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 | Completed Phase 1

• 1 other identifier: BC3-CT012
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCLisp (0-inf)

  Area under the insulin lispro serum concentration - time curve from t=0 to infinity

  8 hours

• Cmax Lisp

  Maximum observed insulin lispro serum concentration

  8 hours

Secondary Outcomes (6)

• tmax Lisp

  8 hours

• AUCGIR(0-8h)

  8 hours

• GIRmax

  8 hours

• tGIRmax

  8 hours

• Number of Adverse events

  Up to 9 weeks

Study Arms (2)

BioChaperone Lispro U-100

ACTIVE COMPARATOR

injection of 2 doses of 0.2 U/kg on separate visits

Drug: BioChaperone Lispro U-100

BioChaperone Lispro U-200

EXPERIMENTAL

injection of 2 doses of 0.2 U/kg on separate visits

Drug: BioChaperone Lispro U-200

Interventions

BioChaperone Lispro U-100 DRUG

Injection of BioChaperone Lispro U-100

BioChaperone Lispro U-100

BioChaperone Lispro U-200 DRUG

Injection of BioChaperone Lispro U-200

BioChaperone Lispro U-200

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Study Officials

• Grit Andersen, MD

  Profil Institut Für Stoffwechselfforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

DE (1)