A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Adocia
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- BG1h
研究概览
简要总结
This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.
Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.
Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.
The total trial duration for an individual subject will be up to 11 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject aged 18-64 years (both inclusive).
- •Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
- •Treated with multiple daily insulin injections or CSII >= 12 months.
- •Current total daily insulin treatment < 1.2 (I)U/kg/day.
- •Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
- •BMI 18.5-28.0 kg/m^2 (both inclusive).
- •HbA1c <= 9.0 % by local laboratory analysis
- •Fasting C-peptide <= 0.30 nmol/L.
排除标准
- •Known or suspected hypersensitivity to IMPs or related products.
- •Type 2 diabetes mellitus.
- •Previous participation in this trial. Participation is defined as randomised.
- •Participation in any clinical trial within 3 months prior to this trial.
- •Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
- •Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
- •Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the Investigator might change gastrointestinal motility and food absorption.
- •Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods
研究组 & 干预措施
HinsBet®
干预措施: BioChaperone Human Insulin (HinsBet®) (Drug)
Humalog®
干预措施: Insulin Lispro (Humalog®) (Drug)
Huminsulin® Normal
干预措施: Regular human insulin (Huminsulin® Normal) (Drug)
结局指标
主要结局
BG1h
时间窗: 1 hour
Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal
次要结局
- Adverse Events(Up to 11 weeks)
- Local tolerability (Number of injection site reactions)(Up to 11 weeks)
- ΔBG1h(1 hour)
- ΔAUCBG,0-1h(1 hour)
- AUCBG,0-1h(1 hour)
- AUCIns,0-1h(1 hour)