A Randomized, Open Label, Two-part, Three-period, Cross Over Study to Investigate the Effects of Carbohydrate in Diet and to Evaluate Supplements on the Gastrointestinal Tolerability of LIK066 in Overweight or Obese Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Number of Episodes of Diarrhea (Part A and Part B)
研究概览
简要总结
The purpose of this study was to determine if LIK066 taken with a meal containing low carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to assess the potential effects of supplements such as psyllium or calcium carbonate on alleviating diarrhea associated with LIK066.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •obese and overweight, BMI 25-50, HbA1C <10%
排除标准
- •Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
干预措施: LIK066 (Drug)
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
干预措施: Carbohydrate 50% (Dietary Supplement)
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
干预措施: Carbohydrate 25% (Dietary Supplement)
Part A: LIK066 + P1: 50% CHO / P2: 25% CHO / P3: 0% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 50% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 25% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 0% carbohydrate
干预措施: Carbohydrate 0% (Dietary Supplement)
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
干预措施: LIK066 (Drug)
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
干预措施: Carbohydrate 50% (Dietary Supplement)
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
干预措施: Carbohydrate 25% (Dietary Supplement)
Part A: LIK066 + P1: 25% CHO / P2: 0% CHO / P3: 50% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 25% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 0% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 50% carbohydrate
干预措施: Carbohydrate 0% (Dietary Supplement)
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
干预措施: LIK066 (Drug)
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
干预措施: Carbohydrate 50% (Dietary Supplement)
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
干预措施: Carbohydrate 25% (Dietary Supplement)
Part A: LIK066 + P1: 0% CHO / P2: 50% CHO / P3: 25% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 0% carbohydrate (CHO) Period 2 (Day 9-11): Daily dose of 50 mg LIK066 + 50% carbohydrate Period 3 (Day 17-19): Daily dose of 50 mg LIK066 + 25% carbohydrate
干预措施: Carbohydrate 0% (Dietary Supplement)
Part A: LIK066 + P1: 8% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
干预措施: LIK066 (Drug)
Part A: LIK066 + P1: 8% CHO
Period 1 (Day 1-3): Daily dose of 50 mg LIK066 + 8% carbohydrate (CHO) PROTOCOL DEVIATION: subjects received 8% CHO in error and were discontinued after Period 1.
干预措施: Carbohydrate 8% (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
干预措施: LIK066 (Drug)
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
干预措施: Carbohydrate 50% (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
干预措施: Psyllium (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: NS / P2: PS / P3: CC
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC)
干预措施: Calcium carbonate (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
干预措施: LIK066 (Drug)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
干预措施: Carbohydrate 50% (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
干预措施: Psyllium (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: PS / P2: CC / P3: NS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS)
干预措施: Calcium carbonate (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
干预措施: LIK066 (Drug)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
干预措施: Carbohydrate 50% (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
干预措施: Psyllium (Dietary Supplement)
Part B: LIK066 + 50% CHO + P1: CC / P2: NS / P3: PS
Period 1 (Day 1-3): Daily dose of 50 mg LIK066+50% carbohydrate +1g calcium carbonate (CC) Period 2 (Day 9-11): Daily dose of 50 mg LIK066+50% carbohydrate + no supplement (NS) Period 3 (Day 17-19): Daily dose of 50 mg LIK066+50% carbohydrate + 6 g psyllium (PS)
干预措施: Calcium carbonate (Dietary Supplement)
结局指标
主要结局
Number of Episodes of Diarrhea (Part A and Part B)
时间窗: 24 hours on Day 3 of each treatment period
Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.
次要结局
- Average Stool pH (Part A and Part B)(24 hours on Day 3 of each treatment period)
- Average Consistency With Bristol Stool Chart (Part A and Part B)(24 hours on Day 3 of each treatment period)
- Three-day Total Number of Episodes of Diarrhea (Part A and Part B)(Day 1 to 3 of each treatment period)
- Average Stool Weight (Part A and Part B)(24 hours on Day 3 of each treatment period)