Type 1 Diabetes Mellitus
Conditions
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.
Interventions
DRUGBioChaperone Human Insulin (HinsBet®)
BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
DRUGInsulin Lispro (Humalog®)
Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
DRUGRegular human insulin (Huminsulin® Normal)
Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BG1h | 1 hour | Blood glucose (BG) concentration 1 hour after start of intake of a standardised meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCBG,0-1h | 1 hour | Area under the blood glucose concentration-time curve from 0-1 hour after 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 |
| ΔBG1h | 1 hour | Mean change from baseline of blood glucose concentration 1 hour after start of intake of a standardised meal |
| 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 |
| AUCIns,0-1h | 1 hour | Area under the serum insulin concentration-time curve from 0-1 hour |
Countries
Germany
Outcome results
None listed