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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Injection at t0,or t+15 minutes or t-15minutes with test meal
Injection at t0,or t+15 minutes or t-15minutes with test meal
Profil GmbH
Neuss, Germany
AUCΔBG0-2h (timepoint 0 = administration of the meal)
Incremental area under the blood glucose (BG) concentration-time curve from 0-2 hours after a meal on day 1-3 \[comparison between treatments Biochaperone insulin lispro vs. lispro (Humalog®)\]
Time frame: 2 hours
AUClispro 0-30min (timepoint 0 = time of dosing)
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®))
Time frame: 30 minutes
AUClispro_0-6h
Area under the serum insulin lispro concentration-time curve from 0-6 hours after bolus dose
Time frame: 6 Hours
Cmax_lispro
Maximum serum insulin lispro concentration
Time frame: up to 6 Hours
Tmax_lispro
Time to maximum observed serum insulin lispro concentration
Time frame: up to 6 Hours
AUCBG_0-6h
Area under the curve under the blood glucose (BG) concentration time curve from 0-6 hours
Time frame: 6 Hours
ΔBGmax
Maximum blood glucose (BG) excursion after a standard meal (0-6 hours)
Time frame: 6 Hours
Adverse events
Number of Adverse events
Time frame: Up to 3 months
Local tolerability injection site reactions
Injection site reactions over 14 days of exposure
Time frame: 14 days
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