NCT04972175

Safety and Efficacy of BC LisPram

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Michael Tsoukas · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	50-Hour Intervention - Rapid Insulin lispro	Subcutaneous-delivery of insulin lispro using pump therapy.
DRUG	50-Hour Intervention - BC LisPram	Subcutaneous-delivery of BC LisPram using pump therapy.

Timeline

• Start date: 2021-07-28
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-07-22
• Last updated: 2022-02-16

Locations

1 site across 1 country: Canada