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

Type1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179332
• Other study ID #: CT032-ADO02
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2017
• Last updated: December 11, 2017
• Start date: June 20, 2017
• Est. completion date: September 27, 2017

Study information

• Verified date: December 2017
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 27, 2017
• Est. primary completion date: September 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Drug:
• BioChaperone® insulin lispro
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
• Fiasp®
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
• Novorapid®
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCGIR(0-60min)	Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration	60 minutes
Secondary	AUCins(0-30min)	Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration	30 minutes
Secondary	AUCins(0-60min)	Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration	60 minutes
Secondary	AUCins(0-600min)	Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration	600 minutes
Secondary	Cmax insulin	Maximum observed baseline corrected insulin concentration	10 hours
Secondary	Tmax insulin	Time from bolus administration to baseline corrected Cmax	10 hours
Secondary	TmaxGIR	Time from bolus administration to maximum baseline corrected glucose infusion rate	10 hours
Secondary	GIRmax	Maximum baseline corrected glucose infusion rate	10 hours
Secondary	Adverse Events	Number of Adverse Events in each arm	up to 8 weeks
Secondary	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.	up to 8 weeks