Back to resultsA 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)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omarigliptin
Glimepiride
Omarigliptin Placebo
Glimepiride Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Omarigliptin
Glimepiride
Arm Description
Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.
Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment
Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.
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
Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.
Change From Baseline in Body Weight at Week 54
Body weight was to be measured (in duplicate) using a calibrated digital scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01863667
Brief Title
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)
Official Title
A Phase III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate Due to Intolerance or Contraindication
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
July 8, 2013 (Actual)
Primary Completion Date
April 3, 2014 (Actual)
Study Completion Date
April 3, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omarigliptin
Arm Type
Experimental
Arm Description
Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Omarigliptin
Intervention Description
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Other Intervention Name(s)
AMARYL®, GLIMY
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Omarigliptin Placebo
Intervention Description
Matching placebo to omarigliptin capsule administered orally once weekly
Intervention Type
Drug
Intervention Name(s)
Glimepiride Placebo
Intervention Description
Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1C (A1C) at Week 54
Description
A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
Time Frame
Baseline and Week 54
Title
Percentage of Participants Who Experienced at Least One Adverse Event
Description
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.
Time Frame
Up to 57 weeks (including 3 weeks following the last dose of study drug)
Title
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Description
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.
Time Frame
Up to 54 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54
Description
This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.
Time Frame
Baseline and Week 54
Title
Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment
Description
Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.
Time Frame
54 weeks
Title
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
Description
Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment
Time Frame
54 weeks
Title
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia
Description
An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.
Time Frame
Up to 54 weeks
Title
Change From Baseline in Body Weight at Week 54
Description
Body weight was to be measured (in duplicate) using a calibrated digital scale.
Time Frame
Baseline and Week 54
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis Link
Available IPD/Information URL
http://www.merck.com/clinical-trials/study.html?id=3102-027&kw=3102-027&tab=access
Learn more about this trial
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)
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