Back to resultsA 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)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omarigliptin
Placebo to Omarigliptin
Glimepiride
Glimepiride Placebo
Metformin
Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Omarigliptin
Glimepiride
Arm Description
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
Secondary Outcome Measures
Change From Baseline in Fasting Plasma Glucose at Week 54
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).
Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).
Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.
Full Information
NCT ID
NCT01682759
First Posted
September 7, 2012
Last Updated
August 8, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01682759
Brief Title
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)
Official Title
A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 10, 2012 (Actual)
Primary Completion Date
January 26, 2015 (Actual)
Study Completion Date
January 26, 2015 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
751 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omarigliptin
Arm Type
Experimental
Arm Description
Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
Intervention Type
Drug
Intervention Name(s)
Omarigliptin
Intervention Type
Drug
Intervention Name(s)
Placebo to Omarigliptin
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Other Intervention Name(s)
AMARYL®, GLIMY
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Glimepiride Placebo
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1C at Week 54
Description
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.
Time Frame
Baseline and Week 54
Title
Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
Description
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.
Time Frame
Up to Week 57
Title
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
Time Frame
Up to Week 54
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose at Week 54
Description
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).
Time Frame
Baseline and Week 54
Title
Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
Description
The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.
Time Frame
Week 54
Title
Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
Description
Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).
Time Frame
Up to Week 54
Title
Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
Time Frame
Baseline and Week 54
Title
Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
Description
The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.
Time Frame
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
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
Exclusion Criteria:
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
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
Citations:
PubMed Identifier
28548024
Citation
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.
Results Reference
result
Learn more about this trial
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)
We'll reach out to this number within 24 hrs