MK-3102 Phase III Clinical Trial - Placebo- and Sitagliptin-controlled Monotherapy Study in Japanese Participants With Type 2 Diabetes Mellitis (MK-3102-020)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01703221
First received: October 5, 2012
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to assess the efficacy of MK-3102 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of MK-3102 25 mg weekly. The primary hypotheses are that after 24 weeks 1) MK-3102 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) the mean change from baseline in HbA1c in participants treated with MK-3102 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-3102
Drug: Sitagliptin
Drug: Placebo to MK-3102
Drug: Placebo to sitagliptin
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- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline for hemoglobin A1c (HbA1c) [ 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 24 ] [ Designated as safety issue: Yes ]
  • Percentage of participants who experienced at least one adverse event [ Time Frame: Up to Week 52 ] [ 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 ]
  • Percentage of participants who discontinued from the study due to an adverse event [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline for 2-hour post meal glucose (PMG) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline for fasting plasma glucose (FPG) [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 410
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3102
MK-3102 25 mg administered orally once weekly and matching placebo to sitagliptin administered orally once daily for 24 weeks (Phase A), followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Phase B).
Drug: MK-3102
MK-3102 25 mg capsule administered orally once weekly
Drug: Placebo to sitagliptin
Matching placebo to sitagliptin 50 mg tablet administered orally once daily
Active Comparator: Sitagliptin
Sitagliptin 50 mg administered orally once daily and matching placebo to MK-3102 administered orally once weekly for 24 weeks (Phase A), followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Phase B).
Drug: MK-3102
MK-3102 25 mg capsule administered orally once weekly
Drug: Sitagliptin
Sitagliptin 50 mg tablet administered orally once daily
Other Name: Januvia®
Drug: Placebo to MK-3102
Matching placebo to MK-3102 25 mg capsule administered orally once weekly
Placebo Comparator: Placebo
Matching placebo to MK-3102 administered orally once weekly and matching placebo to sitagliptin administered orally once daily for 24 weeks (Phase A), followed by MK-3102 25 mg administered orally once weekly for 28 weeks (Phase B).
Drug: MK-3102
MK-3102 25 mg capsule administered orally once weekly
Drug: Placebo to MK-3102
Matching placebo to MK-3102 25 mg capsule administered orally once weekly
Drug: Placebo to sitagliptin
Matching placebo to sitagliptin 50 mg tablet administered orally once daily

  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

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis
  • History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, MK-3102 and/or sitagliptin anytime
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01703221     History of Changes
Other Study ID Numbers: 3102-020, 132239
Study First Received: October 5, 2012
Last Updated: January 24, 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
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014