A Randomized Controlled Trial Comparing 21 Days of Continuous Subcutaneous Insulin Infusion (CSII) Using Hepatic Directed Vesicle (HDV) Insulin to Standard CSII in Type 1 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Glucose area under the curve
研究概览
简要总结
Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose Safety, Tolerability and Efficacy Study
详细描述
This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study.
The study will consist of three periods. Total duration will be approximately nine weeks, including a screening period of up to 14 days, a 7-day run-in period and two 21-day treatment periods.
Subjects will be screened and then they will undergo a week of baseline CGM. They will then be randomized to one of two treatment sequences: three weeks of treatment with HDV-lispro followed by three weeks of treatment with insulin lispro diluted with sterile water to match the insulin concentration in HDV-lispro, or the same treatments in the reverse order.
A test meal study (standardized liquid test meal) is to be conducted at the beginning of treatment (baseline study) and at the end of each three week treatment period. As noted above, frequent blood samples will be collected for glucose and insulin levels during the first (baseline study) test meal; during the two test meals performed after the two treatment periods the same sampling for glucose and insulin will be performed, with the addition of collecting samples for glucagon levels.
Subjects will also perform blinded continuous glucose monitoring throughout the entirety of the study (7 weeks).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1DM ≥12 months
- •C-peptide <0.6 ng/mL (a single re-test is allowable)
- •Treatment with rapid analog insulin by CSII for the previous 6 months
- •Familiarity with continuous glucose monitoring (CGM) technology; subjects nee d not be currently using CGM but should have used it in the past. Personal (unblinded) CGM will NOT be allowed during the study
- •Willingness to use insulin lispro as the analog insulin during the study period
- •Use of MiniMed Paradigm® pump for the previous 6 months. Pumps that employ low glucose suspend technology will NOT be allowed during the study
- •BMI ≥18.0 kg/m2 and ≤35.0 kg/m2
- •A1C≤9.0% (a single re-test is allowable)
排除标准
- •Known or suspected allergy to any component of any of the study drugs in this trial.
- •A patient who has unstable proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
- •Use of oral anti-diabetic or non-insulin anti-diabetic injection therapies (e.g. SGLT-2 inhibitors, pramlintide, GLP-1 agonists, etc.)
- •Current smokers; if a former smoker, no tobacco products (inhaled, oral or buccal) for the previous 3 months
- •As judged by the investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG), hepatic, neurological, renal, genitourinary, or hematological systems, or uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position).
- •History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the patient.
研究组 & 干预措施
HDV insulin lispro 100 UNIT/mL
Hepatic Directed Vesicle (HDV) is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.
干预措施: HDV insulin lispro 100 UNIT/mL (Drug)
Insulin Lispro 100 UNIT/mL
Sterile Water for Injection (SWFI) is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro
干预措施: Insulin Lispro 100 Units/mL (Drug)
结局指标
主要结局
Glucose area under the curve
时间窗: 21 days
To evaluate glucose response (incremental AUC) to standardized test meal challenge following 21 days of CSII treatment with HDV insulin lispro versus insulin lispro diluted with sterile water
次要结局
- total units Insulin(21 days)