Diabetes mellitus type 1 MedDRA version: 17.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Adocia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject aged 18-64 years (both inclusive). 2. Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months. 3. Treated with multiple daily insulin injections or CSII >= 12 months. 4. Current total daily insulin treatment =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to trial products or related products. 2. Type 2 diabetes mellitus. 3. Previous participation in this trial. Participation is defined as randomised. 4. The receipt of any trial product within 60 days prior to this trial. 5. Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease. 6. Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator. 7. Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption. 8. Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of postprandial blood glucose (BG) control after administration of BC222 insulin Lispro (BC Lispro) and Humalog® at the start (t=0) of a standardised meal ingestion;Secondary Objective: Comparison of the postprandial pharmacokinetic profiles of BC222 insulin lispro and Humalog® when injected after a standardized meal ;Primary end point(s): AUCBG,0-2h, area under the blood glucose concentration-time curve from 0-2 hours after a standardised meal ;Timepoint(s) of evaluation of this end point: 0-2 h after trial drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Pharmacodynamic Endpoints: • AUCBG,0-8h, area under the blood glucose concentration-time curve from 0-8 hours after a standardised meal • AUCBG,0-1h, area under the blood glucose concentration-time curve from 0-1 hours after a standardised meal • ?BGmax, maximum blood glucose excursion after a standardised meal (0-8 hours) • BGmax, maximum blood glucose concentration after a standardised meal (0-8 hours) • tBGmax, time to maximum blood glucose concentration after a standardised meal (0-8 hours) • ?BGmin, minimum blood glucose excursion after a standardised meal (0-8 hours) • BGmin, minimum blood glucose concentration after a standardised meal (0-8 hours) • BG1h, blood glucose concentration at 1 hour after a standardised meal (0-8 hours) • BG2h, blood glucose concentration at 2 hours after a standardised meal (0-8 hours) • AUCFFA,0-8h, area under the free fatty acid concentration-time curve from 0-8 hours after a standardised meal • FFAmin, minimum free fatty acid concentration after a standardised meal (0-8 hours) • tFFAmin, time to the minimum free fatty acid concentration after a standardised meal (0-8 hours) Secondary pharmacokinetic Endpoints : • AUCILisp,0-8h, area under the serum insulin lispro concentration-time curve from 0-8 hours • AUCILisp,0-30min, area under the serum insulin lispro concentration-time curve from 0-30 min • AUCILisp,0-1h, area under the serum insulin lispro concentration-time curve from 0-1 hours • AUCILisp,0-8, area under the serum insulin lispro concentration-time curve from 0 to infinity • tmax,ILisp, time to maximum observed serum insulin lispro concentration • Early t[0.5max(/Lisp)] Time to first observed half maximum serum insulin /lispro concentrations • Late t[0.5max(Lisp)] Time to last observed half maximum serum insulin lispro concentrations • Cmax,ILisp, maximum observed serum insulin lispro concentration • t1/2, ILisp, terminal half-life for insulin lispro Safet | — |
Countries
Germany
Contacts
Public ContactDeputy General Manager
Adocia
Outcome results
None listed