A 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 T1DM
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: Regular human insulin (Huminsulin® Normal)Drug: BioChaperone Human Insulin (HinsBet®)Drug: Insulin Lispro (Humalog®)
- Registration Number
- NCT02739906
- Lead Sponsor
- Adocia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Huminsulin® Normal Regular human insulin (Huminsulin® Normal) - HinsBet® BioChaperone Human Insulin (HinsBet®) - Humalog® Insulin Lispro (Humalog®) -
- Primary Outcome Measures
Name Time Method BG1h 1 hour Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal
- Secondary Outcome Measures
Name Time Method Adverse Events Up to 11 weeks Number of Adverse Events
Local tolerability (Number of injection site reactions) Up to 11 weeks Number of injection site reactions
ΔBG1h 1 hour Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal
ΔAUCBG,0-1h 1 hour Incremental area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal
AUCBG,0-1h 1 hour Area under the blood glucose concentration-time curve from 0-1 hour after a standardised meal
AUCIns,0-1h 1 hour Area under the serum insulin concentration-time curve from 0-1 hour
Trial Locations
- Locations (2)
Profil GmbH
🇩🇪Neuss, Germany
Profil Mainz GmbH & Co.KG
🇩🇪Mainz, Germany