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)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01682759 |
|
Recruitment Status :
Completed
First Posted : September 11, 2012
Results First Posted : February 5, 2016
Last Update Posted : September 7, 2018
|
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: Omarigliptin Drug: Placebo to Omarigliptin Drug: Glimepiride Drug: Glimepiride Placebo Drug: Metformin Drug: Insulin Glargine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 751 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | September 10, 2012 |
| Actual Primary Completion Date : | January 26, 2015 |
| Actual Study Completion Date : | January 26, 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Omarigliptin
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 Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial. Drug: Insulin Glargine 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. |
|
Active Comparator: Glimepiride
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 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.
Other Names:
Drug: Metformin Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial. Drug: Insulin Glargine 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 Measures :
- Change From Baseline in Hemoglobin A1C at Week 54 [ Time Frame: Baseline and 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 [ Time Frame: Up to Week 57 ]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 [ Time Frame: Up to Week 54 ]
Secondary Outcome Measures :
- Change From Baseline in Fasting Plasma Glucose at Week 54 [ Time Frame: Baseline and 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 [ Time Frame: 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 [ Time Frame: Up to Week 54 ]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 [ Time Frame: Baseline and Week 54 ]
- Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54 [ Time Frame: Week 54 ]The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682759
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme Corp. |
Publications of Results:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT01682759 |
| Other Study ID Numbers: |
3102-016 MK-3102-016 ( Other Identifier: protocol number ) |
| First Posted: | September 11, 2012 Key Record Dates |
| Results First Posted: | February 5, 2016 |
| Last Update Posted: | September 7, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf |
| URL: | http://engagezone.msd.com/ds_documentation.php |
Keywords provided by Merck Sharp & Dohme Corp.:
|
diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Insulin Glargine |
Glimepiride Hypoglycemic Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors |