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

Phase 1

Completed

• Conditions: Diabetes Mellitus Type 1
• Interventions: Drug: BioChaperone insulin lispro; Drug: Humalog®

• Registration Number: NCT02029924
• Lead Sponsor: Adocia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2014-03
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BioChaperone insulin lispro	BioChaperone insulin lispro	BioChaperone insulin lispro
Humalog®	Humalog®	Humalog®

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC)	30 minutes	Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Early t0.5max(Lisp)	up to 6 hours post administration of study drug	Time to first observed half maximum observed insulin lispro concentration
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours	6 hours
Glucodynamics: Early t0.5(GIRmax)	6 hours	Time to first observed half maximum glucose infusion rate
Glucodynamic: GIRmax (Maximum glucose infusion rate)	6 hours
Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours	6 hours
Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration	6 hours
Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters	8 weeks