Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Number of Subjects With Treatment-emergent Adverse Events
研究概览
简要总结
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy
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
- Single (Participant)
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
- •Diagnosis of T2DM for at least 12 weeks prior to the Screening Visit
- •Currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the Screening Visit and until Day -3
- •Have a glycosylated hemoglobin (HbA1c) value of between 6.5% and 10.0% at the Screening Visit
- •Have a fasting plasma glucose (FPG) value of no more than 280 mg/dL at the Screening Visit and on Day -3
- •Body Mass Index (BMI) of 25 to 40 kg/m2 (inclusive)
排除标准
- •Known medical history or presence of Type 1 diabetes mellitus, Maturity Onset Diabetes of the Young or secondary forms of diabetes
- •Known medical history or presence of diabetic complications
- •Have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the Screening Visit or from the Screening Visit to Day -3
- •Have uncontrolled hypertension (systolic blood pressure of at least 160 mmHg or diastolic blood pressure of at least 95 mmHg) at the Screening Visit
- •Have impaired renal function (estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2)
研究组 & 干预措施
JTT-662 5 mg
JTT-662 5 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
干预措施: JTT-662 (Drug)
JTT-662 10 mg
JTT-662 10 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
干预措施: JTT-662 (Drug)
JTT-662 20 mg
JTT-662 20 mg orally once daily from Day 1 to Day 28, after a single dose of placebo on Day -1
干预措施: JTT-662 (Drug)
Placebo
Placebo orally once daily from Day -1 to Day 28
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects With Treatment-emergent Adverse Events
时间窗: 6 Weeks (from Day -1 to the follow-up visit on Day 42)
Treatment-emergent adverse event is defined as any adverse event (untoward medical experience occurring to a subject whether or not it is related to the study drug) with an onset date/time at/after the placebo dosing on Day -1.
Number of Stools and Type of Stools Based on Bristol Stool Chart
时间窗: 7 Weeks (from Day -6 to the follow-up visit on Day 42)
Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool Chart. The Bristol Stool Chart was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation while a score of 6 or 7 indicates diarrhea.
Trough Concentrations of JTT-662 in Plasma on Days 1, 7, 10, 14, 15, 21 and 28
时间窗: 28 Days
Trough plasma concentration is the measured concentration at the end of a dosing interval at steady state (taken directly before next administration). Blood samples were collected at specific timepoints to measure trough plasma concentrations of JTT-662 in the subjects randomized to JTT-662 treatment groups.
Change From Baseline in AUEC0-4 for Plasma Postprandial Glucose (PPG) Compared to Placebo on Days 1, 14 and 28
时间窗: Days 1, 14 and 28
Change from baseline in the AUEC0-4 (area under the observed effect-time curve from the start of breakfast until the 4 hour time point) for PPG were calculated using the corresponding Day -1 value as baseline and compared to the placebo values. Negative values represent greater reduction in PPG from baseline values compared to placebo.
次要结局
未报告次要终点