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A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus Type 1

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.4U/Kg
Humalog®
Sponsored by
Adocia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months
  • Treated with multiple daily insulin injections of insulin pump for at least 12 months
  • Body Mass Index (BMI): 18.5-28.0 Kg.m²

Exclusion Criteria:

  • Type 2 diabetes mellitus
  • Receipt of any investigational product within 3 months prior first dosing
  • Clinically significant abnormalities as judged by the investigator
  • Any systemic treatment with drugs known to interfere with glucose metabolism
  • History of alcoholism or drug/chemical abuse as per investigator's judgement
  • Use of tobacco or nicotine-contained product within 1 year prior to screening
  • Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening

Sites / Locations

  • Profil Institut für stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

BioChaperone insulin lispro 0.2U/Kg

BioChaperone insulin lispro 0.1U/Kg

BioChaperone insulin lispro 0.4U/Kg

Humalog® 0.2U/Kg

Arm Description

BioChaperone insulin lispro 0.2U/Kg

BioChaperone insulin lispro 0.1U/Kg

BioChaperone insulin lispro 0.4U/Kg

Humalog® 0.2U/Kg

Outcomes

Primary Outcome Measures

Glucodynamic endpoint: Area Under the Curve GIR(0-last)
Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp
Glucodynamic endpoint: GIRMax
Maximum Glucose Infusion Rate
Pharmacokinetic endpoint: AUC Lisp(0-last)
Area under the insulin lispro serum concentration - time curve over the clamp procedure.
Pharmacokinetic endpoint: Cmax(Lisp)
Maximum observed serum insulin lispro concentration

Secondary Outcome Measures

Pharmacokinetics: Tmax(lisp)
Time to maximum observed serum insulin lispro concentration
Glucodynamic: TGIRmax
Time to maximum Glucose Infusion Rate
Tonset of action
Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.
Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.

Full Information

First Posted
May 20, 2014
Last Updated
December 9, 2014
Sponsor
Adocia
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1. Study Identification

Unique Protocol Identification Number
NCT02146651
Brief Title
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Official Title
A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adocia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®. This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BioChaperone insulin lispro 0.2U/Kg
Arm Type
Experimental
Arm Description
BioChaperone insulin lispro 0.2U/Kg
Arm Title
BioChaperone insulin lispro 0.1U/Kg
Arm Type
Experimental
Arm Description
BioChaperone insulin lispro 0.1U/Kg
Arm Title
BioChaperone insulin lispro 0.4U/Kg
Arm Type
Experimental
Arm Description
BioChaperone insulin lispro 0.4U/Kg
Arm Title
Humalog® 0.2U/Kg
Arm Type
Active Comparator
Arm Description
Humalog® 0.2U/Kg
Intervention Type
Drug
Intervention Name(s)
BioChaperone insulin lispro 0.2U/Kg
Intervention Description
Single dose of 0.2U/Kg body weight injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
BioChaperone insulin lispro 0.1U/Kg
Intervention Description
Single dose of 0.1U/Kg body weight injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
BioChaperone insulin lispro 0.4U/Kg
Intervention Description
Single dose of 0.4U/Kg body weight injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
Humalog®
Intervention Description
Single dose of 0.2U/Kg body weight injected subcutaneously
Primary Outcome Measure Information:
Title
Glucodynamic endpoint: Area Under the Curve GIR(0-last)
Description
Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp
Time Frame
12 hours
Title
Glucodynamic endpoint: GIRMax
Description
Maximum Glucose Infusion Rate
Time Frame
12 hours
Title
Pharmacokinetic endpoint: AUC Lisp(0-last)
Description
Area under the insulin lispro serum concentration - time curve over the clamp procedure.
Time Frame
12 hours
Title
Pharmacokinetic endpoint: Cmax(Lisp)
Description
Maximum observed serum insulin lispro concentration
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Tmax(lisp)
Description
Time to maximum observed serum insulin lispro concentration
Time Frame
12 hours
Title
Glucodynamic: TGIRmax
Description
Time to maximum Glucose Infusion Rate
Time Frame
12 hours
Title
Tonset of action
Description
Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.
Time Frame
12 hours
Title
Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.
Time Frame
12 weeks

10. Eligibility

Sex
Male
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 mellitus for at least 12 months Treated with multiple daily insulin injections of insulin pump for at least 12 months Body Mass Index (BMI): 18.5-28.0 Kg.m² Exclusion Criteria: Type 2 diabetes mellitus Receipt of any investigational product within 3 months prior first dosing Clinically significant abnormalities as judged by the investigator Any systemic treatment with drugs known to interfere with glucose metabolism History of alcoholism or drug/chemical abuse as per investigator's judgement Use of tobacco or nicotine-contained product within 1 year prior to screening Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grit Andersen, MD
Organizational Affiliation
Profil Institut für Stoffwechselfforschung GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil Institut für stoffwechselforschung GmbH
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes

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