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

Phase 2

Completed

• Conditions: Diabetes Mellitus Type 1
• Interventions: Drug: BioChaperone insulin lispro 0.2U/Kg; Drug: BioChaperone insulin lispro 0.1U/Kg; Drug: BioChaperone insulin lispro 0.4U/Kg; Drug: Humalog®

• Registration Number: NCT02146651
• 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-09
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BioChaperone insulin lispro 0.1U/Kg	Humalog®	BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.4U/Kg	BioChaperone insulin lispro 0.4U/Kg	BioChaperone insulin lispro 0.4U/Kg
Humalog® 0.2U/Kg	BioChaperone insulin lispro 0.4U/Kg	Humalog® 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg	BioChaperone insulin lispro 0.1U/Kg	BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.1U/Kg	BioChaperone insulin lispro 0.2U/Kg	BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg	BioChaperone insulin lispro 0.1U/Kg	BioChaperone insulin lispro 0.1U/Kg
Humalog® 0.2U/Kg	BioChaperone insulin lispro 0.2U/Kg	Humalog® 0.2U/Kg
BioChaperone insulin lispro 0.4U/Kg	BioChaperone insulin lispro 0.2U/Kg	BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg	Humalog®	BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.2U/Kg	BioChaperone insulin lispro 0.2U/Kg	BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg	BioChaperone insulin lispro 0.4U/Kg	BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg	Humalog®	BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.1U/Kg	BioChaperone insulin lispro 0.4U/Kg	BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.4U/Kg	BioChaperone insulin lispro 0.1U/Kg	BioChaperone insulin lispro 0.4U/Kg
Humalog® 0.2U/Kg	BioChaperone insulin lispro 0.1U/Kg	Humalog® 0.2U/Kg
Humalog® 0.2U/Kg	Humalog®	Humalog® 0.2U/Kg

Primary Outcome Measures

Name	Time	Method
Glucodynamic endpoint: Area Under the Curve GIR(0-last)	12 hours	Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp
Glucodynamic endpoint: GIRMax	12 hours	Maximum Glucose Infusion Rate
Pharmacokinetic endpoint: AUC Lisp(0-last)	12 hours	Area under the insulin lispro serum concentration - time curve over the clamp procedure.
Pharmacokinetic endpoint: Cmax(Lisp)	12 hours	Maximum observed serum insulin lispro concentration

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Tmax(lisp)	12 hours	Time to maximum observed serum insulin lispro concentration
Glucodynamic: TGIRmax	12 hours	Time to maximum Glucose Infusion Rate
Tonset of action	12 hours	Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.
Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.	12 weeks

Trial Locations

Locations (1)

Profil Institut für stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany