Type 1 Diabetes Mellitus
Conditions
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.
Interventions
BioChaperone insulin lispro bolus infusion followed by test meal intake
DRUGHumalog®
Humalog® bolus infusion followed by test meal intake
Sponsors
Eli Lilly and Company
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| tCmax | up to 6 Hours | Time to 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 |
| AUClis_0-6h | up to 6 Hours | Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose |
| Adverse Events | up to 12 weeks | Number of Adverse Events |
| Local tolerability | up to 12 weeks | Number of injection site reactions |
| Compatibility | up to 14 days | Number of suspected episodes of infusion set occlusion or leakage |
| Cmax | up to 6 Hours | Maximum insulin Concentration following a bolus dose |
Countries
Germany
Outcome results
None listed