A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Immunogenicity Tests
研究概览
简要总结
A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have diagnosed with type 2 diabetes for at least 3 months before enrollment.
- •Have diet and exercise intervention only (for part A and part B) or been treated with stable dose of metformin as monotherapy for at least 3 months (for part B only)
- •Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory.
- •Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m^2).
排除标准
- •Type 1 diabetes (T1D).
- •Evidences of fasting C-peptide levels<0.81 ng/mL.
- •History of trauma, infection or surgery within a month;
- •History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months.
- •History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors.
- •Evidence of abnormal thyroid function within 6 months before screening.
- •Positive test results in HBsAg, HCVAB, HIVAB or TPAB.
- •History of serious mental illness.
- •History of drug or alcohol abuse.
- •History of a transplanted organ, acquired or congenital immune system diseases.
- •Allergy to active ingredients or excipients of the test drug.
- •Evidence of abnormal result of laboratory examination according to the judgment of researchers.
- •Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study.
- •Previously completed or withdrawn from this study after providing informed consent.
研究组 & 干预措施
Supaglutide (Part A)
Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients.
干预措施: Supaglutide (Drug)
Placebo(Part A)
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
干预措施: Placebo (Drug)
Supaglutide (Part B)
Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients.
干预措施: Supaglutide (Drug)
Placebo (Part B)
Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
干预措施: Placebo (Drug)
结局指标
主要结局
Immunogenicity Tests
时间窗: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Immunogenicity Tests
Vital Sign
时间窗: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Vital Sign
Laboratory Tests
时间窗: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of Laboratory Tests
12-lead ECGs
时间窗: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Assessments of 12-lead ECGs
HbA1c
时间窗: Baseline, 7 weeks, 17weeks
Change from Baseline in Hemoglobin A1c (HbA1c)
Adverse Events
时间窗: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
Number of Adverse Events
次要结局
- Fasting Blood Insulin(Baseline, 7 weeks, 17weeks)
- Fasting Blood C-peptide(Baseline, 7 weeks, 17weeks)
- Pharmacokinetics (PK): t½ of Supaglutide(Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A))
- Glycosylated Albumin(Baseline, 7 weeks, 17weeks)
- Fasting Blood Glucose(Baseline, 7 weeks, 17weeks)
- Blood Lipid(Baseline, 7 weeks, 17weeks)
- PK: Tmax of Supaglutide(Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A))
- HbA1c <7%(Baseline, 7 weeks, 17weeks)
- Body Weight(Baseline, 7 weeks, 17weeks)
- Pharmacokinetics (PK): Area Under the Curve(Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A))