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A Study to Assess the Safety and Efficacy of MK-3102 in Participants With Type 2 Diabetes Mellitus (T2DM) and Inadequate Glycemic Control (MK-3102-011 AM2)

This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01717313
First received: October 26, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to assess the safety and efficacy of MK-3102, dosed once-weekly in participants with T2DM who have inadequate glycemic control on diet and exercise. The primary hypothesis is that after 24 weeks, treatment with MK-3102 compared with placebo provides greater reduction in hemoglobin A1c (A1C).


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: MK-3102
Drug: Placebo to MK-3012
Drug: Metformin
Drug: Placebo to metformin
Drug: Glimepiride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase III, Randomized, Placebo-controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1c (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 24 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experienced at least one adverse event [ Time Frame: Up to 57 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Up to 54 weeks ] [ 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 from baseline in fasting plasma glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3102
MK-3102 25 mg capsule administered orally once a week
 Drug: MK-3102
MK-3102 25 mg capsule administered orally once a week.
Drug: Metformin
If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily). Participants in the MK-3102 treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.
Other Names:
  • Fortamet®
  • Glucophage®
  • Glucophage® XR
  • Glumetza®
  • Riomet®
  • Metgluco®
  • Glycoran®
Drug: Placebo to metformin
During Phase B of the study, participants in the MK-3102 treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).
Drug: Glimepiride
If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic therapy
Other Name: Armaryl®
Placebo Comparator: Placebo to MK-3102
Placebo to MK-3102 administered orally once a week for 24 weeks (Phase A) followed by placebo to MK-3102 administered orally once a week plus metformin for an additional 30 weeks (Phase B). Metformin may be initiated as glycemic rescue therapy during Phase A of the study. Glimepiride may be initiated as glycemic rescue therapy during Phase B of the study.
 Drug: Placebo to MK-3012
Placebo to MK-3102 capsule administered orally once a week
Drug: Metformin
If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily). Participants in the MK-3102 treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.
Other Names:
  • Fortamet®
  • Glucophage®
  • Glucophage® XR
  • Glumetza®
  • Riomet®
  • Metgluco®
  • Glycoran®
Drug: Glimepiride
If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic therapy
Other Name: Armaryl®

  Eligibility

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

Inclusion Criteria:

  • Has type 2 diabetes mellitus
  • Participants in India must be ≤65 years of age

  • Meets one of the following criteria:

    • currently not on an antihyperglycemic agent (AHA) for at least the past 12 weeks
    • currently on a stable dose for >12 weeks of a single AHA or low-dose dual oral AHA combination therapy

  • Participant is one of the following:

    • Male
    • Female who is not of reproductive potential
    • Female of reproductive potential who agrees to remain abstinent 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:

    • a thiazolidinedione (TZD) within 4 months of study participation
    • a glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist or dipeptidyl peptidase IV (DPP-4) inhibitor within 6 months of study participation
    • insulin or sodium-glucose cotransporter inhibitor within 12 weeks of study participation
    • MK-3102 at any time prior to study participation
  • History of hypersensitivity to DPP-4 inhibitor
  • History of intolerance, hypersensitivity or any contraindication to metformin and/or glimepiride or other sulfonylurea
  • Is on a weight loss program and 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
  • 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 corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
  • Is currently being treated for hyperthyroidism or is on thyroid hormone 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 steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • 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:

    • acute coronary syndrome
    • coronary artery intervention
    • 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
  • Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717313

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

  Show 22 Study Locations
Sponsors and Collaborators
Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01717313     History of Changes
Other Study ID Numbers: 3102-011, 2012-003626-24
Study First Received: October 26, 2012
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013