EUCTR2013-003582-34-RO进行中（未招募）1 期
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 - MK-8835/PF-04971729 vs. Glimepiride in T2DM Subjects on Metformin
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,326
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •At Visit 1/Screening
- •1. Have T2DM in accordance with ADA guidelines [1] and be =18 years of age on the day of signing the ICF.
- •2. Meet one of the following criteria:
- •On metformin monotherapy =1500 mg/day for =8 weeks with a Visit 1/Screening A1C =7.0% and =9.0% (=53 mmol/mol and =75 mmol/mol)
- •On metformin monotherapy =1500 mg/day for <8 weeks with a Visit 1/Screening A1C =7.0% and =9.0% (=53 mmol/mol and =75 mmol/mol)
- •On metformin monotherapy <1500 mg/day with a Visit 1/Screening A1C =7.5% and =9.5% (=58 mmol/mol and =80 mmol/mol)
- •On metformin in combination with a single allowable AHA (i.e., SUs at <50% the maximum approved dose in the local country label, DPP-4 inhibitors, meglitinides, or AGIs) with a Visit 1/Screening A1C =6.5% and =8.5% (=48 mmol/mol and =69 mmol/mol)
- •3. Have a body mass index (BMI) =18.0 kg/m2.
- •4. Have personally signed and dated the ICF indicating that he/she has been informed of all pertinent aspects of the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •5. Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •6. Meet one of the following criteria:
- •a. Subject is a male
- •b. Subject is a female not of reproductive potential defined as one who:
- •(1) Is postmenopausal (defined as at least 12 months with no menses in women =45 years of age, or
- •(2) Has had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to Visit 1/Screening
- •c. Subject is a female of reproductive potential and:
- •(1) agrees to remain abstinent from heterosexual activity (if this form of birth control is accepted by local regulatory agencies and ethics review committees as the sole method of birth control for subjects participating in clinical trials), or
- •(2) agrees to use (or have her partner use) acceptable contraception to prevent pregnancy while receiving blinded investigational product and for 14 days after the last dose of blinded investigational product. Two methods of contraception will be used to avoid pregnancy. Acceptable combinations of methods include:
- •Use of one of the following double-barrier methods: diaphragm with spermicide and a condom; cervical cap and a condom; or a contraceptive sponge and condom.
- •Use of hormonal contraception (any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent [including oral, subcutaneous, intrauterine and intramuscular agents, and cutaneous patch]) with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or IUD.
- •Use of an IUD with one of the following: condom; diaphragm with spermicide; contraceptive sponge; vasectomy; or hormonal contraception (see above).
- •Vasectomy with one of the following:
排除标准
- •At Visit 1/Screening
- •Diabetes Diagnosis and Prior Therapy Criteria
- •1. Has a history of type 1 diabetes mellitus or a history of ketoacidosis or subject assessed by the investigator as possibly having type 1 diabetes mellitus confirmed with a C-peptide <0.7 ng/mL (0.23 nmol/L).
- •Note: Only subjects assessed by the investigator as possibly having type 1 diabetes should have C-peptide measured at Visit 1/Screening.
- •2. Has a history of secondary causes of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).
- •3. Has a known hypersensitivity or intolerance to any SGLT2 inhibitor.
- •4. Has been treated with any of the following agents within 12 weeks of Visit 1/Screening or during the pre-randomization period:
- •Insulin of any type (except for short-term [i.e., =7 days] use during hospitalization and no longer required)
- •Other injectable anti-hyperglycemic agents (AHA) [e.g., pramlintide, exenatide, liraglutide]
- •Pioglitazone or rosiglitazone
- •Other SGLT2 inhibitor
- •Bromocriptine (Cycloset™)
- •Colesevelam (Welchol™)
- •Any other AHA with the exception of the protocol-approved agents
- •5. Has a known hypersensitivity or intolerance to metformin or glimepiride.
- •6. Meets any of the following criteria:
- •Subject is on a weight-loss program and is not weight-stable.
- •Subject is on a weight-loss medication (e.g., orlistat, phentermine/topiramate, lorcaserin) and is not weight-stable.
- •Subject is on other medications associated with weight changes (e.g., anti-psychotic agents) and is not weight-stable.
- •Subject has undergone bariatric surgery >12 months prior to Visit 1/Screening and is not weight-stable.
- •Subject has undergone bariatric surgery within 12 months of Visit 1/Screening.
- •Note: Weight-stable is defined as <5% change in body weight in the last 6 months.
- •Concomitant Disease of Organs and Systems
- •7. Has a history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or NYHA functional class III-IV heart failure within 3 months of Visit 1/Screening.
- •8. Has active, obstructive uropathy or an indwelling urinary catheter.
- •9. Has a history of malignancy =5 years prior to signing the ICF, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer:
- •Note (1): A subject with a history of malignancy >5 years prior to signing the ICF should have no evidence of residual or recurrent disease.
- •Note (2): A subject with any history of melanoma, leukemia, lymphoma, or renal cell carcinoma is excluded.
- •10. Has human immunodeficiency virus (HIV) as assessed by medical history.
- •Blood dyscrasias or any disorders causing hemoly
研究者
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