Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

NCT01703221 | Completed Phase 3 Results DMC

• 2 other identifiers: 3102-020132239
• Study Type: interventional
• Target: 414
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (5)

• Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24

  HbA1C is blood marker used to report average blood glucose levels over 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).

  Baseline and Week 24

• Percentage of Participants Who Experienced at Least One Adverse Event During Phase A

  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.

  Up to 24 weeks

• Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study

  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.

  Up to 52 weeks

• Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A

  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.

  Up to 24 weeks

• Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study

  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.

  Up to 52 weeks

Secondary Outcomes (2)

• Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24

  Baseline and Week 24

• Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

Study Arms (3)

Omarigliptin 25 mg (Phase A+B)

EXPERIMENTAL

Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)

Drug: Omarigliptin; Drug: Placebo to sitagliptin

Sitagliptin (Phase A) switching to Omarigliptin (Phase B)

ACTIVE COMPARATOR

Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Drug: Omarigliptin; Drug: Sitagliptin; Drug: Placebo to omarigliptin

Placebo (Phase A) switching to Omarigliptin (Phase B)

PLACEBO COMPARATOR

Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Drug: Omarigliptin; Drug: Placebo to omarigliptin; Drug: Placebo to sitagliptin

Interventions

Omarigliptin DRUG

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Omarigliptin 25 mg (Phase A+B); Placebo (Phase A) switching to Omarigliptin (Phase B); Sitagliptin (Phase A) switching to Omarigliptin (Phase B)

Sitagliptin DRUG

Sitagliptin 50 mg tablet administered orally once daily

Also known as: Januvia®

Sitagliptin (Phase A) switching to Omarigliptin (Phase B)

Placebo to omarigliptin DRUG

Placebo to omarigliptin 25 mg capsule administered orally once weekly

Placebo (Phase A) switching to Omarigliptin (Phase B); Sitagliptin (Phase A) switching to Omarigliptin (Phase B)

Placebo to sitagliptin DRUG

Placebo to sitagliptin 50 mg tablet administered orally once daily

Omarigliptin 25 mg (Phase A+B); Placebo (Phase A) switching to Omarigliptin (Phase B)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has type 2 diabetes mellitus

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Gantz I, Okamoto T, Ito Y, Okuyama K, O'Neill EA, Kaufman KD, Engel SS, Lai E; the Omarigliptin Study 020 Group. A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1602-1609. doi: 10.1111/dom.12988. Epub 2017 Jul 6.

  PMID: 28449368 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2012
• First Posted: October 10, 2012
• Study Start: October 24, 2012
• Primary Completion: April 25, 2014
• Study Completion: April 25, 2014
• Last Updated: August 28, 2019
• Results First Posted: October 29, 2015

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share