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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01703221
First received: October 5, 2012
Last updated: May 12, 2014
Last verified: May 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 ]

Enrollment: 414
Study Start Date: October 2012
Study Completion Date: April 2014
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
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: NCT01703221     History of Changes
Other Study ID Numbers: 3102-020, 132239
Study First Received: October 5, 2012
Last Updated: May 12, 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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014