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A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02029924
Recruitment Status : Completed
First Posted : January 8, 2014
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Adocia

Study Description
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Brief Summary:

The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg.

This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Drug: BioChaperone insulin lispro Drug: Humalog® Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Study Start Date : December 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: BioChaperone insulin lispro
BioChaperone insulin lispro
 Drug: BioChaperone insulin lispro
Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
Active Comparator: Humalog®
Humalog®
 Drug: Humalog®
Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)


Outcome Measures
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Primary Outcome Measures :
  1. Area under the curve (AUC) [ Time Frame: 30 minutes ]
    Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes


Secondary Outcome Measures :
  1. Pharmacokinetics: Early t0.5max(Lisp) [ Time Frame: up to 6 hours post administration of study drug ]
    Time to first observed half maximum observed insulin lispro concentration

  2. Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours [ Time Frame: 6 hours ]
  3. Glucodynamics: Early t0.5(GIRmax) [ Time Frame: 6 hours ]
    Time to first observed half maximum glucose infusion rate

  4. Glucodynamic: GIRmax (Maximum glucose infusion rate) [ Time Frame: 6 hours ]
  5. Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours [ Time Frame: 6 hours ]
  6. Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration [ Time Frame: 6 hours ]
  7. Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months.
  • Treated with multiple daily insulin injections or insulin pump for at least 12 months.
  • Body Mass Index (BMI): 18.0-28.0 Kg/m².

Exclusion Criteria:

  • Type 2 diabetes mellitus.
  • Receipt of any investigational product within 3 months prior to first dosing.
  • Clinically significant abnormalities as judged by the investigator.
  • Any systemic treatment with drugs known to interfere with glucose metabolism.
  • History of alcoholism, or drug/chemical abuse as per Investigator's judgement.
  • Use of tobacco or nicotine-contained product within 5 years prior to screening.
  • Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.
Contacts and Locations
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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): NCT02029924


Locations
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Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
More Information
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02029924    
Other Study ID Numbers: BC3-CT006
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: September 2014
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs