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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703221
• Other study ID #: 3102-020
• Secondary ID: 132239
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2012
• Est. completion date: April 25, 2014

Study information

• Verified date: August 2019
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: April 25, 2014
• Est. primary completion date: April 25, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Omarigliptin
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
• Sitagliptin
Sitagliptin 50 mg tablet administered orally once daily
• Placebo to omarigliptin
Placebo to omarigliptin 25 mg capsule administered orally once weekly
• Placebo to sitagliptin
Placebo to sitagliptin 50 mg tablet administered orally once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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 inhib — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24	Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.	Baseline and Week 24
Secondary	Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24	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).	Baseline and Week 24