Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the change in Time in Range (TIR)
研究概览
简要总结
TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes. Participants using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participants will cross-over to the treatment that they did not receive in the first treatment period.
详细描述
TTP399-206 is a 20 week, Phase 2a trial designed to evaluate efficacy and safety of cadisegliatin in participants with T1D who are using hybrid closed loop (HCL) systems to manage their condition to gather preliminary data to understand how cadisegliatin performs in an HCL setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participants >= 18 years of age
- •Fasting C-peptide levels <0.6 ng/ml
- •Average TIR < 70% recorded on their personal CGM data collected over the past 7 days prior to Visit 1
- •Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration
- •Willing to wear a study provided CGM for study duration
- •Total bilirubin ≤2×ULN, ALT and AST ≤3×ULN
排除标准
- •Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.
- •Have been hospitalized for DKA within 3 months
- •Have uncontrolled hypothyroidism or hyperthyroidism
- •Have QTcF interval > 450 msec for males or > 470 msec for females
- •Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias
- •Have persistent, uncontrolled hypertension
- •Have clinically significant cardiovascular or cerebrovascular disease
- •Have proliferative retinopathy or maculopathy requiring acute treatment
- •Have a serious concomitant systemic disorder including but not limited to HIV or active Hep B or Hep C
- •Have been diagnosed and/or treated for malignancy within 3 years
- •Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,
研究组 & 干预措施
Cadisegliatin 800 mg QD, then Placebo
If a participant is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participant will cross-over to the placebo QD along with their insulin treatment
干预措施: Cadisegliatin 800 mg QD (Drug)
Cadisegliatin 800 mg QD, then Placebo
If a participant is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participant will cross-over to the placebo QD along with their insulin treatment
干预措施: Placebo (Drug)
Placebo, then Cadisegliatin 800 mg QD
If a participant is randomized to receive placebo QD along with their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participant will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment
干预措施: Cadisegliatin 800 mg QD (Drug)
Placebo, then Cadisegliatin 800 mg QD
If a participant is randomized to receive placebo QD along with their insulin treatment in the first double-blind treatment period of 6 weeks, there will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participant will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the change in Time in Range (TIR)
时间窗: last 2 weeks of the two 6-week treatment periods
Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo
次要结局
- To assess the change in Level 1, Level 2 , and Level 3 hypoglycemic incidence(12 weeks)
- CGM-based metric for glycemic control(last 2 weeks of each treatment period)
- Change in glucose control after standardized mixed meal tolerance test (MMTT)(12 weeks)
- Assess incidence of Serious Adverse Events (SAEs)(14 weeks)
- Assess incidence of Treatment Emergent Adverse Events (TEAEs)(14 weeks)
- Assess incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuation(14 weeks)
- Assess incidence of Adverse Events of Special Interest (AESIs)(14 weeks)
- Change from baseline in average daily total insulin dose(last week of the two 6-week treatment periods)