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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

NCT ID: NCT03179332

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2017-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Type1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BioChaperone® insulin lispro

Single subcutaneous administration of BioChaperone® insulin lispro

Group Type EXPERIMENTAL

BioChaperone® insulin lispro

Intervention Type DRUG

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

Fiasp®

Single subcutaneous administration of Fiasp® (insulin aspart)

Group Type ACTIVE_COMPARATOR

Fiasp®

Intervention Type DRUG

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

Novorapid®

Single subcutaneous administration of Novorapid® (insulin aspart)

Group Type ACTIVE_COMPARATOR

Novorapid®

Intervention Type DRUG

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

Interventions

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BioChaperone® insulin lispro

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

Intervention Type DRUG

Fiasp®

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

Intervention Type DRUG

Novorapid®

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adocia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

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Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CT032-ADO02

Identifier Type: -

Identifier Source: org_study_id