A Study to Evaluate the Safety and Efficacy of Omarigliptin (MK-3102) Compared With Glimepiride in Participants With Type 2 Diabetes Mellitus for Whom Metformin is Inappropriate (MK-3102-027)

NCT01863667 | Terminated Phase 3 Results DMC

• 2 other identifiers: 3102-0272013-000301-23
• Study Type: interventional
• Target: 65
• 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 who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis 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

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Hemoglobin A1C (A1C) at Week 54

  A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.

  Baseline and Week 54

• Percentage of Participants Who Experienced at Least One Adverse Event

  An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

  Up to 57 weeks (including 3 weeks following the last dose of study drug)

• Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

  An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.

  Up to 54 weeks

Secondary Outcomes (5)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54

  Baseline and Week 54

• Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment

  54 weeks

• Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment

  54 weeks

• Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia

  Up to 54 weeks

• Change From Baseline in Body Weight at Week 54

  Baseline and Week 54

Study Arms (2)

Omarigliptin

EXPERIMENTAL

Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.

Drug: Omarigliptin; Drug: Glimepiride Placebo

Glimepiride

ACTIVE COMPARATOR

Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.

Drug: Glimepiride; Drug: Omarigliptin Placebo

Interventions

Omarigliptin DRUG

Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly

Omarigliptin

Glimepiride DRUG

Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal

Also known as: AMARYL®, GLIMY

Glimepiride

Omarigliptin Placebo DRUG

Matching placebo to omarigliptin capsule administered orally once weekly

Glimepiride

Glimepiride Placebo DRUG

Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal

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
• Have intolerability to metformin ≥1000 mg/day or have a contraindication to the use of metformin
• Females of reproductive potential agree to remain abstinent or use or have their partner use 2 acceptable methods of birth control

You may not qualify if:

• History of type 1 diabetes mellitus or a history of ketoacidosis or assessed by the investigator as possibly having type 1 diabetes
• Has been treated with:
• A thiazolidinedione (TZD) within 4 months of study participation, or
• A glucagon-like peptide-1 (GLP-1) receptor mimetic or agonist (such as exenatide or liraglutide) within 6 months of study participation, or
• Insulin within 12 weeks prior to study participation, or
• Dual antihyperglycemic agent (AHA) therapy within 12 weeks of study participation (4 months if a component of the dual AHA therapy was a TZD)
• Omarigliptin (MK-3102) at any time prior to study participation
• On a weight loss program and is not in the maintenance phase; 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 (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
• 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

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

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study was terminated based on business decisions only, and not due to any unexpected safety or efficacy concerns.

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: May 23, 2013
• First Posted: May 29, 2013
• Study Start: July 8, 2013
• Primary Completion: April 3, 2014
• Study Completion: April 3, 2014
• Last Updated: September 10, 2018
• Results First Posted: January 21, 2016

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share