Type 1 Diabetes Mellitus
Conditions
Brief summary
This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. The assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes). Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be performed during the 14 day treatment periods.
Interventions
Injection at t0,or t+15 minutes or t-15minutes with test meal
DRUGHumalog®
Injection at t0,or t+15 minutes or t-15minutes with test meal
Sponsors
Eli Lilly and Company
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 (no pump users) ≥ 12 months * Current total daily insulin treatment \<1.2 (I)U/kg/day * Body mass index (BMI) 18.5-28.0 kg/m² (both inclusive) * HbA1c (N-(1-deoxy)-fructosyl-haemoglobin) ≤ 9.0% by local laboratory analysis * Fasting C-peptide ≤ 0.30 nmol/L
Exclusion criteria
* Known or suspected hypersensitivity to trial products or related products * Type 2 diabetes mellitus * Patients using continuous subcutaneous insulin infusion (CSII) * Previous participation in this trial. Participation is defined as randomised * The receipt of any investigational product 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCΔBG0-2h (timepoint 0 = administration of the meal) | 2 hours | Incremental area under the blood glucose (BG) concentration-time curve from 0-2 hours after a meal on day 1-3 \[comparison between treatments Biochaperone insulin lispro vs. lispro (Humalog®)\] |
| AUClispro 0-30min (timepoint 0 = time of dosing) | 30 minutes | Area under the serum insulin lispro concentration-time curve from 0-30 minutes after bolus dose on one of days 1, 2 or 3 (comparison between treatments BioChaperone insulin lispro vs. lispro (Humalog®)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax_lispro | up to 6 Hours | Time to maximum observed serum insulin lispro concentration |
| AUCBG_0-6h | 6 Hours | Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours |
| AUClispro_0-6h | 6 Hours | Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose |
| Adverse events | Up to 3 months | Number of Adverse events |
| Local tolerability injection site reactions | 14 days | Injection site reactions over 14 days of exposure |
| ΔBGmax | 6 Hours | Maximum blood glucose (BG) excursion after a standard meal (0-6 hours) |
| Cmax_lispro | up to 6 Hours | Maximum serum insulin lispro concentration |
Countries
Germany
Outcome results
None listed