Completed

Omarigliptin Addition for Improved Glycemic Control in Type 2 Diabetes Mellitus on Metformin and Glimepiride

Study Aim

This study aims to evaluate the effectiveness of adding Omarigliptin to Metformin and Glimepiride in improving blood sugar control for individuals with Type 2 Diabetes Mellitus, by measuring changes in Hemoglobin A1c levels over 24 weeks and monitoring any adverse events.

What is being tested

Omarigliptin

+ Glimepiride

+ Metformin

Drug

Who is being recruted

Diabetes Mellitus+3

+ Endocrine System Diseases

+ Metabolic Diseases

Over 18 Years

+18 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: September 10, 2018

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

Study start date: October 18, 2012

Actual date on which the first participant was enrolled.

This study will examine the safety and efficacy of the addition of omarigliptin in participants with type 2 diabetes mellitus with inadequate glycemic control on metformin and glimepiride. The primary hypothesis is that after 24 weeks, the addition of treatment with omarigliptin provides a greater reduction in hemoglobin A1c (A1C) compared with the addition of placebo.

NCT01704261

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

307 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

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

Criteria

3 inclusion criteria required to participate

Currently taking stable doses of metformin ( >= 1500 mg/day) and sulfonylurea

Diagnosed with type 2 diabetes mellitus

Male, or female not of reproductive potential or female of reproductive potential who agrees to remain abstinent or use (or have their partner use) 2 methods of acceptable contraception to prevent pregnancy during the study and for 21 days after the last dose of study drug

15 exclusion criteria prevent from participating

Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

Current user of recreational or illicit drugs or has had a recent history of drug abuse or routinely consumes > 2 alcoholic drinks per day or > 14 drinks per week, or engages in binge drinking

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

Donated blood products within 8 weeks of study participation, or intends to donate blood products during the study or has received or anticipates receiving blood products within 12 weeks prior to study participation or 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

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Omarigliptin (MK-3102) 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

Group II

Placebo

Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

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