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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

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ClinicalTrials.gov Identifier: NCT02529293
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Adocia

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.


Condition or disease Intervention/treatment Phase
Healthy Drug: BioChaperone Lispro U-100 Drug: BioChaperone Lispro U-200 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BioChaperone Lispro U-100
injection of 2 doses of 0.2 U/kg on separate visits
Drug: BioChaperone Lispro U-100
Injection of BioChaperone Lispro U-100

Experimental: BioChaperone Lispro U-200
injection of 2 doses of 0.2 U/kg on separate visits
Drug: BioChaperone Lispro U-200
Injection of BioChaperone Lispro U-200




Primary Outcome Measures :
  1. AUCLisp (0-inf) [ Time Frame: 8 hours ]
    Area under the insulin lispro serum concentration - time curve from t=0 to infinity

  2. Cmax Lisp [ Time Frame: 8 hours ]
    Maximum observed insulin lispro serum concentration


Secondary Outcome Measures :
  1. tmax Lisp [ Time Frame: 8 hours ]
    Time to maximum observed serum insulin lispro concentration

  2. AUCGIR(0-8h) [ Time Frame: 8 hours ]
    Area under the glucose infusion rate-time curve from t=0 to 8 hours

  3. GIRmax [ Time Frame: 8 hours ]
    Maximum glucose infusion rate

  4. tGIRmax [ Time Frame: 8 hours ]
    Time to maximum glucose infusion rate

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

  6. Local tolerability [ Time Frame: Up to 9 weeks ]
    Record of injection site reaction



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT02529293


Locations
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Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Grit Andersen, MD Profil Institut Für Stoffwechselfforschung GmbH
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02529293    
Other Study ID Numbers: BC3-CT012
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs