Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 34
- 主要终点
- Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
研究概览
简要总结
SPIL1033 resembles a gut hormone, which increases the insulin secretion, thus helps in reducing blood glucose levels. The purpose of study is to establish safety and efficacy of SPIL1033
详细描述
SPIL1033 is subcutaneous injection is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus.
In this study, efficacy and safety of SPIL1033 will be evaluated. Subjects will receive SPIL1033 or placebo, 5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects 20 years of age and older.
- •Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
- •Weight stable: their weight should not have varied more than 10% of screening visit weight, within 6 months prior to screening visit.
- •Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s); with a negative urine pregnancy test.
- •Willing to participate and give written informed consent.
排除标准
- •Previous exposure to exenatide (anti-exenatide antibodies at screening) or a glucagon-like peptide (GLP-1) analogue.
- •Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, rimonabant, or similar over-the-counter medications) within 3 months of screening.
- •Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of trial entry.
- •Severe renal impairment (creatinine clearance <30 ml/min) or end stage renal disease.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
SPIL1033
干预措施: SPIL1033 (Drug)
结局指标
主要结局
Count and Percentage of Subjects Positive for Anti-exenatide Antibodies
时间窗: 24 weeks
Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs)
时间窗: 24 weeks
Change From Baseline to End of Study in Hemoglobin A1c (HbA1c)
时间窗: 24 weeks
Change From Baseline to End of Study in Fasting Plasma Glucose (FPG)
时间窗: 24 weeks
次要结局
- Change From Baseline in Triglycerides(24 weeks)
- Change From Baseline in 2hour Postprandial Glucose (2-h PPG)(24 weeks)
- Change From Baseline in High Density Lipoproteins(24 weeks)
- Change From Baseline in Very Low Density Lipoproteins(24 weeks)
- Change From Baseline in Low Density Lipoproteins(24 weeks)
- Change in Body Weight(24 weeks)
- Subjects Achieving Hemoglobin A1c (HbA1c) < 7%(24 weeks)
- Change From Baseline in Total Cholesterol(24 weeks)