Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (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: September 29, 2015
Last verified: September 2015
  Purpose
The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 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 omarigliptin 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: Omarigliptin
Drug: Sitagliptin
Drug: Placebo to omarigliptin
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) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).

  • Percentage of Participants Who Experienced at Least One Adverse Event During Phase A [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

  • Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A) → Omarigliptin (Phase B) and placebo (Phase A) → Omarigliptin (Phase B) group defined as the open-label extension period only.

  • Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

  • Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A) → Omarigliptin (Phase B) and placebo (Phase A) → Omarigliptin (Phase B) group defined as the open-label extension period only.


Secondary Outcome Measures:
  • Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.

  • Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).


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: Omarigliptin 25 mg (Phase A+B)
Omarigliptin 25 mg administered orally once weekly and matching placebo to sitagliptin administered orally once daily for 24 weeks (Phase A), followed by omarigliptin 25 mg administered orally once weekly for 28 weeks (Phase B).
Drug: Omarigliptin
Omarigliptin (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 (Phase A) → Omarigliptin (Phase B)
Sitagliptin 50 mg administered orally once daily and matching placebo to omarigliptin administered orally once weekly for 24 weeks (Phase A), followed by omarigliptin 25 mg administered orally once weekly for 28 weeks (Phase B).
Drug: Omarigliptin
Omarigliptin (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 omarigliptin
Matching placebo to omarigliptin 25 mg capsule administered orally once weekly
Placebo Comparator: Placebo (Phase A) → Omarigliptin (Phase B)
Matching placebo to omarigliptin administered orally once weekly and matching placebo to sitagliptin administered orally once daily for 24 weeks (Phase A), followed by omarigliptin 25 mg administered orally once weekly for 28 weeks (Phase B).
Drug: Omarigliptin
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
Drug: Placebo to omarigliptin
Matching placebo to omarigliptin 25 mg capsule administered orally once weekly
Drug: Placebo to sitagliptin
Matching placebo to sitagliptin 50 mg tablet administered orally once daily

Detailed Description:
The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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, omarigliptin 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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703221

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

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
Results First Received: September 29, 2015
Last Updated: September 29, 2015
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 Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
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 July 27, 2016