EUCTR2014-001049-25-GB进行中（未招募）1 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) with Sitagliptin in the Treatment of Subjects with T2DM with Inadequate Glycemic Control on Diet and Exercise - MK-8835/PF-PF-04971729 and Sitagliptin Initial Combination Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- 性别
- All
入选标准
- •At Visit 1/Screening
- •1. Have T2DM in accordance with ADA guidelines [20] and be =18 years of age on the day of signing the ICF.
- •2. Meet one of the following criteria:
- •Not on AHA for =8 weeks with a Visit 1/Screening A1C =8.0% and =10.5% (=64 mmol/mol and =91 mmol/mol)
- •On single allowable AHA with a Visit 1/Screening A1C =7.5% and =10.0% (=58 mmol/mol and =86 mmol/mol)
- •On low-dose dual combination therapy with allowable AHAs with a Visit 1/Screening A1C =7.5% and =10.0% (=58 mmol/mol and =86 mmol/mol)
- •NOTE: Allowable AHAs prior to screening are: metformin, a-glucosidase inhibitors, sulfonylureas and glinides.
- •NOTE: low dose” defined as =50% of maximum labeled dose of an AHA.
- •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 or
- •(2) agrees to use (or have their partner use) acceptable contraception to prevent pregnancy within the projected duration of the trial 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: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; IUD; or hormonal contraception (see above).
- •At Visit 3/Week -2
- •7. A1C =8.0% and =10.5% (=64 mmol/mol and =91 mmol/mol).
- •Note: Subjects who are not on an AHA for =8 weeks at Visit 1/Screening, going directly to a combined Visit 2/3 at Week 2, will have the Visit 1/Screening A1C determination used to assess this inclusion criterion if the Visit 1/Screening A1C was obtained within 2 weeks of the combined Visit 2/3.
- •At Visit 4/Day 1
- •8. Be =80% compliant with the placebo run-in medication (as determined by site-performed pill count).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 155
- •F.1.3 Elderly (>=65 years)
排除标准
- •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 other specific types 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 or sitagliptin.
- •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 use [i.e., =7 days] during concomitant illness or other stress)
- •Other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide)
- •Pioglitazone or rosiglitazone
- •Other SGLT2 inhibitors
- •Dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitor)
- •Bromocriptine (Cycloset™)
- •Colesevelam (Welchol™)
- •Any other AHA with the exception of the protocol-approved agents
- •5. Meets the following criteria:
- •Subject is on 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
- •6. 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.
- •7. Has active, obstructive uropathy or indwelling urinary catheter
- •8. 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 informed consent should have no evidence of residual or recurrent disease.
- •Note (2) A subject with a history of melanoma, leukemia, lymphoma, or renal carcinoma is excluded.
- •9. Has human immunodeficiency virus (HIV) as assessed by medical history.
- •A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or
- •A clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
- •11. Has 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.
- •12. Has any clinically significant malabsorption condition.
- •13. Is currently being treated for hyperthyroidism
- •14. Is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks prior to Visit 1/Screening.
- •Note: Subjects who meet this criterion may be re-screened after being on a stable dose of thyroid replacemen
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