Canagliflozin-Mealtime Insulin Rescue
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of patients who discontinue all pre-meal medications for at least one meal per day
研究概览
简要总结
24-week, randomized, double blind, placebo-controlled trial to evaluate safety and efficacy of canagliflozin as compared with placebo in reducing the need for mealtime insulin in subjects with type 2 diabetes currently using a basal-bolus insulin regimen.
详细描述
The Canagliflozin Mealtime Insulin Rescue study will enroll up to 40 subjects at the Atlanta VA Medical Center. Subjects will be screened and enter a 2-week run-in period during which they will switch to or continue on a diabetes treatment regimen of basal insulin before supper and aspart insulin before meals. Run-in will be useful in evaluating compliance to treatment and self-monitoring. After run-in, subjects will collect one week of baseline glycemic data with regular pre-meal and fasting glycemic levels using both finger stick testing and continuous glucose monitoring.
Subjects will be randomized at Visit 3 to 100 mg of canagliflozin or placebo. If well tolerated, this dose will be increased to 300 mg of canagliflozin or placebo at Visit 4.
Diabetes management will be assured through regular contact with the study team (weekly calls and clinic visits at Weeks 4, 8, 16 and 24). Management will be facilitated by diabetes management software. Self-monitoring and continuous glucose monitoring will be repeated at the end of study participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •use of basal-bolus insulin
- •onset of diabetes after age 30
- •BMI less than 35
- •eGFR at least 60 ml/mn
- •Hb A1c 7.0-10.0%
- •willingness to perform home glucose monitoring
- •willingness to transmit glucose and medication information weekly
排除标准
- •Type 1 diabetes
- •Known peripheral artery disease
- •Liver enzymes equal or more than 1.5 times the upper limit of normal
- •Chronic heart failure NYHA class III or IV
- •Current haemodialysis or peritoneal dialysis
- •End stage liver disease, defined as acute or chronic liver disease and recent history of one of the following: ascites, encephalopathy, variceal bleeding, bilirubin equal or greater than 2.0 mg/dL, albumin equal or less than 3.5 g/ dL, prothrombin time greater or equal to 4 seconds, INR greater than or equal to 1.7 or prior liver transplant
- •Known or suspected hypersensitivity to trial products or related products
- •Female of child-bearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods as required by law or local practice.
- •Expected simultaneous participation in any other clinical trial of an investigational medicinal product.
- •Receipt of any investigational medicinal product within 30 days before randomization
- •Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
- •Any condition that in the investigator's opinion would make the subject unable to adhere to the trial visit schedule and procedures
- •Known history of non-compliance to treatment.
研究组 & 干预措施
canagliflozin
Subjects randomized to this arm will start with 100 mg tablet and increase to 300 mg tablet at Visit 4 if well tolerated.
干预措施: canagliflozin (Drug)
placebo
Subjects randomized to this arm will start with 100 mg tablet and increase to 300 mg tablet at Visit 4 if well tolerated.
干预措施: placebo (Drug)
结局指标
主要结局
Number of patients who discontinue all pre-meal medications for at least one meal per day
时间窗: 24 weeks
Number of patients with a continuing need for insulin 4 times per day
时间窗: 24 weeks
no change from the original basal -bolus regimen
Frequency and severity of hypoglycemia
时间窗: 24 weeks
Hypoglycemic episodes will be evaluated using a hypoglycemia questionnaire
Number of patients who replace mealtime insulin with an oral agent for at least one meal per day
时间窗: 24 weeks
anti-hyperglycemic pill instead of insulin for at least one meal per day
Self monitoring and continuous monitoring blood glucose levels
时间窗: 24 weeks
glycemic control and glycemic variability
次要结局
未报告次要终点