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

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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01717313
First received: October 26, 2012
Last updated: November 18, 2014
Last verified: November 2014

October 26, 2012
November 18, 2014
December 2012
May 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01717313 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 ]
  • Percentage of participants who achieve an A1C goal of <7% (53 mmol/mol) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve an A1C goal of <7% at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • 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 A1C at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Change from baseline in FPG at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve an A1C goal of <6.5% (48 mmol/mol) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Percentage of participants who achieve an A1C goal of <6.5% at Week 54 [ Time Frame: Baseline and Week 54 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
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)
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: MK-3102
    MK-3102 25 mg capsule administered orally once a week.
  • 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 during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. 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®
  • Experimental: MK-3102
    MK-3102 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by MK-3102 25 mg administered orally plus placebo to metformin (Phase B). Open-label metformin may be initiated as glycemic rescue therapy in Phase A, and open-label glimepiride in Phase B.
    Interventions:
    • Drug: MK-3102
    • Drug: Metformin
    • Drug: Placebo to metformin
    • Drug: Glimepiride
  • 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). Open-label metformin can be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.
    Interventions:
    • Drug: Placebo to MK-3012
    • Drug: Metformin
    • Drug: 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
300
May 2015
May 2015   (final data collection date for primary outcome measure)

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 >= 12 weeks and has an A1C of >=7% and <=10% or on stable monotherapy or low-dose combination therapy for > 12 weeks and has an A1C of >=6.5% and <=9%
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01717313
3102-011, 2012-003626-24
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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