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MK-3102 Phase III Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01697592
First received: September 28, 2012
Last updated: May 29, 2014
Last verified: May 2014

September 28, 2012
May 29, 2014
October 2012
May 2014   (final data collection date for primary outcome measure)
  • 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 experienced at least one adverse event [ Time Frame: Up to 52 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 discontinued from the study due to an adverse event [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01697592 on ClinicalTrials.gov Archive Site
Change from baseline in hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
MK-3102 Phase III Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015 AM1)
A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy

This study will examine the safety and efficacy of the addition of MK-3102 in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.

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 weekly
  • Drug: Matching placebo to MK-3102
    Matching placebo to MK-3102 25 mg capsule administered orally once weekly
  • Drug: Basal medication
    Participants continue basal medication at their pre-study dosage (dosage may be up-titrated during the study only if needed for rescue therapy). Basal medication includes any of the following: sulfonylureas (gliclazide, glibenclamide or glimepiride), glinides (nateglinide, mitiglinide or repaglinide), biguanides (metformin), thiazolidinediones (TZDs) (pioglitazone), alpha-glucosidase inhibitors (acarbose, voglibose or miglitol).
    Other Names:
    • gliclazide (Glimicron®)
    • glibenclamide (Euglucon®, Daonil®)
    • glimepiride (Amaryl®)
    • nateglinide (Starsis®, Fastic®, Starlix®)
    • mitiglinide (Glufast®)
    • repaglinide (Surepost®, Prandin®)
    • metformin (Metgluco®, Glycoran®, Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®)
    • pioglitazone (Actos®)
    • acarbose (Glucobay®, Precose®)
    • voglibose (Basen®)
    • miglitol (Seibule®, Glyset®)
  • Experimental: MK-3102
    MK-3102 25 mg administered orally once weekly for 52 weeks (24 weeks during Period A and 28 weeks during Period B). Participants continued pre-study basal medication throughout the duration of the study.
    Interventions:
    • Drug: MK-3102
    • Drug: Basal medication
  • Placebo Comparator: Placebo
    Matching placebo to MK-3102 administered orally once weekly for 24 weeks (Period A) followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Period B). Participants continued pre-study basal medication throughout the duration of the study.
    Interventions:
    • Drug: MK-3102
    • Drug: Matching placebo to MK-3102
    • Drug: Basal medication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
585
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has type 2 diabetes mellitus
  • Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of any of the following medications: TZD (for participants whose basal medication is not TZD) and/or insulin within 12 weeks prior to study participation, MK-3102 anytime
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01697592
3102-015, 132242
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

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