- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179332
A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Neuss, Germany, 41460
- Profil Institut für Stoffwechselforschung GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BioChaperone® insulin lispro
Single subcutaneous administration of 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)
|
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)
|
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCGIR(0-60min)
Time Frame: 60 minutes
|
Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUCins(0-30min)
Time Frame: 30 minutes
|
Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration
|
30 minutes
|
AUCins(0-60min)
Time Frame: 60 minutes
|
Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration
|
60 minutes
|
AUCins(0-600min)
Time Frame: 600 minutes
|
Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration
|
600 minutes
|
Cmax insulin
Time Frame: 10 hours
|
Maximum observed baseline corrected insulin concentration
|
10 hours
|
Tmax insulin
Time Frame: 10 hours
|
Time from bolus administration to baseline corrected Cmax
|
10 hours
|
TmaxGIR
Time Frame: 10 hours
|
Time from bolus administration to maximum baseline corrected glucose infusion rate
|
10 hours
|
GIRmax
Time Frame: 10 hours
|
Maximum baseline corrected glucose infusion rate
|
10 hours
|
Adverse Events
Time Frame: up to 8 weeks
|
Number of Adverse Events in each arm
|
up to 8 weeks
|
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.
|
up to 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT032-ADO02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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