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

NCT02529293 — Phase 1, Completed, 26 participants, Adocia

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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

Registry	NCT02529293
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: triple, treatment
Enrollment	26 (Actual)
Sponsor	Adocia (Industry)
Conditions	Healthy
Interventions	BioChaperone Lispro U-100, BioChaperone Lispro U-200 (Drug)
Dates	start 2015-08-01, primary completion 2015-11-01, completion 2015-11-01, first posted 2015-08-20, last updated 2015-12-18
Locations	1 site in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
BioChaperone Lispro U-100	Active comparator	Drug: BioChaperone Lispro U-100	injection of 2 doses of 0.2 U/kg on separate visits
BioChaperone Lispro U-200	Experimental	Drug: BioChaperone Lispro U-200	injection of 2 doses of 0.2 U/kg on separate visits

BioChaperone Lispro U-100 (Drug): Injection of BioChaperone Lispro U-100
BioChaperone Lispro U-200 (Drug): Injection of BioChaperone Lispro U-200

+Outcome measures

Primary outcomes

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 outcomes

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
GIRmax [8 hours]: Maximum glucose infusion rate
tGIRmax [8 hours]: Time to maximum glucose infusion rate
Number of Adverse events [Up to 9 weeks]: Number of adverse events
Local tolerability [Up to 9 weeks]: Record of injection site reaction

+Eligibility

Sex: All, ages: 18 Years to 64 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Profil Institut für Stoffwechselforschung GmbH	Neuss	Germany

+Investigators

Grit Andersen, MD, Principal investigator, Profil Institut Für Stoffwechselfforschung GmbH