EUCTR2010-024256-28-CZ进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 270
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
- •1. Be a man or woman =18 and =80 years of age with T2DM and on metformin monotherapy at a stable protocol-specified dose (=2,000 mg/day [or =1,500 mg/day, if unable to tolerate a higher dose]) for at least 8 weeks immediately prior to screening and have an HbA1c of =7.0% and =10.5% at screening (or at Week -2, if screening measurement is more than 3 weeks before Week -2)
- •2. FPG <270 mg/dL (15 mmol/L) at Week -2.
- •Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Week -2 FPG criterion may return to the investigational site within 7 days for a one-time repeat FPG and continue in the study if the subject’s repeat FPG meets the
- •3. Fasting fingerstick glucose of =110 mg/dL (6.1 mmol/L) and <270 mg/dL (15 mmol/L)
- •performed at home (with documentation of the value in the subject's diary) or at the investigational site on Day 1
- •Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Day 1 criterion may return to the investigational site within 7 days for the assessment of a one-time repeat fingerstick glucose (performed at home or at the investigational site) and continue in the study if the subject’s repeat fingerstick glucose
- •meets the criterion.
- •4. Women must be:
- •– postmenopausal, defined as
- •>45 years of age with amenorrhea for at least 18 months, or
- •>45 years of age with amenorrhea for at least 6 months and <18 months and a serum follicle stimulating hormone (FSH) level >40 IU/mL, or
- •– surgically sterile (have had a hysterectomy, bilateral oophorectomy, or tubal ligation) or otherwise be incapable of pregnancy, or
- •– heterosexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (eg, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, and consistent with local regulations regarding use of birth control
- •methods for subjects participating in clinical trials, for the duration of their participation in the study, or
- •– not heterosexually active
- •Note: subjects who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study.
- •5. Women of childbearing potential must have a negative urine ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and baseline (predose, Day 1)
- •6. Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •7. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- •8. Adequate compliance with the run-in period study procedures, including performance of the fasting SMBG measurements (completed at least 3 or more fasting SMBG measurements per week) with appropriate diary entries, and =80% compliance (by pill count) with singleblind placebo capsules
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Diabetes-related or Metabolic
- •1. Has a history of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •2. Has repeated (ie, 2 or more over a 1-week period) FPG and/or fasting SMBG glucose measurements =270 mg/dL (15 mmol/L) during the pre-treatment phase, despite reinforcement of diet and exercise counseling
- •3. Has proliferative diabetic retinopathy for which treatment is planned during the course of the study
- •4. Has a history of 1 or more severe hypoglycemic episode within 6 months before screening
- •Note: a severe hypoglycemic episode is defined as an event that requires the help of another person.
- •5. Has history of hereditary glucose-galactose malabsorption or primary renal glucosuria
- •6. Has ongoing, inadequately controlled thyroid disorder (eg, subject has a known thyroid stimulating hormone [TSH] value that is either <0.2 or >10 mIU/L)
- •Note: subjects on thyroid hormone replacement therapy must be on stable doses for at least 6 weeks prior to Day 1
- •7. Is on either a PPAR? agonist (eg, a thiazolidinedione (TZD) [pioglitazone or rosiglitazone]), ongoing insulin therapy, another SGLT2 inhibitor, or any AHA (including agents such as colesevelam and bromocriptine that have indications in some regions for treatment of
- •T2DM) other than metformin, as specified in the study inclusion criteria, within 12 weeks before the screening visit
- •Note: subjects who have been treated with only a single dose of insulin may participate.
- •8. Has ongoing eating disorder or significant weight loss or weight gain within 12 weeks before the screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, subject report
- •Renal/Cardiovascular
- •9. Has renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant.
- •Note: subjects with a history of treated childhood renal disease, without sequelae, may participate.
- •10. Myocardial infarction, unstable angina, revascularization procedure (eg, stent or bypass graft surgery), or cerebrovascular accident within 3 months before screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease
- •11. Has findings on 12-lead ECG that would require urgent diagnostic evaluation or intervention (eg, new clinically important arrhythmia or conduction disturbance)
- •12. Uncontrolled hypertension (ie, using an average of 3 seated blood pressure readings with a diastolic blood pressure =100 mmHg or systolic blood pressure =160 mmHg) at Week -2.
- •Note: subjects may have their blood pressure lowering medication regimen adjusted and be re-evaluated to assess this criterion (on a stable regimen for at least 4 weeks before Day 1 to be eligible).
- •Gastrointestinal
- •13. Has history of hepatitis B surface antigen or hepatitis C antibody positive (unless associated with documented persistently stable/normal range aspartate aminotransferase [AST] and ALT levels), or other clinically active liver disease.
- •14. Has history of prior bariatric surgical procedure within 3 years before the screening visit.
- •Note: subjects with bariatric surgery more than 3 years prior to screening must be at a stable weight to be eligible to participate.
- •15. Estimated glomerular filtration rate (eGFR) (as determined by central laboratory)
- •<55 mL/min/1.73 m2 (or eGFR <60 mL/min/1.73 m2 if based upon res
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