A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Diabetes Mellitus Type 1 Clinical Trial

Official title:

A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213146
• Other study ID #: BC3-CT010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 8, 2014
• Last updated: May 31, 2017
• Start date: August 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male subject with type 1 diabetes for at least 12 months

• Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months

• Body mass index: 18.5-28.0 kg BW·m-2

• HbA1c: = 9.0%

Exclusion Criteria:

• Diabetes mellitus type 2

• Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial

• 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 any tobacco or nicotine-contained product within one year prior to screening

Related Conditions & MeSH terms

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

Intervention

Drug:
• BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously
• Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously
• Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously

Locations

Country	Name	City	State
Germany	Profil GmbH	Neuss

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 (AUCins(0-1h))	Area under the human insulin serum concentration - time curve from t=0 to 1 hour	1 hour
Secondary	Pharmacokinetics: Early t0.5max ins/lisp	Time to first observed half maximum serum human insulin / insulin lispro concentration	up to 10 hours post administration
Secondary	Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours	Area under the glucose infusion rate - time curve from t=0 to 10 hours	10 hours
Secondary	Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)	Time to first observed half maximum glucose infusion rate	10 hours
Secondary	Glucodynamics: GIRmax - Maximum glucose infusion rate	Maximum glucose infusion rate	10 hours
Secondary	Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration	Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours	10 hours
Secondary	Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration	Time to maximum observed serum human insulin concentration and insulin lispro concentration	10 hours
Secondary	Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters	Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters	up to 7 weeks
Secondary	Pharmacokinetics: Cmax(ins/lisp)	Maximum observed human insulin / insulin lispro serum concentration	up to 10 hours
Secondary	Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours	Area under the glucose infusion rate - time curve from t=0 to 2 hours	2 hours post administration