A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) 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 human insulin
Huminsulin® Normal
Humalog®
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 1
Eligibility Criteria
Inclusion Criteria:
- Male subject with type 1 diabetes for at least 12 months
- Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
- Body mass index: 18.5-28.0 kg BW·m-2
- HbA1c: ≤ 9.0%
Exclusion Criteria:
- Diabetes mellitus type 2
- Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
- 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 any tobacco or nicotine-contained product within one year prior to screening
Sites / Locations
- Profil GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
BioChaperone human insulin
Human insulin
Insulin lispro
Arm Description
BioChaperone Human Insulin
Huminsulin® Normal
Humalog®
Outcomes
Primary Outcome Measures
Area under the curve (AUCins(0-1h))
Area under the human insulin serum concentration - time curve from t=0 to 1 hour
Secondary Outcome Measures
Pharmacokinetics: Early t0.5max ins/lisp
Time to first observed half maximum serum human insulin / insulin lispro concentration
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours
Area under the glucose infusion rate - time curve from t=0 to 10 hours
Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)
Time to first observed half maximum glucose infusion rate
Glucodynamics: GIRmax - Maximum glucose infusion rate
Maximum glucose infusion rate
Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration
Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours
Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration
Time to maximum observed serum human insulin concentration and insulin lispro concentration
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Pharmacokinetics: Cmax(ins/lisp)
Maximum observed human insulin / insulin lispro serum concentration
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours
Area under the glucose infusion rate - time curve from t=0 to 2 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02213146
Brief Title
A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Official Title
A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (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 already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.
The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.
This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 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, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BioChaperone human insulin
Arm Type
Experimental
Arm Description
BioChaperone Human Insulin
Arm Title
Human insulin
Arm Type
Active Comparator
Arm Description
Huminsulin® Normal
Arm Title
Insulin lispro
Arm Type
Active Comparator
Arm Description
Humalog®
Intervention Type
Drug
Intervention Name(s)
BioChaperone human insulin
Intervention Description
Single dose of 0.2 U/kg body weight injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
Huminsulin® Normal
Intervention Description
Single dose of 0.2 U/kg body weight injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
Humalog®
Intervention Description
Single dose of 0.2 U/kg body weight injected subcutaneously
Primary Outcome Measure Information:
Title
Area under the curve (AUCins(0-1h))
Description
Area under the human insulin serum concentration - time curve from t=0 to 1 hour
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Early t0.5max ins/lisp
Description
Time to first observed half maximum serum human insulin / insulin lispro concentration
Time Frame
up to 10 hours post administration
Title
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours
Description
Area under the glucose infusion rate - time curve from t=0 to 10 hours
Time Frame
10 hours
Title
Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)
Description
Time to first observed half maximum glucose infusion rate
Time Frame
10 hours
Title
Glucodynamics: GIRmax - Maximum glucose infusion rate
Description
Maximum glucose infusion rate
Time Frame
10 hours
Title
Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration
Description
Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours
Time Frame
10 hours
Title
Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration
Description
Time to maximum observed serum human insulin concentration and insulin lispro concentration
Time Frame
10 hours
Title
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Description
Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time Frame
up to 7 weeks
Title
Pharmacokinetics: Cmax(ins/lisp)
Description
Maximum observed human insulin / insulin lispro serum concentration
Time Frame
up to 10 hours
Title
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours
Description
Area under the glucose infusion rate - time curve from t=0 to 2 hours
Time Frame
2 hours post administration
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:
Male subject with type 1 diabetes for at least 12 months
Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
Body mass index: 18.5-28.0 kg BW·m-2
HbA1c: ≤ 9.0%
Exclusion Criteria:
Diabetes mellitus type 2
Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
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 any tobacco or nicotine-contained product within one year prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grit Andersen, 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
Learn more about this trial
A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
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