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A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Primary Purpose

Diabetes Mellitus Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BioChaperone insulin lispro

Humalog®

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 or insulin pump for at least 12 months.
Body Mass Index (BMI): 18.0-28.0 Kg/m².

Exclusion Criteria:

Type 2 diabetes mellitus.
Receipt of any investigational product within 3 months prior to 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 5 years prior to screening.
Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioChaperone insulin lispro

Humalog®

Arm Description

BioChaperone insulin lispro

Humalog®

Outcomes

Primary Outcome Measures

Area under the curve (AUC)

Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes

Secondary Outcome Measures

Pharmacokinetics: Early t0.5max(Lisp)

Time to first observed half maximum observed insulin lispro concentration

Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours

Glucodynamics: Early t0.5(GIRmax)

Time to first observed half maximum glucose infusion rate

Glucodynamic: GIRmax (Maximum glucose infusion rate)

Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours

Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration

Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

Full Information

NCT ID

NCT02029924

First Posted

December 16, 2013

Last Updated

May 31, 2017

Sponsor

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT02029924

Brief Title

A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adocia

4. Oversight

Data Monitoring Committee

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 a facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg. This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 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 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BioChaperone insulin lispro

Arm Type

Experimental

Arm Description

BioChaperone insulin lispro

Arm Title

Humalog®

Arm Type

Active Comparator

Arm Description

Humalog®

Intervention Type

Drug

Intervention Name(s)

BioChaperone insulin lispro

Intervention Description

Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

Humalog®

Intervention Description

Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

Primary Outcome Measure Information:

Title

Area under the curve (AUC)

Description

Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Pharmacokinetics: Early t0.5max(Lisp)

Description

Time to first observed half maximum observed insulin lispro concentration

Time Frame

up to 6 hours post administration of study drug

Title

Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours

Time Frame

6 hours

Title

Glucodynamics: Early t0.5(GIRmax)

Description

Time to first observed half maximum glucose infusion rate

Time Frame

6 hours

Title

Glucodynamic: GIRmax (Maximum glucose infusion rate)

Time Frame

6 hours

Title

Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours

Time Frame

6 hours

Title

Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration

Time Frame

6 hours

Title

Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

Time Frame

8 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 1 diabetes mellitus for at least 12 months. Treated with multiple daily insulin injections or insulin pump for at least 12 months. Body Mass Index (BMI): 18.0-28.0 Kg/m². Exclusion Criteria: Type 2 diabetes mellitus. Receipt of any investigational product within 3 months prior to 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 5 years prior to screening. Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.

Facility Information:

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

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