A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Drug: BioChaperone insulin lispro
- Registration Number
- NCT02562313
- Lead Sponsor
- Adocia
- Brief Summary
This study is constituted of 2 parts:
Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including:
* Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the post-prandial glucose response for 6 hours after individualized standard meal (fixed nutrient ratio) ingestion and bolus administration via CSII.
* Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode (i.e. neither subjects nor the investigators are aware of the sensor glucose values).
* Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the Investigational Medicinal Products (IMP) during the outpatient periods.
Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed.
Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Type 1 diabetes for at least 12 months
- Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
- Using or having used a Roche CSII system (Accu-Chek® Spirit Combo/ Accu- Chek® Spirit) for at least 6 months before screening. In Part B subjects using any form of CSII treatment for at least 6 months before screening will be included.
- HbA1c <= 9.0%.
- Total insulin dose of < 1.2 (I)U/kg/day
- Ability to calculate insulin bolus manually or using a bolus calculator and willingness to consume regular meals, perform carbohydrate counting, self-monitoring of plasma glucose (SMPG) profiles and use of Continuous Glucose Monitoring (CGM).
- Fasting C-peptide <= 0.30 nmol/L
- Known or suspected hypersensitivity to Investigational Medicinal Product(s) (IMP(s)) or related products
- Type 2 diabetes mellitus
- Previous participation in this trial.
- Receipt of any investigational product in a clinical trial within 60 days before randomisation in this trial
- Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening test
- Presence of clinically significant acute gastrointestinal symptoms
- Known slowing of gastric emptying and or gastrointestinal surgery
- Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the trial
- History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening
- History of abscess at the infusion site within 6 months prior to screening
- Hypoglycaemia unawareness as judged by the Investigator
- History of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Humalog® Humalog® Insulin lispro BioChaperone insulin lispro BioChaperone insulin lispro -
- Primary Outcome Measures
Name Time Method Pharmacodynamics: ΔAUCBG 0-2h 2 Hours Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.
Pharmacokinetics: AUClis 0-30min 30 minutes Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes
- Secondary Outcome Measures
Name Time Method Compatibility up to 14 days Number of suspected episodes of infusion set occlusion or leakage
tCmax up to 6 Hours Time to Maximum insulin Concentration following a bolus dose
AUClis_0-6h up to 6 Hours Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose
Cmax up to 6 Hours Maximum insulin Concentration following a bolus dose
BGmax up to 6 Hours Maximum Blood Glucose after start of an individualised standardised meal intake
tBGmax up to 6 Hours Time to Maximum Blood Glucose concentration
Adverse Events up to 12 weeks Number of Adverse Events
Local tolerability up to 12 weeks Number of injection site reactions
Trial Locations
- Locations (1)
Profil GmbH
🇩🇪Neuss, Germany