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
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2014-08-11
Enrollment: 38
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 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.


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

Primary outcomes:
measure: Area under the curve (AUCins(0-1h))
timeFrame: 1 hour
Secondary outcomes:
measure: Pharmacokinetics: Early t0.5max ins/lisp
timeFrame: up to 10 hours post administration
measure: Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours
timeFrame: 10 hours
measure: Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)
timeFrame: 10 hours
measure: Glucodynamics: GIRmax - Maximum glucose infusion rate
timeFrame: 10 hours
measure: Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration
timeFrame: 10 hours
measure: Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration
timeFrame: 10 hours
measure: Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
timeFrame: up to 7 weeks
measure: Pharmacokinetics: Cmax(ins/lisp)
timeFrame: up to 10 hours
measure: Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours
timeFrame: 2 hours post administration
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil GmbH
Study officials:
affiliation: Profil GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: