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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-3102
Drug: Matching placebo to MK-3102
Drug: Basal medication
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 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change from baseline in hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Enrollment: 585
Study Start Date: October 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: MK-3102
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®)
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.
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®)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01697592     History of Changes
Other Study ID Numbers: 3102-015, 132242
Study First Received: September 28, 2012
Last Updated: May 29, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Miglitol
Nateglinide
Pioglitazone
Repaglinide
Mitiglinide
Voglibose
Glyburide
Gliclazide
Hypoglycemic Agents
Metformin
Acarbose
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 20, 2014