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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT02529293
• Date of registration: 18/08/2015
• Prospective Registration: No
• Primary sponsor: Adocia
• Public title: 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
• Scientific title: 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
• Date of first enrolment: August 2015
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02529293
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Grit Andersen, MD
• Affiliation: Profil Institut Für Stoffwechselfforschung GmbH

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: BioChaperone Lispro U-200

Drug: BioChaperone Lispro U-100

Primary Outcome(s)

AUCLisp (0-inf) [Time Frame: 8 hours]

Cmax Lisp [Time Frame: 8 hours]

Secondary Outcome(s)

Local tolerability [Time Frame: Up to 9 weeks]

AUCGIR(0-8h) [Time Frame: 8 hours]

Number of Adverse events [Time Frame: Up to 9 weeks]

tmax Lisp [Time Frame: 8 hours]

GIRmax [Time Frame: 8 hours]

tGIRmax [Time Frame: 8 hours]

Secondary ID(s)

BC3-CT012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors