A Study Investigating the Pharmacokinetic and Pharmacodynamic Properties and Safety and Tolerability of Three Formulations of NNC0471-0119 When Administered as One Bolus in a Continuous Subcutaneous Insulin Infusion Regimen in Participants With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
研究概览
简要总结
This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.
The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.
The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).
Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.
Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.
The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.
During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.
Women: Women cannot take part if they are of childbearing potential.
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 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- •Aged 18-64 years (both inclusive) at the time of signing informed consent.
- •Diagnosed with T1DM for more than1 year prior to the day of screening.
- •Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
- •Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.
排除标准
- •Known or suspected hypersensitivity to study interventions or related products.
- •Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.
研究组 & 干预措施
Arm 1
A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)
干预措施: NNC0471-0119 A (Drug)
Arm 2
A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)
干预措施: NNC0471-0119 B (Drug)
Arm 3
A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)
干预措施: NNC0471-0119 D (Drug)
Arm 4
A single dose of NNC0471-0119 A, NNC0471-0119 B, NNC0471-0119 D and Faster Aspart at each of 4 visits in random order (four period cross-over)
干预措施: Faster aspart (Drug)
结局指标
主要结局
AUC (NNC0471-0119,0-30min,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)
时间窗: 0 to 12 hours after bolus infusion
Ratio of the basal-corrected area under the serum NNC0471-0119 concentration time curve from 0 to 30 minutes and 0 to t, where t is the first time the curve is back to basal level after bolus infusion (at most 12 hours). Measured in percentage
次要结局
- AUC (NNC0471-0119,0-30min,basal-corrected)(0 to 30 minutes after bolus infusion)
- AUC (NNC0471-0119,2h-t,basal-corrected)(2 to 12 hours after bolus infusion)
- AUC (NNC0471-0119,2h-t,basal-corrected)/AUC (NNC0471-0119,0-t,basal-corrected)(0 to 12 hours after bolus infusion)
- Cmax,NNC0471-0119,basal-corrected: Maximum observed basal-corrected serum NNC0471-0119 concentration(0 to 12 hours after bolus infusion)
- AUC (NNC0471-0119,0-t,basal-corrected)(0 to 12 hours after bolus infusion)
- Number of adverse events (AEs)(From start of first investigational medicinal product ( IMP) basal rate infusion (Visit 2, day -1) until completion of post-treatment end-of-study visit (Visit 6))
- AUC (GIR,0-t,basal-corrected)(0 to 12 hours after bolus infusion)
- AUC (GIR,0-1h,basal-corrected)(0 to 1 hour after bolus infusion)
- AUC (GIR,0-1h,basal-corrected/AUC (GIR,0-t,basal-corrected)(0 to 12 hours after bolus infusion)
- GIRmax,basal-corrected: Maximum observed basal-corrected GIR(0 to 12 hours after bolus infusion)