Type 1 Diabetes Mellitus
Conditions
Brief summary
Each subject will be randomly allocated to a sequence of two treatments applied at two separate dosing visits. At each dosing visit subjects will be injected with individualised doses of either BioChaperone® Combo or Humalog® Mix 25 immediately before ingesting a standardised mixed meal \[(t=0 min) start of the meal\]. Insulin doses will be identical at both dosing visits of one individual and will be administered subcutaneously in the abdominal region. Subjects will be asked to consume a standardised meal (e.g. pizza) for dinner at home in the evening before each dosing visit. Subjects will attend the clinical site in a fasted state in the morning of each dosing day and stay at the clinical trial centre until 10-hour after dosing (standardised test-meal procedure has been terminated after 6h). The two dosing visits will be separated by a wash-out period of 5-15 days.
Interventions
Subcutaneous injection of an individualized dose
DRUGHumalog® Mix25
Subcutaneous injection of an individualized dose
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
* 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. * Usual Insulin bolus dose between 0.8 and 2 (I)U per 10 g CH (both inclusive). Expecting prandial insulin dose range for standardised meal test between 5 and 12 (I)U. * BMI 18.5-28.0 kg/m\^2 (both inclusive). * HbA1c \<= 9.0% by local laboratory analysis * Fasting C-peptide \<= 0.3 nmol/L.
Exclusion criteria
* Known or suspected hypersensitivity to trial products 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, 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. * Women of child bearing potential, not willing to use contraceptive methods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta AUCBG,0-2h | 2 hours | Incremental area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BGmax | 6 hours | Maximum blood glucose concentration after a standardised meal (0-6 hours) |
| tBGmax | 6 hours | Time to maximum blood glucose concentration after a standardised meal (0-6 hours) |
| AUCLisp,0-6h, | 6 hours | Area under the plasma insulin lispro concentration-time curve from 0-6 hours |
| AUCGlarg,0-6h | 6 hours | Area under the plasma insulin glargine concentration-time curve from 0-6 hours |
| Delta AUCBG,0-6h | 6 hours | Incremental area under the blood glucose concentration-time curve from 0-6 hours after a standardised meal |
| Cmax,Glarg | 6 hours | Maximum observed plasma insulin glargine concentration |
| Adverse events | Up to 7 weeks | Number of adverse events |
| Local tolerability | Up to 7 weeks | Number and intensity of injection site reactions |
| Cmax,Lisp | 6 hours | Maximum observed plasma insulin lispro concentration |
Countries
Germany
Outcome results
None listed