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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

Primary Purpose

Type1 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BioChaperone® insulin lispro

Fiasp®

Novorapid®

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

BioChaperone® insulin lispro

Fiasp®

Novorapid®

Arm Description

Single subcutaneous administration of BioChaperone® insulin lispro

Single subcutaneous administration of Fiasp® (insulin aspart)

Single subcutaneous administration of Novorapid® (insulin aspart)

Outcomes

Primary Outcome Measures

AUCGIR(0-60min)

Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration

Secondary Outcome Measures

AUCins(0-30min)

Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration

AUCins(0-60min)

Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration

AUCins(0-600min)

Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration

Cmax insulin

Maximum observed baseline corrected insulin concentration

Tmax insulin

Time from bolus administration to baseline corrected Cmax

TmaxGIR

Time from bolus administration to maximum baseline corrected glucose infusion rate

GIRmax

Maximum baseline corrected glucose infusion rate

Adverse Events

Number of Adverse Events in each arm

Clinical safety laboratory

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.

Full Information

NCT ID

NCT03179332

First Posted

May 4, 2017

Last Updated

December 11, 2017

Sponsor

Adocia

1. Study Identification

Unique Protocol Identification Number

NCT03179332

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

June 20, 2017 (Actual)

Primary Completion Date

September 27, 2017 (Actual)

Study Completion Date

September 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Adocia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BioChaperone® insulin lispro

Arm Type

Experimental

Arm Description

Single subcutaneous administration of BioChaperone® insulin lispro

Arm Title

Fiasp®

Arm Type

Active Comparator

Arm Description

Single subcutaneous administration of Fiasp® (insulin aspart)

Arm Title

Novorapid®

Arm Type

Active Comparator

Arm Description

Single subcutaneous administration of Novorapid® (insulin aspart)

Intervention Type

Drug

Intervention Name(s)

BioChaperone® insulin lispro

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fiasp®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Novorapid®

Intervention Description

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

Primary Outcome Measure Information:

Title

AUCGIR(0-60min)

Description

Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

AUCins(0-30min)

Description

Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration

Time Frame

30 minutes

Title

AUCins(0-60min)

Description

Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration

Time Frame

60 minutes

Title

AUCins(0-600min)

Description

Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration

Time Frame

600 minutes

Title

Cmax insulin

Description

Maximum observed baseline corrected insulin concentration

Time Frame

10 hours

Title

Tmax insulin

Description

Time from bolus administration to baseline corrected Cmax

Time Frame

10 hours

Title

TmaxGIR

Description

Time from bolus administration to maximum baseline corrected glucose infusion rate

Time Frame

10 hours

Title

GIRmax

Description

Maximum baseline corrected glucose infusion rate

Time Frame

10 hours

Title

Adverse Events

Description

Number of Adverse Events in each arm

Time Frame

up to 8 weeks

Title

Clinical safety laboratory

Description

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.

Time Frame

up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oliver Klein, MD

Organizational Affiliation

Profil Institut für Stoffwechselforschung GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Profil Institut für Stoffwechselforschung GmbH

City

Neuss

ZIP/Postal Code

41460

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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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