- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01841697
Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)
August 9, 2018 updated by: Merck Sharp & Dohme LLC
A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
642
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes mellitus
- 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
Exclusion Criteria:
- History of type 1 diabetes mellitus or a history of ketoacidosis
- 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
- History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
- Is currently participating in, or has participated in, a trial in which the participant received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial
- History of intolerance, hypersensitivity, or any other contraindication to metformin or sitagliptin
- Is on a weight loss program and is not in the maintenance phase or has been on a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
- Has undergone a surgical procedure within 4 weeks of study participation or has planned major surgery during the study
- Is on or likely to require treatment ≥14 consecutive days or repeated courses of corticosteroids (inhaled, nasal and topical corticosteroids are permitted)
- 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
- Is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days after the last dose of trial medication
- History of active liver disease (other than non-alcoholic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gall bladder disease
- Human immunodeficiency virus (HIV)
- New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, stroke, or transient ischemic attacks in the past 3 months
- Poorly controlled hypertension
- History of malignancy ≤5 years prior to study participation, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
- Positive urine pregnancy test
- Pregnant or breastfeeding, or is expecting to conceive during the study including 21 days following the last dose of blinded study drug
- User of recreational or illicit drugs or has had a recent history of drug abuse
- Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omarigliptin 25 mg once weekly
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.
|
Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks
Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks
Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
Other Names:
Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy
Other Names:
|
Active Comparator: Sitagliptin 100 mg once daily
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.
|
Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
Other Names:
Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy
Other Names:
Sitagliptin 100 mg oral tablet once a day for 24 weeks
Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in A1C at Week 24
Time Frame: Baseline and Week 24
|
A1C is a measure of the percentage of glycated hemoglobin in the blood.
Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.
|
Baseline and Week 24
|
Percentage of Participants Who Experienced at Least One Adverse Event
Time Frame: Up to 27 weeks (including 3-week follow-up)
|
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Data presented below excludes data after initiation of glycemic rescue therapy.
|
Up to 27 weeks (including 3-week follow-up)
|
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 24 weeks
|
An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.
Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Data presented below excludes data after initiation of glycemic rescue therapy.
|
Up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in FPG at Week 24
Time Frame: Baseline and Week 24
|
Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.
|
Baseline and Week 24
|
Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment
Time Frame: Week 24
|
Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.
|
Week 24
|
Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment
Time Frame: Week 24
|
Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.
|
Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 13, 2013
Primary Completion (Actual)
November 17, 2014
Study Completion (Actual)
November 17, 2014
Study Registration Dates
First Submitted
April 24, 2013
First Submitted That Met QC Criteria
April 24, 2013
First Posted (Estimate)
April 26, 2013
Study Record Updates
Last Update Posted (Actual)
September 10, 2018
Last Update Submitted That Met QC Criteria
August 9, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Metformin
- Sitagliptin Phosphate
- Glimepiride
Other Study ID Numbers
- 3102-026
- 2013-000059-42 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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