Clinical trial NCT02146651: A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Official title: A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2014-05-26
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 insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.

This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus.

Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Treated with multiple daily insulin injections of insulin pump for at least 12 months
* Body Mass Index (BMI): 18.5-28.0 Kg.m²

Exclusion Criteria:

* Type 2 diabetes mellitus
* Receipt of any investigational product within 3 months prior 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 1 year prior to screening
* Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening

Primary outcomes:
measure: Glucodynamic endpoint: Area Under the Curve GIR(0-last)
timeFrame: 12 hours
measure: Glucodynamic endpoint: GIRMax
timeFrame: 12 hours
measure: Pharmacokinetic endpoint: AUC Lisp(0-last)
timeFrame: 12 hours
measure: Pharmacokinetic endpoint: Cmax(Lisp)
timeFrame: 12 hours
Secondary outcomes:
measure: Pharmacokinetics: Tmax(lisp)
timeFrame: 12 hours
measure: Glucodynamic: TGIRmax
timeFrame: 12 hours
measure: Tonset of action
timeFrame: 12 hours
measure: Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut für Stoffwechselfforschung GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: