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

A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02529293

Enrollment

Registered

2015-08-20

Start date

2015-08-31

Completion date

2015-11-30

Last updated

2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBioChaperone Lispro U-100

Injection of BioChaperone Lispro U-100

DRUGBioChaperone Lispro U-200

Injection of BioChaperone Lispro U-200

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026