Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006)
Overview[ - collapse ][ - ]
Purpose | This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin. |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Ertugliflozin (5 mg) Drug: Ertugliflozin (15 mg) Drug: Placebo Drug: Metformin Drug: Sitagliptin Drug: Glimepiride Biological: Insulin |
Phase | Phase 3 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT02036515 |
First Received | January 13, 2014 |
Last Updated | April 24, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 13, 2014 |
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Last Updated Date | April 24, 2014 |
Start Date | March 2014 |
Estimated Primary Completion Date | April 2016 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Safety and Efficacy of Ertugliflozin in the Treatment of Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin (MK-8835-006) |
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Official Title | A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin |
Brief Summary | This is a safety and efficacy study of ertugliflozin (MK-8835/PF-04971729) in the treatment of participants with type 2 diabetes mellitus who have inadequate glycemic control on metformin and sitagliptin. The primary objective of the trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared with the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin. |
Detailed Description | The duration of the trial will be approximately 69 weeks. This will include a 1-week Screening Period, an up to 12-week wash-off/titration /dose-stabilization period, a 2-week single-blind, placebo run-in period, a 52-week double-blind, placebo-controlled treatment period (including a 26-week Phase A and 26-week Phase B), and a post-treatment telephone contact 14 days after the last dose of blinded investigational product. |
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 (5 mg) Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks Other Names:
Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks Other Names:
Matching placebo for ertugliflozin 5 mg, oral, and matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks Drug: Metformin Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Other Names:
Participants are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period. Other Names: JANUVIA®Drug: Glimepiride Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion Other Names: AMARYLBiological: Insulin Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 405 |
Estimated Completion Date | April 2016 |
Estimated Primary Completion Date | October 2015 |
Eligibility Criteria | Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus (T2DM) - On stable diabetes therapy of metformin with either sitagliptin or another dipeptidyl peptidase-4 (DPP-4) inhibitor or a sulfonylurea (SU) prior to study participation and is willing to wash-off/switch from another DPP-4 inhibitor/SU to sitagliptin - Body Mass Index (BMI) greater than or equal to 18.0 kg/m^2 - Male, postmenopausal female or surgically sterile female - If a female of reproductive potential, agrees 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 of type 1 diabetes mellitus or a history of ketoacidosis - History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrine disorders, drug- or chemical-induced, and post-organ transplant) - A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) or DPP-4 inhibitor - On a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable - Has undergone bariatric surgery within the past 12 months or >12 months and is not weight stable - Has been treated with insulin (except for short-term use [<= 7 days]), injectable antihyperglycemic agents (AHAs) (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other sodium-glucose co-transporter 2 (SGLT2) inhibitors, alpha glucosidase inhibitors or meglitinides, bromocriptine (Cycloset™), colesevelam (Welchol™), or any other nonapproved AHAs within 12 weeks of study participation - Has active, obstructive uropathy or indwelling urinary catheter - 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 - 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) - Has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells or any other clinically significant hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia) - A medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or active symptomatic gallbladder disease - Has any clinically significant malabsorption condition - If taking thyroid replacement therapy, has not been on a stable dose for at least 6 weeks prior to study participation - Has been previously randomized in a study with ertugliflozin - Has participated in other studies involving an investigational drug within 30 days prior or during study participation - Has undergone a surgical procedure within 6 weeks prior to or planned major surgery during study participation - Has a positive urine pregnancy test - Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of study medication - Planning to undergo hormonal therapy in preparation to donate eggs during the trial, including 14 days following the last dose of study medication - Excessive consumption of alcoholic beverages or binge drinking - Has donated 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 Toll Free Number 1-888-577-8839 |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02036515 |
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Other Study ID Numbers | 8835-006 |
Has Data Monitoring Committee | Yes |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Pfizer |
Investigators | Study Director: Medical Director Merck Sharp & Dohme Corp. |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Call for Information (Investigational Site 0030) | Lincoln, California, United States, 95648 Recruiting |
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