A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BioChaperone Lispro U-100; Drug: BioChaperone Lispro U-200

• Registration Number: NCT02529293
• Lead Sponsor: Adocia

Brief Summary

This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
• Age ≥ 18 and ≤ 64 years, both inclusive.
• Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
• Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
• Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).

Exclusion Criteria

• Known or suspected hypersensitivity to trial product(s) or related products.
• Receipt of any investigational medicinal product within 3 months before randomisation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BioChaperone Lispro U-100	BioChaperone Lispro U-100	injection of 2 doses of 0.2 U/kg on separate visits
BioChaperone Lispro U-200	BioChaperone Lispro U-200	injection of 2 doses of 0.2 U/kg on separate visits

Primary Outcome Measures

Name	Time	Method
Cmax Lisp	8 hours	Maximum observed insulin lispro serum concentration
AUCLisp (0-inf)	8 hours	Area under the insulin lispro serum concentration - time curve from t=0 to infinity

Secondary Outcome Measures

Name	Time	Method
tmax Lisp	8 hours	Time to maximum observed serum insulin lispro concentration
AUCGIR(0-8h)	8 hours	Area under the glucose infusion rate-time curve from t=0 to 8 hours
Number of Adverse events	Up to 9 weeks	Number of adverse events
Local tolerability	Up to 9 weeks	Record of injection site reaction
GIRmax	8 hours	Maximum glucose infusion rate
tGIRmax	8 hours	Time to maximum glucose infusion rate

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany