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Safety and Efficacy of BC LisPram

Type1 Diabetes Mellitus Clinical Trial

Official title:
A Randomized Controlled Pilot Study to Assess the Pharmacokinetics, Pharmacodynamics, and Closed-loop Efficacy of BC LisPram Compared to Rapid Insulin in Pump-treated Adults With Type 1 Diabetes

Clinical Trial Summary

This pilot study is a 50-hour randomized, open-label, crossover study in an inpatient setting assessing the safety, pharmacodynamics, pharmacokinetics, and closed-loop efficacy of i) BC LisPram delivery and ii) rapid insulin delivery.

Clinical Trial Description

Subjects will be randomized to intervention sequences. The first 6 participants will be randomly allocated to a sequence of three treatments composed of (i) treatment with active comparator insulin lispro, (ii) treatment with BC LisPram, and (iii) treatment with BC LisPram (dual wave bolus). The following 10 participants will be randomly allocated to a sequence of either two or three treatments. Each treatment period will last 50 hours. PK/PD assessment will be performed under an open-loop system and will be followed by a 24 hour of closed-loop assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04972175
Study type Interventional
Source Applied Medical Informatics Research Inc.
Contact Alexia Macina
Phone +1 514-623-2520
Email alexia.macina@affiliate.mcgill.ca
Status Recruiting
Phase Phase 1
Start date July 28, 2021
Completion date June 2022
View Details
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