EUCTR2009-018070-64-FR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26 Week Multicenter Study with a 26-Week Extension to Evaluate the Efficacy, Safety, and Tolerability of JNJ 28431754 (Canagliflozin) Compared with Placebo in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy - The CANTATA-MP Trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Man or woman > or =18 and < or =80 years of age with T2DM who meets 1 of the following 5 criteria:
- •On dual combination metformin and pioglitazone, both agents at protocol specified doses* (stable doses for at least 16 weeks prior to screening), with an HbA1c of =7.0% and < or =10.5% at screening (or at Week -2, if screening measurement is more than 3 weeks prior to Week -2) or
- •On dual combination metformin and pioglitazone (stable doses for at least 8 weeks prior to screening), with either agent at a dose below protocol-specified*, with an HbA1c of =7.5 % and < or =11.0% at screening, and has an HbA1c of =7.0% and < or =10.5% at Week -2, after at least 8 weeks on stable protocol-specified* doses of metformin and pioglitazone or
- •On dual combination metformin and rosiglitazone, with an HbA1c of =7.0% and < or =10.5% at screening (stable doses for at least 8 weeks prior to screening), and has an HbA1c of =7.0% and < or =10.5% at Week -2, after at least 8 weeks on stable protocol-specified* doses of metformin and pioglitazone or
- •On a PPARgamma agent (pioglitazone or rosiglitazone) in dual combination with another oral AHA, with an HbA1c of =7.0% and < or =10.5% at screening (stable doses for at least 8 weeks prior to screening), and has an HbA1c of =7.0% and < or =10.5% at Week -2, after at least 8 weeks on stable protocol-specified* doses of metformin and pioglitazone or
- •On metformin, a PPARgamma agent (pioglitazone or rosiglitazone), and an SU or a DPP-4 inhibitor in triple combination therapy with an HbA1c of =6.5% and < or =9.5% at screening (stable doses for at least 8 weeks prior to screening), and has an HbA1c of =7.0% and < or =10.5% at Week -2, after at least 8 weeks on stable protocol-specified* doses of metformin and pioglitazone
- •*Protocol specified doses = metformin =2,000 mg per day (or =1,500 mg per day, if unable to tolerate a higher dose) and pioglitazone 30 mg or 45 mg per day.
- •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 criteria 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 criterion.
- •Site fasting fingerstick glucose of =110 mg/dL (6.1 mmol/L) and <270 mg/dL (15 mmol/L) on Day 1.
- •Note: at the investigator’s discretion, based upon review of recent SMBG values, subjects not meeting the Day 1 criteria may return to the investigational site within 7 days for a one-time repeat fingerstick glucose and continue in the study if the subject’s repeat fingerstick glucose meets the criterion.
- •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 clinic
排除标准
- •Diabetes-related or Metabolic
- •History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
- •Repeated FPG and/or fasting SMBG glucose measurements =270 mg/dL during the pre-treatment phase, despite reinforcement of diet and exercise counseling.
- •Have proliferative diabetic retinopathy for which treatment is planned during the course of the study
- •History of 1 or more severe hypoglycemic episode within 6 months before screening.
- •History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- •Ongoing, inadequately controlled thyroid disorder;
- •Required ongoing insulin therapy within 12 weeks prior to the screening visit
- •Ongoing eating disorder or significant weight loss or weight gain within 12 weeks, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, subject report
- •Renal/Cardiovascular
- •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
- •Myocardial infarction, unstable angina, revascularization procedure), 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 (refer to Attachment 3 of the protocol).
- •Findings on 12-lead ECG that would require urgent diagnostic evaluation or intervention
- •Uncontrolled hypertension at Week -2.
- •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.
- •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
- •Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 or serum creatinine =1.4 mg/dL (124 micromol/L) for men and =1.3 mg/dL (115 micromol/L) for women
- •Fasting serum triglycerides =600 mg/dL (6.74 mmol/L) at screening (or subsequent visit if not fasting at screening).
- •Note: a one-time repeat of the serum triglycerides is allowed, at the discretion of the investigator, if the screening value is not consistent with recent values
- •Alanine aminotransferase level >2.0 times the ULN or total bilirubin >1.5 times the ULN at screening (for elevations in bilirubin: if, in the opinion of the investigator and agreed upon by the sponsor’s medical officer, the elevation in bilirubin is consistent with Gilbert’s disease, the subject may participate)
- •Other conditions
- •History of malignancy within 5 years before screening (exceptions: squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy that in the opinion of the investigator, with concurrence with the sponsor’s medical monitor, is considered cured with minimal risk of recurrence)
- •Clinically important hematologic disorder (eg, symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia)
- •History of human immunodeficiency virus (HIV) antibody positive
- •Investigator’s assessment that the subject’s life expectancy is less than 1 year
- •Any condition that in the opinio
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