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Completed

NCT Number: NCT03179332

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

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.

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Key information

Conditions

Type1 Diabetes Mellitus

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BioChaperone® insulin lispro

Drug

Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

Fiasp®

Drug

Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

Novorapid®

Drug

Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 7, 2017
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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