Completed

Omarigliptin vs Sitagliptin for Type 2 Diabetes Inadequate Glycemic Control on Metformin

Study Aim

This phase 3 study aims to compare the effectiveness and safety of Omarigliptin versus Sitagliptin in treating type 2 diabetes patients who have inadequate glycemic control on Metformin, by measuring changes in A1C levels over 24 weeks and monitoring adverse events.

What is being tested

Omarigliptin

+ Placebo to Sitagliptin

+ Open-label Metformin

Drug

Who is being recruted

Nutritional and Metabolic Diseases+3

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

Over 18 Years

+24 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 2013

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Last updated: September 10, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: June 13, 2013

Actual date on which the first participant was enrolled.

This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.

NCT01841697

Principal SponsorMerck Sharp & Dohme LLC

Last updated: September 10, 2018

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

642 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 18 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

Nutritional and Metabolic DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate

Currently on a stable dose of metformin monotherapy ( >= 1500 mg per day) for at least 12 weeks prior to study participation

Male, or female who is not of reproductive potential or if of reproductive potential agrees to abstain from heterosexual activity or use (or have their partner use) acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug

Type 2 diabetes mellitus

21 exclusion criteria prevent from participating

Currently being treated for hyperthyroidism or is on thyroid hormone replacement therapy and has not been on a stable dose for at least 6 weeks

Has been treated with any antihyperglycemic agent (AHA) other than the protocol-required metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to signing informed consent

Has donated blood products or has had phlebotomy of > 300 mL within 8 weeks of study participation, or intends to donate blood products within the projected duration of the trial or has received, or is anticipated to receive, blood products within 12 weeks of study participation or within the projected duration of the trial

Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study

Show More Criteria

Study Plan

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

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants receive omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy.

Group II

Active Comparator

Participants receive sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continue pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may receive glimepiride (total daily dose of 1-6 mg) as rescue therapy.

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.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers