A Study of the Safety and Efficacy of Omarigliptin (MK-3102) in ≥18 and <45 Year-Old Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control (MK-3102-028)

NCT ID: NCT01814748

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-03
• Study Completion Date: 2015-09-14

Brief Summary

This study will examine the safety and efficacy of once-weekly omarigliptin in participants 18 to <45 years of age with Type 2 diabetes mellitus and inadequate glycemic control. The study hypothesis is that treatment with omarigliptin compared with placebo provides greater reduction in hemoglobin A1c (A1C) in participants after 24 weeks.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Omarigliptin 25 mg

Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Group Type: EXPERIMENTAL

Omarigliptin

Intervention Type: DRUG

Omarigliptin 25 mg capsule administered orally once weekly

Metformin

Intervention Type: DRUG

Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Placebo

Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Group Type: PLACEBO_COMPARATOR

Placebo to omarigliptin

Intervention Type: DRUG

Matching placebo to omarigliptin 25 mg capsule administered orally once weekly

Metformin

Intervention Type: DRUG

Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Interventions

Omarigliptin

Omarigliptin 25 mg capsule administered orally once weekly

Intervention Type: DRUG

Placebo to omarigliptin

Matching placebo to omarigliptin 25 mg capsule administered orally once weekly

Intervention Type: DRUG

Metformin

Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.

Intervention Type: DRUG

Other Intervention Names

MK-3102; Fortamet®; Glucophage®; Glucophage® XR; Glumetza®; Riomet®; Metgluco®; Glycoran®

Eligibility Criteria

Inclusion Criteria

• Has type 2 diabetes mellitus
• Currently not on an antihyperglycemic agent (AHA) for at least the past 12 weeks and has not been treated with omarigliptin at any time prior to study participation
• Participant is one of the following:

1. Male

2. Female who is not of reproductive potential

3. Female of reproductive potential who agrees to remain abstinent from heterosexual activity or use (or have her partner use) 2 acceptable methods of 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
• History of hypersensitivity to dipeptidyl-peptidase-4 (DPP-4) inhibitor
• Currently participating in or has participated in a clinical trial in the past 12 weeks
• Is on a weight loss program and not in the maintenance phase; 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 for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
• Is currently being treated for hyperthyroidism or is on thyroid 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 study, including 21 days following the last dose of study drug
• History of active liver disease (other than non-alcoholic hepatic steatosis) including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
• Has human immunodeficiency virus (HIV)
• Has had new or worsening coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months:

1. Acute coronary syndrome

2. Coronary artery intervention

3. Stroke or transient ischemic neurological disorder

• Has poorly controlled hypertension
• History of malignancy ≤5 years prior to study participation, except for basal cell or squamous cell skin cancer or in situ cervical cancer
• Has a hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
• Has a positive urine pregnancy test
• Pregnant or breastfeeding, or is expecting to conceive during the study, including 21 days following the last dose of 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 a phlebotomy (>300 mL) within 8 weeks of study participation, or intends to donate blood products during the study or has received, or is anticipated to receive, blood products within 12 weeks of study participation or during the study
• Has a clinically significant electrocardiogram abnormality

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Gantz I, Sokolova L, Jain L, Iredale C, O'Neill EA, Wei Z, Lam R, Suryawanshi S, Kaufman KD, Engel SS, Lai E. Use of Prohibited Medication, a Potentially Overlooked Confounder in Clinical Trials: Omarigliptin (Once-weekly DPP-4 Inhibitor) Monotherapy Trial in 18- to 45-year-olds. Clin Ther. 2017 Oct;39(10):2024-2037. doi: 10.1016/j.clinthera.2017.08.009. Epub 2017 Sep 18.

Reference Type: DERIVED

PMID: 28923291 (View on PubMed)

Other Identifiers

2012-004303-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3102-028

Identifier Type: -

Identifier Source: org_study_id