Skip to main content
OpenTrials
Completed

NCT Number: NCT02562313

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioChaperone insulin lispro

Drug

BioChaperone insulin lispro bolus infusion followed by test meal intake

Humalog®

Drug

Humalog® bolus infusion followed by test meal intake

Primary outcomes

  1. 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.

  2. Pharmacokinetics: AUClis 0-30min

    Time frame: 30 minutes

    Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes

Secondary outcomes

  1. AUClis_0-6h

    Time frame: up to 6 Hours

    Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose

  2. Cmax

    Time frame: up to 6 Hours

    Maximum insulin Concentration following a bolus dose

  3. tCmax

    Time frame: up to 6 Hours

    Time to Maximum insulin Concentration following a bolus dose

  4. BGmax

    Time frame: up to 6 Hours

    Maximum Blood Glucose after start of an individualised standardised meal intake

  5. tBGmax

    Time frame: up to 6 Hours

    Time to Maximum Blood Glucose concentration

  6. Compatibility

    Time frame: up to 14 days

    Number of suspected episodes of infusion set occlusion or leakage

  7. Adverse Events

    Time frame: up to 12 weeks

    Number of Adverse Events

  8. Local tolerability

    Time frame: up to 12 weeks

    Number of injection site reactions

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2015
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.