A Study of the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-016)

NCT01682759 | Completed Phase 3 Results DMC

• 2 other identifiers: 3102-016MK-3102-016
• Study Type: interventional
• Target: 751
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in Type 2 diabetes mellitus participants with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior compared with that in participants treated with glimepiride.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Hemoglobin A1C at Week 54

  Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.

  Baseline and Week 54

• Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue

  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 57

• Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue

  Up to Week 54

Secondary Outcomes (5)

• Change From Baseline in Fasting Plasma Glucose at Week 54

  Baseline and Week 54

• Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54

  Week 54

• Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue

  Up to Week 54

• Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue

  Baseline and Week 54

• Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54

  Week 54

Study Arms (2)

Omarigliptin

EXPERIMENTAL

Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.

Drug: Omarigliptin; Drug: Glimepiride Placebo; Drug: Metformin; Drug: Insulin Glargine

Glimepiride

ACTIVE COMPARATOR

Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

Drug: Placebo to Omarigliptin; Drug: Glimepiride; Drug: Metformin; Drug: Insulin Glargine

Interventions

Omarigliptin DRUG

Omarigliptin

Placebo to Omarigliptin DRUG

Glimepiride

Glimepiride DRUG

Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.

Also known as: AMARYL®, GLIMY

Glimepiride

Glimepiride Placebo DRUG

Omarigliptin

Metformin DRUG

Participants will continue on their stable dose (\>=1500 mg/day) of open-label metformin throughout the trial.

Glimepiride; Omarigliptin

Insulin Glargine DRUG

Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.

Glimepiride; Omarigliptin

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
• On a stable dose of metformin (≥1500 mg/day) for at least 12 weeks with inadequate glycemic control
• Females of reproductive potential agree to remain abstinent or use or have their partner use acceptable methods of birth control

You may not qualify if:

• History of type 1 diabetes mellitus or a history of ketoacidosis
• Treated with any antihyperglycemic agents (AHA) therapies other than the protocol-required metformin within the prior 12 weeks of study participation or with omarigliptin at any time prior to signing informed consent
• On a weight loss program and is not in the maintenance phase or has
• started a weight loss medication in the past 6 months or has undergone bariatric surgery within 12 months prior to study participation
• 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
• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Handelsman Y, Lauring B, Gantz I, Iredale C, O'Neill EA, Wei Z, Suryawanshi S, Kaufman KD, Engel SS, Lai E. A randomized, double-blind, non-inferiority trial evaluating the efficacy and safety of omarigliptin, a once-weekly DPP-4 inhibitor, or glimepiride in patients with type 2 diabetes inadequately controlled on metformin monotherapy. Curr Med Res Opin. 2017 Oct;33(10):1861-1868. doi: 10.1080/03007995.2017.1335638. Epub 2017 Jun 28.

  PMID: 28548024 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

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; Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: September 10, 2012
• Primary Completion: January 26, 2015
• Study Completion: January 26, 2015
• Last Updated: September 7, 2018
• Results First Posted: February 5, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share