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

Overview

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.

Full Title of Study: “A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2016

Interventions

  • Drug: BioChaperone insulin lispro
    • BioChaperone insulin lispro bolus infusion followed by test meal intake
  • Drug: Humalog®
    • Humalog® bolus infusion followed by test meal intake

Arms, Groups and Cohorts

  • Experimental: BioChaperone insulin lispro
  • Active Comparator: Humalog®
    • Insulin lispro

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacodynamics: ΔAUCBG 0-2h
    • Time Frame: 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
    • Time Frame: 30 minutes
    • Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes

Secondary Measures

  • AUClis_0-6h
    • Time Frame: up to 6 Hours
    • Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose
  • Cmax
    • Time Frame: up to 6 Hours
    • Maximum insulin Concentration following a bolus dose
  • tCmax
    • Time Frame: up to 6 Hours
    • Time to Maximum insulin Concentration following a bolus dose
  • BGmax
    • Time Frame: up to 6 Hours
    • Maximum Blood Glucose after start of an individualised standardised meal intake
  • tBGmax
    • Time Frame: up to 6 Hours
    • Time to Maximum Blood Glucose concentration
  • Compatibility
    • Time Frame: up to 14 days
    • Number of suspected episodes of infusion set occlusion or leakage
  • Adverse Events
    • Time Frame: up to 12 weeks
    • Number of Adverse Events
  • Local tolerability
    • Time Frame: up to 12 weeks
    • Number of injection site reactions

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Adocia
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tim Heise, MD, Principal Investigator, Profil GmbH

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