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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BioChaperone insulin lispro
Humalog®
Sponsored by
Adocia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Profil GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioChaperone insulin lispro

Humalog®

Arm Description

Insulin lispro

Outcomes

Primary Outcome Measures

Pharmacodynamics: ΔAUCBG 0-2h
Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.
Pharmacokinetics: AUClis 0-30min
Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2015
Last Updated
November 21, 2016
Sponsor
Adocia
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02562313
Brief Title
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
Official Title
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adocia
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BioChaperone insulin lispro
Arm Type
Experimental
Arm Title
Humalog®
Arm Type
Active Comparator
Arm Description
Insulin lispro
Intervention Type
Drug
Intervention Name(s)
BioChaperone insulin lispro
Intervention Description
BioChaperone insulin lispro bolus infusion followed by test meal intake
Intervention Type
Drug
Intervention Name(s)
Humalog®
Intervention Description
Humalog® bolus infusion followed by test meal intake
Primary Outcome Measure Information:
Title
Pharmacodynamics: ΔAUCBG 0-2h
Description
Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.
Time Frame
2 Hours
Title
Pharmacokinetics: AUClis 0-30min
Description
Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
AUClis_0-6h
Description
Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose
Time Frame
up to 6 Hours
Title
Cmax
Description
Maximum insulin Concentration following a bolus dose
Time Frame
up to 6 Hours
Title
tCmax
Description
Time to Maximum insulin Concentration following a bolus dose
Time Frame
up to 6 Hours
Title
BGmax
Description
Maximum Blood Glucose after start of an individualised standardised meal intake
Time Frame
up to 6 Hours
Title
tBGmax
Description
Time to Maximum Blood Glucose concentration
Time Frame
up to 6 Hours
Title
Compatibility
Description
Number of suspected episodes of infusion set occlusion or leakage
Time Frame
up to 14 days
Title
Adverse Events
Description
Number of Adverse Events
Time Frame
up to 12 weeks
Title
Local tolerability
Description
Number of injection site reactions
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Heise, MD
Organizational Affiliation
Profil GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil GmbH
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

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

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