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An Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT02660502
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : May 30, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Adocia

Brief Summary:

This is a double-blind, randomised, three period crossover phase 1 trial using automated 8-hour euglycemic clamps in healthy Japanese subjects.

Each subject will be randomly allocated to one out of nine sequences to receive either three single doses of BioChaperone insulin lispro or one single dose of Humalog® and two single doses of BioChaperone insulin lispro on three separate dosing visits.

The total trial maximum duration for a subject will be up to 10 weeks.


Condition or disease Intervention/treatment Phase
Healthy Drug: Biochaperone insulin lispro 0.1 U/kg Drug: Biochaperone insulin lispro 0.2 U/kg Drug: Biochaperone insulin lispro 0.4 U/kg Drug: Humalog® Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Comparator-controlled, Randomised, Three-period Crossover Euglycemic Clamp Trial to Evaluate Pharmacokinetics of Single Doses of BioChaperone Insulin Lispro in Healthy Japanese Subjects
Study Start Date : January 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BioChaperone insulin lispro 0.1 U/kg Drug: Biochaperone insulin lispro 0.1 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg

Experimental: BioChaperone insulin lispro 0.2 U/kg Drug: Biochaperone insulin lispro 0.2 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg

Experimental: BioChaperone insulin lispro 0.4 U/kg Drug: Biochaperone insulin lispro 0.4 U/kg
Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg

Active Comparator: Humalog® Drug: Humalog®
Injection of a single dose of Humalog® at the dose of 0.2 U/kg




Primary Outcome Measures :
  1. AUCLispro(0-30min) [ Time Frame: Up to 30 minutes ]
    Area under the insulin lispro serum concentration - time curve from t=0 to 30 minutes


Secondary Outcome Measures :
  1. AUCGIR(0-last) [ Time Frame: Up to 8 hours ]
    Area under the glucose infusion rate time curve from 0 hours until the end of clamp

  2. Adverse Events [ Time Frame: Up to 10 weeks ]
    Number of adverse events



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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese male or female subjects by completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
  • BMI between 18.5 and 25.0 kg∙m-2, both inclusive.
  • Fasting Plasma Glucose ≤ 5.6 mmol/L (100 mg/dL).
  • Signed and dated informed consent obtained before any trial-related activities.

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.
  • Any history or presence of a life threatening disease (i.e. cancer except basal cell skin cancer or squamous cell skin cancer), or of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic (including type 1 and type 2 diabetes mellitus, haematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator.
  • History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660502


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Eli Lilly and Company
Investigators
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Principal Investigator: Grit Andersen, MD Profil GmbH
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02660502    
Other Study ID Numbers: BC3-CT017
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs