Type 1 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Monocentric, Double-blind, Multiple Daily Dose, Two-period, 14 Day Cross-over Trial to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Individualized Doses of BioChaperone Insulin Lispro in Comparison to Humalog® U-100 in Patients With Type 1 Diabetes Mellitus
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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