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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BioChaperone® insulin lispro	Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
DRUG	Fiasp®	Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
DRUG	Novorapid®	Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump

Timeline

• Start date: 2017-06-20
• Primary completion: 2017-09-27
• Completion: 2017-09-27
• First posted: 2017-06-07
• Last updated: 2017-12-12

Locations

1 site across 1 country: Germany