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

Diabetes Mellitus Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029924
• Other study ID #: BC3-CT006
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2013
• Last updated: May 31, 2017
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2014
• Est. primary completion date: March 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 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 1
• Diabetes Mellitus, Type 1

Intervention

Drug:
• BioChaperone insulin lispro
Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
• Humalog®
Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC)	Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes	30 minutes
Secondary	Pharmacokinetics: Early t0.5max(Lisp)	Time to first observed half maximum observed insulin lispro concentration	up to 6 hours post administration of study drug
Secondary	Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours		6 hours
Secondary	Glucodynamics: Early t0.5(GIRmax)	Time to first observed half maximum glucose infusion rate	6 hours
Secondary	Glucodynamic: GIRmax (Maximum glucose infusion rate)		6 hours
Secondary	Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours		6 hours
Secondary	Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration		6 hours
Secondary	Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters		8 weeks