A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®

Adocia

Status and phase

Completed

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: BioChaperone insulin lispro

Drug: Humalog®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02562313

BC3-CT015

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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