This is a double-blind, randomised, controlled, two-period crossover phase Ib trial using an individualised standard meal with a fixed nutrient ratio in subjects with type 2 diabetes mellitus to investigate post-prandial blood glucose control with BioChaperone insulin lispro compared to insulin lispro (Humalog®, Eli Lilly and Company) before and after a period of multiple daily dose administrations for 14 days. Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-BioChaperone insulin lispro. Injections will take place immediately before an individualised standard meal in the morning of day 1, 2, 13, and 14. Insulin doses will be determined at the screening visit. During the outpatient phase the subjects will keep their basal insulin constant (except changes for safety reason). They will self-measure blood glucose at least 4 times daily (pre-prandial and at bedtime). In addition, on two days per outpatient period (Day 5 and 9) blood glucose will be measured 7 times daily (pre-prandial, 2 hours post-prandial and at bedtime).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
51
Injection immediately before the start of the individualised standard meal
Injection immediately before the start of the individualised standard meal
Profil Mainz GmbH & Co.KG
Mainz, Germany
Profil GmbH
Neuss, Germany
Pharmacodynamics: ΔAUCBG 0-2h
Incremental Area Under Blood Glucose concentration-time Curve from 0-2 hours after a meal (comparison between BioChaperone insulin lispro and insulin lispro)
Time frame: 2 hours
Pharmacokinetics: AUClis 0-30min
Area Under the serum insulin Lispro concentration-time Curve 0-30 minutes (comparison between BioChaperone insulin lispro and insulin lispro)
Time frame: 30 minutes
AUClisp_0-6h
Area Under the serum insulin Lispro concentration-time Curve from 0-6 hours after bolus dose
Time frame: up to 6 hours
Cmax_lisp
Maximum serum insulin lispro Concentration
Time frame: up to 6 hours
tmax_lisp
Time to maximum observed serum insulin lispro concentration
Time frame: up to 6 hours
CmaxBG
Maximum Blood Glucose after an individualised standard meal
Time frame: up to 6 hours
AUCBG_0-6h
Area Under the Curve under the Blood Glucose concentration time curve from 0-6 hours
Time frame: up to 6 hours
Adverse Events
Number of Adverse Events
Time frame: up to 8 weeks
Local tolerability
Record of injection site reaction
Time frame: up to 8 weeks
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