- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02213146
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Neuss, Germany, 41460
- Profil GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BioChaperone human insulin
BioChaperone Human Insulin
|
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
|
Active Comparator: Human insulin
Huminsulin® Normal
|
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
|
Active Comparator: Insulin lispro
Humalog®
|
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
Single dose of 0.2 U/kg body weight injected subcutaneously
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the curve (AUCins(0-1h))
Time Frame: 1 hour
|
Area under the human insulin serum concentration - time curve from t=0 to 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics: Early t0.5max ins/lisp
Time Frame: up to 10 hours post administration
|
Time to first observed half maximum serum human insulin / insulin lispro concentration
|
up to 10 hours post administration
|
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours
Time Frame: 10 hours
|
Area under the glucose infusion rate - time curve from t=0 to 10 hours
|
10 hours
|
Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)
Time Frame: 10 hours
|
Time to first observed half maximum glucose infusion rate
|
10 hours
|
Glucodynamics: GIRmax - Maximum glucose infusion rate
Time Frame: 10 hours
|
Maximum glucose infusion rate
|
10 hours
|
Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration
Time Frame: 10 hours
|
Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours
|
10 hours
|
Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration
Time Frame: 10 hours
|
Time to maximum observed serum human insulin concentration and insulin lispro concentration
|
10 hours
|
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time Frame: up to 7 weeks
|
Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
|
up to 7 weeks
|
Pharmacokinetics: Cmax(ins/lisp)
Time Frame: up to 10 hours
|
Maximum observed human insulin / insulin lispro serum concentration
|
up to 10 hours
|
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours
Time Frame: 2 hours post administration
|
Area under the glucose infusion rate - time curve from t=0 to 2 hours
|
2 hours post administration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC3-CT010
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