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A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump

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ClinicalTrials.gov Identifier: NCT03179332
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Adocia

Study Description
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Brief Summary:

This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight.

Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.


Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Drug: BioChaperone® insulin lispro Drug: Fiasp® Drug: Novorapid® Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Euglycaemic Clamp Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of a Bolus Dose of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® by an Insulin Pump
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : September 27, 2017
Actual Study Completion Date : September 27, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BioChaperone® insulin lispro
Single subcutaneous administration of BioChaperone® insulin lispro
 Drug: BioChaperone® insulin lispro
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Active Comparator: Fiasp®
Single subcutaneous administration of Fiasp® (insulin aspart)
 Drug: Fiasp®
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Active Comparator: Novorapid®
Single subcutaneous administration of Novorapid® (insulin aspart)
 Drug: Novorapid®
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump


Outcome Measures
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Primary Outcome Measures :
  1. AUCGIR(0-60min) [ Time Frame: 60 minutes ]
    Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration


Secondary Outcome Measures :
  1. AUCins(0-30min) [ Time Frame: 30 minutes ]
    Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration

  2. AUCins(0-60min) [ Time Frame: 60 minutes ]
    Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration

  3. AUCins(0-600min) [ Time Frame: 600 minutes ]
    Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration

  4. Cmax insulin [ Time Frame: 10 hours ]
    Maximum observed baseline corrected insulin concentration

  5. Tmax insulin [ Time Frame: 10 hours ]
    Time from bolus administration to baseline corrected Cmax

  6. TmaxGIR [ Time Frame: 10 hours ]
    Time from bolus administration to maximum baseline corrected glucose infusion rate

  7. GIRmax [ Time Frame: 10 hours ]
    Maximum baseline corrected glucose infusion rate

  8. Adverse Events [ Time Frame: up to 8 weeks ]
    Number of Adverse Events in each arm

  9. Clinical safety laboratory [ Time Frame: up to 8 weeks ]
    Haematology, biochemistry and urinalysis: changes and findings from Baseline in clinical safety laboratory parameters during the trial duration, from screening, and at follow-up visit.


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

Inclusion Criteria:

  • Type 1 Diabetes Mellitus for more than 12 months.
  • BMI between 18.5 and 28.5 kg/m².
  • HbA1C level <=9.0%.
  • Insulin treated for at least 12 months with total insulin dose <1.2U/kg/day.

Exclusion Criteria:

  • Type 2 Diabetes Mellitus.
  • History of multiple and/or severe allergies to drugs or foods.
  • Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
  • More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
  • Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
  • Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.
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): NCT03179332


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: Oliver Klein, MD Profil Institut für Stoffwechselforschung GmbH
More Information
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT03179332    
Other Study ID Numbers: CT032-ADO02
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin Lispro
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs