NCT01697592|CompletedPhase 3ResultsDMC

Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)

A Phase III, Multicenter, Randomized, Placebo-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of Addition of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Oral Antihyperglycemic Agent Monotherapy

Merck Sharp & Dohme LLC ClinicalTrials.gov

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2 other identifiers

3102-015132242

Study Type

interventional

Target

585

Locations

0 countries

Sites

N/A

Timeline

RegisteredOct 2012

StartedOct 2012

CompletionMay 2014

Brief Summary

This study will examine the safety and efficacy of the addition of omarigliptin in Japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

585

participants targeted

Target at P75+ for phase_3 type-2-diabetes-mellitus

Timeline

Completed

Started Oct 2012

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

September 28, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2012

Completed

22 days until next milestone

Study Start

First participant enrolled

October 24, 2012

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2014

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

October 29, 2015

Completed

Last Updated

September 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

September 28, 2012

Results QC Date

September 29, 2015

Last Update Submit

August 8, 2018

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).
Up to 24 weeks
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin 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. Glycemic rescue criteria were: fasting plasma glucose (FPG) of \>240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG \>200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.
Up to 52 weeks

Secondary Outcomes (1)

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Baseline and Week 24

Study Arms (10)

Omarigliptin 25 mg/Sulfonylureas (SUs) (Phase A+B)

EXPERIMENTAL

Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SUs throughout the duration of the study.

Drug: Omarigliptin

Omarigliptin 25 mg/Glinides (Phase A+B)

EXPERIMENTAL

Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of glinides throughout the duration of the study.

Drug: Omarigliptin

Omarigliptin 25 mg/biguanides (BGs) (Phase A+B)

EXPERIMENTAL

Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BGs throughout the duration of the study.

Drug: Omarigliptin

Omarigliptin 25 mg/Thiazolidinediones (TZDs) (Phase A+B)

EXPERIMENTAL

Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZDs throughout the duration of the study.

Drug: Omarigliptin

Omarigliptin 25 mg/α-GIs (Phase A+B)

EXPERIMENTAL

Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GIs) inhibitors throughout the duration of the study.

Drug: Omarigliptin

Placebo/SUs (Phase A) → Omarigliptin 25 mg/SUs (Phase B)

PLACEBO COMPARATOR

Placebo matching omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg is administered once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SUs throughout the duration of the study.