Clinical trial NCT02029924: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Area under the curve (AUC)
timeFrame: 30 minutes
Secondary outcomes:
measure: Pharmacokinetics: Early t0.5max(Lisp)
timeFrame: up to 6 hours post administration of study drug
measure: Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours
timeFrame: 6 hours
measure: Glucodynamics: Early t0.5(GIRmax)
timeFrame: 6 hours
measure: Glucodynamic: GIRmax (Maximum glucose infusion rate)
timeFrame: 6 hours
measure: Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours
timeFrame: 6 hours
measure: Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration
timeFrame: 6 hours
measure: Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
References: