A Trial Comparing the Pharmacokinetic Properties of Fast-acting Insulin Aspart Between Children, Adolescents and Adults With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
研究概览
简要总结
The study is done to compare how faster aspart is taken up, broken down and removed from the body between different age groups (children [6-11 years], adolescents [12-17 years] and adults [18-64 years]) who have diabetes. The blood sugar (glucose) lowering effect of faster aspart will also be investigated after consuming a meal replacement drink. The effects of faster aspart will be compared to the effects of NovoRapid®.
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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 6 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 6-64 years (both inclusive) at the time of signing informed consent
- •Diagnosed with type 1 diabetes greater than or equal to 12 months prior to the day of screening
- •Body mass index for children and adolescents (male and female) between the 3rd and 97th BMI percentile and for adults less than or equal to 28.0 kg/sqm
排除标准
- •Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- •Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
- •Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
研究组 & 干预措施
Faster aspart followed by insulin aspart (NovoRapid®)
Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
干预措施: Faster aspart (Drug)
Faster aspart followed by insulin aspart (NovoRapid®)
Participants will receive single dose of fast-acting insulin aspart followed by single dose of NovoRapid® on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
干预措施: Insulin aspart (NovoRapid®) (Drug)
Insulin aspart (NovoRapid®) followed by faster aspart
Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
干预措施: Faster aspart (Drug)
Insulin aspart (NovoRapid®) followed by faster aspart
Participants will receive single dose of NovoRapid® followed by single dose of fast-acting insulin aspart on two separate dosing visits. The dosing visits will be separated by a wash-out period of 3-22 days.
干预措施: Insulin aspart (NovoRapid®) (Drug)
结局指标
主要结局
AUC(IAsp),0-12h, area under the serum insulin aspart concentration-time curve from 0 to 12 hours
时间窗: 0-12 hours
Calculated based on insulin aspart measured in blood.
次要结局
- AUCIAsp,0-15min, area under the serum insulin aspart concentration-time curve 0 to 15 minutes(0-15 minutes)
- AUCIAsp,0-30min, area under the serum insulin aspart concentration-time curve from 0 to 30 minutes(0-30 minutes)
- AUCIAsp,0-1hr, area under the serum insulin aspart concentration-time curve from 0 to 1 hour(0-1 hour)
- AUCIAsp,0-1½hr, area under the serum insulin aspart concentration-time curve from 0 to 1½ hour(0-1½ hour)
- AUCIAsp,0-2hr, area under the serum insulin aspart concentration-time curve from 0 to 2 hours(0-2 hours)
- Cmax,IAsp, maximum observed serum insulin aspart concentration(0-12 hours)
- tmax,IAsp, time to maximum observed serum insulin aspart concentration(0-12 hours)
- Onset of appearanceIAsp, time from trial product administration until the first time serum insulinaspart concentration greater than or equal to Lower Limit Of Quantitation (LLOQ)(0-12 hours)
- Duration of exposureIAsp, time from trial product administration until the first time serum insulin aspart concentration is equal to LLOQ in the terminal part of the curve(0-12 hours)
- Time to 50% Cmax, IAsp, the first time point where the insulin aspart concentration equals 50% of Cmax,IAsp(0-12 hours)
- Number of adverse events(From screening day 1 up to the study completion day 68)
- Time to late 50% Cmax,IAsp, the last time point where the insulin aspart concentration equals 50% of Cmax,IAsp(0-12 hours)
- Mean change in plasma glucose concentration from 0-1 hour after administration(0-1 hour)
- Mean change in plasma glucose concentration from 0-2 hours after administration(0-2 hours)
- Mean change in plasma glucose concentration from 0-6 hours after administration(0-6 hours)
- Change from baseline in plasma glucose concentration 1 hour after administration(Pre-dose (0 hour), 1 hour)
- Change from baseline in plasma glucose concentration 2 hours after administration(Pre-dose (0 hour), 2 hours)
- Plasma glucose concentration 1 hour after administration(1 hour after administration)
- Plasma glucose concentration 2 hours after administration(2 hours after administration)
- Maximum plasma glucose excursion after administration(0-6 hours)
- Maximum plasma glucose concentration after administration(0-6 hours)
- Time to maximum plasma glucose concentration after administration(0-6 hours)
- Minimum plasma glucose concentration after administration(0-6 hours)
- Number of hypoglycaemic episodes(From screening day 1 up to the study completion day 68)