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

Diabetes Mellitus Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146651
• Other study ID #: BC3-CT008
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2014
• Last updated: December 9, 2014
• Start date: May 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• BioChaperone insulin lispro 0.2U/Kg
Single dose of 0.2U/Kg body weight injected subcutaneously
• BioChaperone insulin lispro 0.1U/Kg
Single dose of 0.1U/Kg body weight injected subcutaneously
• BioChaperone insulin lispro 0.4U/Kg
Single dose of 0.4U/Kg body weight injected subcutaneously
• Humalog®
Single dose of 0.2U/Kg body weight injected subcutaneously

Locations

Country	Name	City	State
Germany	Profil Institut für stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucodynamic endpoint: Area Under the Curve GIR(0-last)	Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp	12 hours	No
Primary	Glucodynamic endpoint: GIRMax	Maximum Glucose Infusion Rate	12 hours	No
Primary	Pharmacokinetic endpoint: AUC Lisp(0-last)	Area under the insulin lispro serum concentration - time curve over the clamp procedure.	12 hours	No
Primary	Pharmacokinetic endpoint: Cmax(Lisp)	Maximum observed serum insulin lispro concentration	12 hours	No
Secondary	Pharmacokinetics: Tmax(lisp)	Time to maximum observed serum insulin lispro concentration	12 hours	No
Secondary	Glucodynamic: TGIRmax	Time to maximum Glucose Infusion Rate	12 hours	No
Secondary	Tonset of action	Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.	12 hours	No
Secondary	Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.		12 weeks	Yes