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A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BioChaperone® Combo

Humalog® Mix25

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

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

Inclusion Criteria:

Type 1 diabetes mellitus for at least (or equal to ) 12 months,
Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Drug: BioChaperone® Combo

Drug: Humalog® Mix25

Outcomes

Primary Outcome Measures

End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)

Secondary Outcome Measures

Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25

Number of Adverse Events

hypoglycemic events, local tolerability, adverse reactions

Full Information

NCT ID

NCT01981031

First Posted

October 31, 2013

Last Updated

May 31, 2017

Sponsor

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT01981031

Brief Title

A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

Official Title

Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2013 (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

BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro. The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg. This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Drug: BioChaperone® Combo

Arm Title

Arm Type

Active Comparator

Arm Description

Drug: Humalog® Mix25

Intervention Type

Drug

Intervention Name(s)

BioChaperone® Combo

Intervention Description

Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

Intervention Type

Drug

Intervention Name(s)

Humalog® Mix25

Intervention Description

Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

Primary Outcome Measure Information:

Title

End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)

Time Frame

from 0 to 30 hours after a single-dose administration

Secondary Outcome Measure Information:

Title

Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25

Time Frame

from 0 to 30 hours after a single-dose administration

Title

Number of Adverse Events

Description

hypoglycemic events, local tolerability, adverse reactions

Time Frame

Weeks 0-10

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 (or equal to ) 12 months, Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months, Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive) Exclusion Criteria: Type 2 diabetes mellitus, The receipt of any investigational product within 3 month 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 and any tobacco product within 5 years prior to screening Blood or plasma donation in the past month or more than 500mL within 3 months prior to screening

Facility Information:

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

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