MK-8835/PF-04971729 vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
Overview[ - collapse ][ - ]
| Purpose | This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1C in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride. |
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| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Ertugliflozin Drug: Glimepiride Drug: Placebo to Ertugliflozin Drug: Placebo to Glimepiride Drug: Metformin Drug: Sitagliptin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01999218 |
| First Received | November 25, 2013 |
| Last Updated | April 1, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 25, 2013 |
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| Last Updated Date | April 1, 2014 |
| Start Date | December 2013 |
| Estimated Primary Completion Date | December 2016 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | MK-8835/PF-04971729 vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002) |
|---|---|
| Official Title | A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin |
| Brief Summary | This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1C in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Ertugliflozin Oral, once daily, from Day 1 to Week 104 Other Names: MK-8835Drug: Glimepiride Oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (6 or 8 mg daily based on the local country label) or maximum tolerated dose Drug: Placebo to Ertugliflozin Matching placebo to Ertugliflozin, oral, once daily, from Day 1 to Week 104 Drug: Placebo to Glimepiride Matching placebo to Glimepiride, 0ral, once daily, from Day 1 to Week 104 Drug: Metformin The dose of metformin (≥1500 mg/day) should remain stable throughout the 104-week double-blind treatment period. Drug: Sitagliptin Open label, oral, once daily, rescue medication as required |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 1230 |
| Estimated Completion Date | December 2016 |
| Estimated Primary Completion Date | December 2015 |
| Eligibility Criteria | Inclusion Criteria: - Diagnosis of T2DM in accordance to American Diabetes Association guidelines - On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), dipeptidyl peptidase-4 (DPP-4) inhibitors, meglitinides, or alpha-glucosidase inhibitors) prior to study participation. - Body Mass Index (BMI) ≥18.0 kg/m^2 - Male or female not of reproductive potential - If a female of reproductive potential, agree to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug. Exclusion Criteria: - History or presence of type 1 diabetes mellitus or a history of ketoacidosis - History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant). - A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor - Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy - Known hypersensitivity or intolerance to metformin or glimepiride - On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (>=5% change in body weight in the last 6 months) - History of bariatric surgery less than 12 months prior to study participation - History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation - Active, obstructive uropathy or an indwelling urinary catheter - A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer - Known history of Human Immunodeficiency Virus (HIV) - Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells - A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease - Any clinically significant malabsorption condition - Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation - Previous randomization in a study with ertugliflozin - Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period - A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial - A positive urine pregnancy test - Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug - Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug - Consumption of more than 2 alcoholic drinks per day or engages in binge drinking - Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Toll Free Number 1-888-577-8839 |
| Location Countries | United States, Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01999218 |
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| Other Study ID Numbers | 8835-002 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Call for Information (Investigational Site 0019) | Spring Valley, California, United States, 91978 Recruiting |
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| Call for Information (Investigational Site 0001) | Hialeah, Florida, United States, 33012 Recruiting |
| Call for Information (Investigational Site 0013) | Miami, Florida, United States, 33135 Recruiting |
| Call for Information (Investigational Site 0002) | Miami Beach, Florida, United States, 33140-3608 Recruiting |
| Call for Information (Investigational Site 0012) | Pembroke Pines, Florida, United States, 33027 Recruiting |
| Call for Information (Investigational Site 0015) | Perrysburg, Ohio, United States, 43551 Recruiting |
| Call for Information (Investigational Site 0006) | Uniontown, Pennsylvania, United States, 15401 Recruiting |
| Call for Information (Investigational Site 0018) | Richmond, Virginia, United States, 23294 Recruiting |
| Merck Canada | Kirkland, Quebec, Canada, H9H 3L1 Contact: Medical Information Centre / Centre de l'information medicale de Merck Canada | 514-428-8600 / 1-800-567-2594Recruiting |