A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.
详细描述
Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of S-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the past 3 months (with no other medication for glycemic control) and who are clinically stable as determined by medical history
- •Body mass index (BMI) ≥25.0 and <45.0 (kg/m2) using http://www.bmicalculator.org/ as the BMI calculator
- •No clinically significant abnormal laboratory tests as determined by the investigator except Hemoglobin A1c level ≥7.5% and ≤11.0% and C peptide level >1.0 ng/mL
排除标准
- •Type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months
- •Use of any medication for glycemic control other than metformin during the past 3 months or thiazolidinediones within the past year
- •Congestive heart failure as defined by New York Heart Association class III or IV
- •Fasting glucose >270 mg/dL
- •Creatinine clearance is <60 mL/minute
- •History of myocardial infarction within the past 3 months, history of clinically significant cardiac arrhythmia, clinically significant hypotension or hypertension, or clinically significant abnormal electrocardiogram as determined by the investigator
研究组 & 干预措施
S-707106 Dose A
One S-707106 A tablet + 3 Placebo A tablets
干预措施: S-707106 Dose A (Drug)
S-707106 Dose A
One S-707106 A tablet + 3 Placebo A tablets
干预措施: Placebo A tablet (Drug)
S-707106 Dose A
One S-707106 A tablet + 3 Placebo A tablets
干预措施: Metformin (Drug)
S-707106 Dose B
One S-707106 B tablet + 3 Placebo A tablets
干预措施: S-707106 Dose B (Drug)
S-707106 Dose B
One S-707106 B tablet + 3 Placebo A tablets
干预措施: Placebo A tablet (Drug)
S-707106 Dose B
One S-707106 B tablet + 3 Placebo A tablets
干预措施: Metformin (Drug)
S-707106 Dose C
S-707106 Dose C = Four S-707106 B tablets
干预措施: S-707106 Dose C (Drug)
S-707106 Dose C
S-707106 Dose C = Four S-707106 B tablets
干预措施: Metformin (Drug)
Metformin
The standard of care dose of metformin for the individual patient + 3 Placebo A tablets
干预措施: Placebo A tablet (Drug)
Metformin
The standard of care dose of metformin for the individual patient + 3 Placebo A tablets
干预措施: Metformin (Drug)
结局指标
主要结局
Change from Baseline to Week 12 in Hemoglobin A1c (HbA1c)
时间窗: Baseline and at 12 weeks
Hemoglobin A1c
次要结局
- Sparse pharmacokinetic assessments(5 days)
- Change from Baseline at Week 12 in: Fasting plasma glucose, 1,5-Anhydroglucitol, Fructosamine, Glycoalbumin, C-peptide, Beta-cell function and insulin resistance indices using Homeostatic Model Assessment, and Postprandial glucose test(Baseline and at 12 weeks)
- Safety assessments(5-6 months)
- Serial pharmacokinetic (PK) assessments(5 days)
- Percent of subjects with Hemoglobin A1c < 7.0% at Week 12(12 weeks)