Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)

NCT01704261 | Completed Phase 3 Results DMC

• 2 other identifiers: 3102-0222012-002612-10
• Study Type: interventional
• Target: 307
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Hemoglobin A1c (A1C) at Week 24

  A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.

  Baseline and Week 24

• Percentage of Participants Who Experienced at Least One Adverse Event (AE)

  An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

  Up to Week 27

• Percentage of Participants Who Discontinued From the Study Due to an AE

  An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.

  Up to Week 24

Secondary Outcomes (2)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline and Week 24

• Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24

  24 weeks

Study Arms (2)

Omarigliptin

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).

Drug: Omarigliptin; Drug: Glimepiride; Drug: Metformin

Placebo

PLACEBO COMPARATOR

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).

Drug: Matching placebo to Omarigliptin; Drug: Glimepiride; Drug: Metformin

Interventions

Omarigliptin DRUG

Omarigliptin 25 mg capsule administered orally once a week

Omarigliptin

Matching placebo to Omarigliptin DRUG

Matching placebo to omarigliptin capsule administered orally once a week

Placebo

Glimepiride DRUG

Open-label glimepiride tablet(s) administered orally once daily for a total daily dose \>=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.

Also known as: Amaryl®, Glimy

Omarigliptin; Placebo

Metformin DRUG

Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose \>=1500 mg

Also known as: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®

Omarigliptin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus
• Currently taking stable doses of metformin (\>=1500 mg/day) and sulfonylurea
• 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

You may not qualify if:

• History of type 1 diabetes mellitus or a history of ketoacidosis
• Treated with any antihyperglycemic agent therapies other than the protocol-required sulfonylurea and metformin within 12 weeks prior to study participation or with omarigliptin at any time prior to study participation.
• History of hypersensitivity to a dipeptidyl peptidase IV (DPP-4) inhibitor
• 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.
• Is on or likely to require treatment for \>=2 consecutive weeks or repeated courses of corticosteroids (inhaled, nasal or topical corticosteroids are permitted)
• Currently being treated for hyperthyroidism or is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks
• Medical 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
• Human immunodeficiency virus (HIV)
• New or worsening coronary heart disease, congestive heart failure, myocardial infarction, unstable angina, coronary artery intervention, stroke, or transient ischemic neurological disorder within 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
• Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
• Pregnant or breast feeding, or is expecting to conceive or donate eggs during the trial, including 21 days following the last dose of study drug
• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Lee SH, Gantz I, Round E, Latham M, O'Neill EA, Ceesay P, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, placebo-controlled clinical trial evaluating the safety and efficacy of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus inadequately controlled by glimepiride and metformin. BMC Endocr Disord. 2017 Nov 6;17(1):70. doi: 10.1186/s12902-017-0219-x.

  PMID: 29110647 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

2-(2,5-difluorophenyl)-5-(2-(methylsulfonyl)-2,6-dihydropyrrolo(3,4-c)pyrazol-5(4H)-yl)tetrahydro-2H-pyran-3-amine; glimepiride; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director, MD

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: October 18, 2012
• Primary Completion: December 23, 2014
• Study Completion: December 23, 2014
• Last Updated: September 10, 2018
• Results First Posted: November 25, 2015

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share