Completed

Omarigliptin's Safety and Efficacy in Japanese Type 2 Diabetes Patients with Inadequate Glycemic Control

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Study Aim

This study aims to evaluate the safety and effectiveness of Omarigliptin in Japanese patients with Type 2 Diabetes who have inadequate glycemic control, by measuring changes in Hemoglobin A1c levels after 24 weeks and monitoring adverse events throughout the study.

What is being tested

Omarigliptin

+ Placebo to sitagliptin

+ Omarigliptin

Drug
Who is being recruted

Diabetes Mellitus+3

+ Endocrine System Diseases

+ Metabolic Diseases

Over 20 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: August 28, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: October 24, 2012

Actual date on which the first participant was enrolled.

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.

NCT01703221
Principal SponsorMerck Sharp & Dohme LLC
Last updated: August 28, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

414 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDiabetes Mellitus, Type 2

Criteria

1 inclusion criteria required to participate
Has type 2 diabetes mellitus
2 exclusion criteria prevent from participating
History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime
History of type 1 diabetes mellitus or a history of ketoacidosis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers