A Randomized, Placebo-controlled, Three-Way Crossover Study to Evaluate the Effect of SCH 497079 on Metabolic Parameters and to Determine the Influence of Race/Ethnic Origin on Therapeutic Response
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)
研究概览
简要总结
The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.
详细描述
This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or metformin.
Part 2 (to be conducted in India): this part of the study will be conducted after completion of Part 1 and an analysis indicates a clinically significant decrease in blood glucose in participants with type 2 diabetes mellitus (T2DM) compared to placebo. The same procedures conducted in Part 1 will be conducted in Part 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •>=18 years of age to 65 years of age, of either sex, and having a body mass index (BMI) between 27 and 35, inclusive (USA participants)
- •Clinical laboratory tests (complete blood count, blood chemistry, and urinalysis) within normal limits (excluding glucose and other changes usually associated with diabetes eg, dyslipidemia)
- •Type 2 diabetes mellitus
排除标准
- •Female participants who are premenopausal or are not surgically sterilized. Participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breast-feeding.
- •Participants who have received insulin therapy within 6 months, prior to Day 1/Period 1 or who require thiazide diuretics, beta-blockers and cyclic hormone therapy.
研究组 & 干预措施
Treatment sequence 1: SCH 497079 → Placebo → Metformin
Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks.
干预措施: SCH 497079 (Drug)
Treatment sequence 1: SCH 497079 → Placebo → Metformin
Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks.
干预措施: Placebo (Drug)
Treatment sequence 1: SCH 497079 → Placebo → Metformin
Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks.
干预措施: Metformin (Drug)
Treatment sequence 2: Placebo → Metformin → SCH 497079
Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
干预措施: SCH 497079 (Drug)
Treatment sequence 2: Placebo → Metformin → SCH 497079
Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
干预措施: Placebo (Drug)
Treatment sequence 2: Placebo → Metformin → SCH 497079
Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
干预措施: Metformin (Drug)
Treatment sequence 3: Metformin → SCH 497079 → Placebo
Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks.
干预措施: SCH 497079 (Drug)
Treatment sequence 3: Metformin → SCH 497079 → Placebo
Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks.
干预措施: Placebo (Drug)
Treatment sequence 3: Metformin → SCH 497079 → Placebo
Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks.
干预措施: Metformin (Drug)
Treatment sequence 4: SCH 497079 → Metformin → Placebo
Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks.
干预措施: SCH 497079 (Drug)
Treatment sequence 4: SCH 497079 → Metformin → Placebo
Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks.
干预措施: Placebo (Drug)
Treatment sequence 4: SCH 497079 → Metformin → Placebo
Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks.
干预措施: Metformin (Drug)
Treatment sequence 5: Placebo → SCH 49709 → Metformin
Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks.
干预措施: SCH 497079 (Drug)
Treatment sequence 5: Placebo → SCH 49709 → Metformin
Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks.
干预措施: Placebo (Drug)
Treatment sequence 5: Placebo → SCH 49709 → Metformin
Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks.
干预措施: Metformin (Drug)
Treatment sequence 6: Metformin → Placebo → SCH 497079
Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
干预措施: SCH 497079 (Drug)
Treatment sequence 6: Metformin → Placebo → SCH 497079
Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
干预措施: Placebo (Drug)
Treatment sequence 6: Metformin → Placebo → SCH 497079
Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
干预措施: Metformin (Drug)
结局指标
主要结局
Pharmacodynamic: Change From Baseline in Mean 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)
时间窗: Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28
Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.
Pharmacodynamic: Change From Baseline in 24-hour Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)
时间窗: Pre-dose (-30 mnutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28
Change from baseline in 24-hour plasma glucose on the last day of treatment. On the day of the glucose collections (and the day prior to), standardized meals (breakfast, lunch, dinner, and snack) were provided and consumed over 15 minutes. AUC/duration is presented as mg/dL and was calculated by dividing AUC (mg/dL\*hr) by the duration in hours. Model-based least squares mean: ANOVA extracting the effects due to treatment, sequence, period and participant.
次要结局
- Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 2 - India)(Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28)
- Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 1 - United States)(Baseline and Week 4)
- Pharmacodynamic: Change From Baseline in Plasma Glucose During the 12-hour Post Absorptive State (AUC/Duration) at Week 4 (Part 2 - India)(Baseline and Week 4)
- Number of Participants Who Experienced at Least One Adverse Event (Part 1 - United States)(Up to 14 days after last dose of study drug (up to 98 days))
- Number of Participants Who Experienced at Least One Adverse Event (Part 2 - India)(Up to 14 days after last dose of study drug (up to 98 days))
- Pharmacodynamic: Change From Baseline in 12-hour Postprandial Plasma Glucose (AUC/Duration) at Week 4 (Part 1 - United States)(Pre-dose (-30 minutes), pre-standard breakfast (0 hour), 0.5, .75, 1, 2, 3, 4, 4.5, 4.75, 5, 6, 7, 8, 9, 9.5, 9.75, 10, 11, 12, 13, 14, 15, 16, and 24 hours after the beginning of the standardized breakfast on Day -1 and Day 28)
- Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 1 - United States)(Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug)
- Pharmacokinetic: Mean Plasma Glucose (Over 24 Hours) at Week 4 (Part 2 - India)(Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug)
- Pharmacokinetic: Mean Maximum Observed Plasma Concentration (Cmax) (Part 1 - United States)(Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug)
- Pharmacokinetic: Mean Plasma Cmax (Part 2 - India)(Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug)
- Pharmacokinetic: Mean Time to Maximum Observed Plasma Concentration (Tmax) (Part 1 - United States)(Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug)
- Pharmacokinetic: Mean Plasma Tmax (Part 2 - India)(Pre-dose (0 hour), 0.5, 1, 2, 6, 12, and 24 hours after administration of study drug)