A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003)
Overview[ - collapse ][ - ]
| Purpose | This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the treatment of subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase B). The primary hypothesis of the trial is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for 15 mg ertugliflozin is greater than that for placebo. |
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| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: Ertugliflozin (5 mg) Drug: Ertugliflozin (10 mg) Drug: Placebo to Ertuglifozin Drug: Metformin Drug: Placebo to Metformin |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme Corp. |
| Responsible Party | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier | NCT01958671 |
| First Received | October 7, 2013 |
| Last Updated | April 24, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 7, 2013 |
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| Last Updated Date | April 24, 2014 |
| Start Date | October 2013 |
| Estimated Primary Completion Date | March 2016 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003) |
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| Official Title | A Phase 3, Randomized, Double-blind, Placebo-controlled, 26-week Multicenter Study With a 26-Week Extension to Evaluate the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise |
| Brief Summary | This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the treatment of subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase B). The primary hypothesis of the trial is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for 15 mg ertugliflozin is greater than that for placebo. |
| 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 (5 mg) One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B). Other Names:
One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B). Other Names:
One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B). Drug: Metformin 500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening ) for 2 weeks and 1000 mg (2 tablets 500 mg ) in the morning and 1000 mg (2 tablets 500 mg) in the evening thereafter. Drug: Placebo to Metformin Placebo matching metformin. Other Names: Glucophage XR, Carbophage SR, Riomet, Fortamet, Glumetza, Obimet, Gluformin, Dianben, Diabex, Diaformin, Siofor and Metfogamma. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 450 |
| Estimated Completion Date | March 2016 |
| Estimated Primary Completion Date | August 2015 |
| Eligibility Criteria | Inclusion Criteria: - Diagnosis of T2DM in accordance to American Diabetes Association guidelines - Participants with no prior allowable oral anti-hyperglycemic agents (AHA) for at least 8 weeks prior to study participation or participants on a single allowable oral AHA at the start of study participation - Particpants on a single allowable AHA must be willing to discontinue this medication at the Screening Visit (S2) and remain off this medication for the duration of the trial. Allowable oral AHAs for discontinuation are metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides or alpha-glucosidase inhibitors. Exclusion Criteria: - 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 clinically significant electrocardiogram abnormality - 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 - A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor or metformin - On a blood pressure or lipid altering medication that have not been on a stable dose for at least 4 weeks prior to study participation - A surgical procedure within 4 weeks prior to study participation or planned major surgery during the trial - 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 - Pregnant or breast-feeding, or is expecting to conceive during the trial, including 14 days following the last dose of study drug |
| 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 | NCT01958671 |
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| Other Study ID Numbers | 8835-003 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Merck Sharp & Dohme Corp. |
| Study Sponsor | Merck Sharp & Dohme Corp. |
| Collaborators | Pfizer |
| Investigators | Not Provided |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Call for Information (Investigational Site 1086) | Phoenix, Arizona, United States, 85018 Recruiting |
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| Call for Information (Investigational Site 1082) | Los Angeles, California, United States, 90022 Recruiting |
| Call for Information (Investigational Site 1043) | Hallandale Beach, Florida, United States, 33009 Recruiting |
| Call for Information (Investigational Site 1087) | Margate, Florida, United States, 33063 Recruiting |
| Call for Information (Investigational Site 1090) | Miami, Florida, United States, 33015 Recruiting |
| Call for Information (Investigational Site 1079) | Orlando, Florida, United States, 32804 Recruiting |
| Call for Information (Investigational Site 1042) | Ormond Beach, Florida, United States, 32174 Recruiting |
| Call for Information (Investigational Site 1041) | Lenoir, North Carolina, United States, 28645 Recruiting |
| Call for Information (Investigational Site 1035) | Marion, Ohio, United States, 43302 Recruiting |
| Call for Information (Investigational Site 1091) | Oklahoma City, Oklahoma, United States, 73104 Recruiting |
| Call for Information (Investigational Site 1096) | Kingsport, Tennessee, United States, 37660 Recruiting |
| Call for Information (Investigational Site 1089) | Houston, Texas, United States, 77004 Recruiting |
| Call for Information (Investigational Site 1085) | Houston, Texas, United States, 77036 Recruiting |
| Call for Information (Investigational Site 1078) | Schertz, Texas, United States, 78154 Recruiting |
| Call for Information (Investigational Site 1083) | Henrico, Virginia, United States, 23233 Recruiting |
| Call for Information (Investigational Site 1037) | Walla Walla, Washington, United States, 99362 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 |