A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of CT-868 Administered for 16 Weeks to Overweight and Obese Adult Participants With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 22
- 主要终点
- Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
研究概览
简要总结
This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older at the time of signing informed consent
- •Have a documented clinical diagnosis of T1DM greater than or equal to 1 year before the Screening Visit
- •Body mass index greater than or equal to27.0 kg/m2
- •Hemoglobin A1c (HbA1c) level between 7.0% and 10.0%, inclusive, at the Screening Visit
排除标准
- •Diagnosis of Type 2 diabetes mellitus (T2DM) or any other types of diabetes, except T1DM
- •Experienced diabetic ketoacidosis (DKA) within 3 months prior to the Screening Visit
- •Experienced severe hypoglycemia (Level 3 as defined in the ADA Standards of Medical Care in Diabetes (ADA 2022) within 3 months prior to the Screening Visit
研究组 & 干预措施
CT-868 Low Dose
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks.
干预措施: CT-868 (Drug)
CT-868 Low Dose
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 1.8 mg, and it will be administered once daily for a total duration of 16 weeks.
干预措施: CT-868 Pen Injector (Device)
CT-868 Medium Dose
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks.
干预措施: CT-868 (Drug)
CT-868 Medium Dose
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 4.1 mg, and it will be administered once daily for a total duration of 16 weeks.
干预措施: CT-868 Pen Injector (Device)
CT-868 High Dose
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks.
干预措施: CT-868 (Drug)
CT-868 High Dose
Participants in this arm will receive the drug CT-868 in a subcutaneous injection form. The dosage is set at up to 6.6 mg, and it will be administered once daily for a total duration of 16 weeks.
干预措施: CT-868 Pen Injector (Device)
CT-868 Placebo
Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks.
干预措施: CT-868 Pen Injector (Device)
CT-868 Placebo
Participants in this arm will receive a placebo designed to match the appearance and formulation of the drug CT-868. The intervention consists of a subcutaneous injection of this placebo. The placebo will be administered once daily for a duration of 16 weeks.
干预措施: CT-868 Pen Injector, Placebo (Drug)
结局指标
主要结局
Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline
时间窗: at Day 1 to Week 16
次要结局
- To assess the percentage of participants achieving HbA1c of <7.0%.(at Week 16)
- To assess the percentage of participants achieving HbA1c of ≤6.5%.(at Week 16)
- Compare the effect of CT-868 versus placebo on change in HbA1c (%) from baseline(at Day 1 to Weeks 4, 8, and 12)
- Change in body weight (in kilograms) from baseline when comparing CT-868 to placebo.(at Day 1 to Week 16)
- To assess the percentage of participants achieving HbA1c of <5.7%.(at Week 16)
- Change in insulin doses from baseline when comparing CT-868 to placebo.(at Day 1 to Weeks 8 and 16)