Recruiting
Kiev, Ukraine
Contact: Eran Gefen    38 (044) 393 74 80      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01814748     History of Changes
Other Study ID Numbers: 3102-028
Study First Received: March 18, 2013
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Therapeutic Uses

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014