A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Change from baseline of HbA1c at week 12
研究概览
简要总结
This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM.
Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 to 75 years of age, inclusive.
- •Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).
- •Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, at screening and visit 3.
排除标准
- •Have type 1 diabetes mellitus.
- •Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
- •Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range at screening.
- •Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
- •Have serum calcitonin ≥20 ng/L at screening.
- •Fasted triglycerides > 5.7 mmol/L at screening.
研究组 & 干预措施
HEC88473 dose1
T2DM subjects, receiving a weekly dose of HEC88473 dose1
干预措施: HEC88473, Placebo, Dulaglutide (Drug)
HEC88473 dose2
T2DM subjects, receiving a weekly dose of HEC88473 dose2
干预措施: HEC88473, Placebo, Dulaglutide (Drug)
HEC88473 dose3
T2DM subjects, receiving a weekly dose of HEC88473 dose3
干预措施: HEC88473, Placebo, Dulaglutide (Drug)
Placebo
T2DM subjects, receiving a weekly dose of placebo
干预措施: HEC88473, Placebo, Dulaglutide (Drug)
Dulaglutide
T2DM subjects, receiving a weekly dose of dulaglutide
干预措施: HEC88473, Placebo, Dulaglutide (Drug)
结局指标
主要结局
Change from baseline of HbA1c at week 12
时间窗: Baseline to week 12
HbA1c
次要结局
- Change from baseline of fasting blood-glucose at week 12(Baseline to week 12)
- Change from baseline of weight at week 12(Baseline to week 12)
- Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline to week 15)