ACTRN12610000194066已完成3 期
A Randomised Double-Blind Placebo-Controlled Multicenter Study with Extension to Evaluate the Efficacy Safety and Tolerability of Canagliflozin in the Treatment of Subjects with Type 2 DiabetesMellitus Who Have Moderate Renal
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Man or woman with Type 2 diabetes Mellitus (T2DM), age =25 years, and either not on an anti hyperglycemic agent (AHA) or on any AHA in monotherapy or combination therapy (including oral or non-oral agents).
- •2) HbA1c =7.0% to =10.5% at screening and Week -2 visits.
- •3) On a stable AHA regimen consistent with local prescribing information (ie, local
- •label[s]) for at least 8 weeks (and 12 weeks for peroxisome proliferator-activated receptors (PPAR) agents [eg, rosiglitazone or pioglitazone]) before Week -2.
- •4) Have moderate renal impairment, as defined by eGFR values (estimated by the
- •4-variable Modification of Diet in Renal Disease (MDRD) equation) =30 and <50 mL/min/1.73 m2 at both the screening and
- •the Week -2 visit, with generally stable renal function, as demonstrated by =25%
- •decline in eGFR at Week-2 relative to the screening visit value
- •5) Fasting plasms glucose (FPG) =270 mg/dL (15 mmol/L) at
- •6) Site fasting fingerstick glucose of =110 mg/dL (6.1 mmol/L) and =270 mg/dL
- •(15 mmol/L) on Day 1
- •Women must be on a highly effictive method of birth control
- •7) Women of childbearing potential must have a negative urine beta-human chorionic
- •gonadotropin (beta-hCG) pregnancy test at screening and baseline (predose, Day 1).
- •8) Willing and able to adhere to the prohibitions and restrictions specified in this
- •9) 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.
- •10) To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research
- •indicating willingness to participate in the pharmacogenomic component of the study
- •(where local regulations permit). Refusal to give consent for this component does not
- •exclude a subject from participation in the clinical study.
- •11) Adequate compliance with the run-in period study procedures, including performance of the self monitored blood glucose (SMBG) measurements (completed at least 3 or more SMBG measurements per week) with appropriate diary entries, and =80% compliance (by pill count) with single-blind placebo capsules.
排除标准
- •1) History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or
- •diabetes secondary to pancreatitis or pancreatectomy
- •2) 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 pretreatment phase, despite
- •reinforcement of diet and exercise counseling
- •3) Have proliferative diabetic retinopathy for which treatment is planned during the
- •course of the study
- •4) History of 1 or more severe hypoglycemic episode within 6 months before screening.
- •5) History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- •6) Ongoing, inadequately controlled thyroid disorder (eg, subject has a known thyroid
- •stimulating hormone [TSH] value that is either <0.2 or >10 mIU/L)
- •7) 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
- •8) Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant
- •9) Presence of nephrotic syndrome (eg, severe proteinuria with hypoalbuminemia and/or edema), or inflammatory renal disease (eg, acute interstitial nephritis, acute or rapidly-progressive glomerulonephritis)
- •10) Subject is likely to require dialysis or transplantation during participation in the study
- •11) 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
- •12) Association (NYHA) Class III-IV cardiac disease (refer to Attachment 3, New York
- •Heart Association Classification of Cardiac Disease, for a description of the classes)
- •13) Findings on 12-lead ECG that would require urgent diagnostic evaluation or
- •intervention (eg, new clinically important arrhythmia or conduction disturbance)
- •14) 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
- •15) History of hepatitis B surface antigen or hepatitis C antibody positive (unless associated with documented persistently stable/normal range aspartate
- •aminotransferase [AST] and Alanine Transaminase (ALT) levels, or other clinically active liver disease
- •16) History of prior bariatric surgical procedure within 3 years before the screening visit
- •17) Fasting serum triglycerides =600 mg/dL (6.74 mmol/L) at screening (or subsequent
- •visit if not fasting at screening)
- •18) Alanine aminotransferase level >2.0 times the upper limit of normal (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)
- •19) Hemoglobin concentration <10 g/L at screening
- •20) 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)
- •21) Clinically important hematologic disorder (eg, symptomatic anemia, proliferative bone
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