A Phase 2b Randomized, Double-blind Trial Comparing HDV-Insulin Lispro Versus Insulin Lispro Alone in Adults With Type 1 Diabetes Receiving Insulin Degludec
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 51
- 主要终点
- hypoglycemia percentage of time
研究概览
简要总结
The goal of this study is to see if directing insulin to the liver will improve the low blood sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants will use continuous glucose monitoring to measure the sugar levels in their blood, and work with the doctor to find the best doses. One group of patients will get the liver targeting insulin, and the other group will use insulin they normally use for treating Type 1 diabetes. The participant will be part of the study for up to 32 weeks.
详细描述
Individuals age 18 up to 80 years with Type 1 diabetes using multiple daily injections of bolus insulin plus basal insulin will be enrolled into a double-blind randomized controlled trial to assess the efficacy, safety, and tolerability of Hepatocyte-Directed Vesicles-insulin lispro (HDV-L) versus lispro alone (LIS) used in combination with insulin degludec. The study includes (1), a screening period up to 3 weeks, (2), a Run-in Period of 2 weeks to assess eligibility and to transition to use of insulin lispro and insulin degludec and unmasked continuous glucose monitoring (CGM), )3), a 12-week dose optimization period to optimize bolus and basal insulin doses,, (4), a 13-week maintenance period, and (5), a 2 -week transition follow-up period.
The primary objective of the study is to determine if the addition of HDV to insulin lispro results in an improvement in glycemic control as defined by decreasing evidence of nocturnal hypoglycemia while maintaining or improving glycated hemoglobin (HbA1c). Other outcomes related to glycemic control will also be evaluated.
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)
盲法说明
Enrolled subjects randomized to either the treatment arm or the control arm. The patient, the study site personnel, the CRO, and the sponsor are blinded to which group the patient is randomized to. Only the site pharmacist, and one study monitor from the CRO are unblinded. The Medical Monitor is blinded unless there is a medical reason for unblinding.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis Type 1 diabetes with C-peptide <=0.6 ng/mL and using insulin for at least 6 months
- •willing to use study provided insulin as the only bolus insulin and insulin degludec as the basal insulin
- •willing to use CGM device throughout the study
- •screening A1C >= 6.5% and <= 10.0% daily insulin dose <= 1.25 U/kg/day
排除标准
- •known or specific allergy to any component of the study drug, the active comparator
- •pregnant or breast-feeding, or plans to become pregnant at any time during duration of study
- •current use of hydroxyurea
- •use of noninsulin glucose-lowering medications other than metformin, weight loss medications or dietary supplements for weight loss within 30 days, or anticipated use during the course of the study
- •received any investigational drug within prior 30 days
- •Clinically significant abnormalities on screening laboratory testing including liver enzymes
- •Presence of a medical condition or use of a medication that could compromise the results of the study or the safety of the subject (eg. alcohol or drug abuse, uncontrolled hypertension, history of transient ischemic attack or stroke within the last 12 months)
- •employed by or having immediate family members employed by the sponsor or directly involved in conducting the clinical trial.
研究组 & 干预措施
Lispro (LIS)
Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin
干预措施: Lispro (Drug)
HDV Lispro (HDV-L)
Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin
干预措施: HDV-Lispro (Drug)
结局指标
主要结局
hypoglycemia percentage of time
时间窗: during the first 6 weeks of maintenance period
CGM-measured nocturnal percent time
hypoglycemia events
时间窗: during the first 6 weeks of the maintenance period
CGM-measured rates of nocturnal level 2 hypoglycemia events
次要结局
- blood chemistry values(baseline through study completion, an average of 7 months)