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)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01841697
First received: April 24, 2013
Last updated: March 2, 2016
Last verified: March 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Omarigliptin Drug: Sitagliptin Drug: Placebo to omarigliptin Drug: Placebo to Sitagliptin Drug: Open-label Metformin Drug: Open-label Glimepiride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes Type 2
Drug Information available for:
Metformin
Metformin hydrochloride
Glimepiride
Sitagliptin
Sitagliptin phosphate
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Change From Baseline in A1C at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]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.
- Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 27 weeks (including 3-week follow-up) ] [ Designated as safety issue: Yes ]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.
- Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Change From Baseline in FPG at Week 24 [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]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.
- Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.
- Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.
| Enrollment: | 642 |
| Study Start Date: | June 2013 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Omarigliptin
Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks
Drug: Placebo to Sitagliptin
Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks
Drug: Open-label Metformin
Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
Other Names:
Drug: Open-label Glimepiride
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.
|
Drug: Sitagliptin
Sitagliptin 100 mg oral tablet once a day for 24 weeks
Drug: Placebo to omarigliptin
Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks
Drug: Open-label Metformin
Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
Other Names:
Drug: Open-label Glimepiride
Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01841697
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841697
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
More Information
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01841697 History of Changes |
| Other Study ID Numbers: | 3102-026 2013-000059-42 |
| Study First Received: | April 24, 2013 |
| Results First Received: | October 23, 2015 |
| Last Updated: | March 2, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck Sharp & Dohme Corp.:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Glimepiride Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Glimepiride Metformin Sitagliptin Phosphate Physiological Effects of Drugs Hypoglycemic Agents |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on September 23, 2016