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
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
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
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
No
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
A
Arm Type
Experimental
Arm Description
Drug: BioChaperone® Combo
Arm Title
B
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
No
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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