Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 140
- 主要终点
- Change in incidence of Level 2 or Level 3 hypoglycemia
研究概览
简要总结
This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.
详细描述
Study TTP399-302 is a 26-week, Phase 3 trial designed to measure the relative efficacy of adjunctive treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 hypoglycemia in participants with Type 1 Diabetes Mellitus compared to placebo (insulin alone) over 26 weeks of continuous therapy.
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
- Triple (Participant, Care Provider, 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
- •Individuals ≥18 years
- •Diagnosed T1DM with a minimum of 3 years since diagnosis
- •Has had at least 1 hypoglycemic event of Level 2 (glucose level <54 mg/dL or <3 mmol/L, [CGM or SMBG confirmed]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening
- •HbA1c value of <9.5% at Screening
- •Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study
- •Must have been on a CGM device for at least 3 months prior to Screening
排除标准
- •Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease
- •Has been hospitalized for DKA within 3 months prior to Screening
- •Has uncontrolled hypothyroidism or hyperthyroidism
- •History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight
- •Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ
- •Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) or weight loss medications within 30 days prior to the Screening
- •Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 30 days prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study.
- •Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening
- •Has uncontrolled hypertension prior to Screening
研究组 & 干预措施
Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD
The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.
干预措施: Cadisegliatin 800 mg QD (Drug)
Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID
The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.
干预措施: Cadisegliatin 800 mg BID (Drug)
Placebo: 26 Week Double Blind Treatment Period
The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in incidence of Level 2 or Level 3 hypoglycemia
时间窗: 26 weeks
Number of events of Level 2 or Level 3 hypoglycemia in participants on cadisegliatin vs placebo.
次要结局
- To assess the effects of treatment on body weight(26 weeks)
- To assess the incidence of treatment emergent adverse events(26 weeks)
- To assess the incidence of treatment emergent adverse events leading to discontinuation(26 weeks)
- To assess the change in HbA1c(26 weeks)
- To assess the effects of treatment on CGM-based metrics for glycemic control(26 weeks)
- To assess the effects of treatment on the incidence of diabetic ketoacidosis(26 weeks)
- To assess the effects of treatment on insulin dosing(18 weeks)
- To assess the change in HbA1c(26 weeks)
- To assess the effects of treatment on CGM-based metrics for glycemic control(26 weeks)
- To assess the effects of treatment on the incidence of diabetic ketoacidosis(26 weeks)
- To assess the effects of treatment on insulin dosing(18 weeks)
- To assess the effects of treatment on body weight(26 weeks)
- To assess the incidence of treatment emergent adverse events(26 weeks)
- To assess the incidence of treatment emergent adverse events leading to discontinuation(26 weeks)
- To assess the incidence of adverse events of special interest(26 weeks)