NCT03512236

A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Adocia · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus.

Detailed description

This is a single center, randomised, double-blind, active comparator controlled, three-period cross-over, single dose trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to a sequence of three treatments:(i) simultaneous administrations of BioChaperone® pramlintide human insulin (BC Pram Ins) and placebo, (ii) simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®) and (iii) simultaneous injections of insulin lispro (Humalog®) and placebo. Subjects will come in a fasted state to the clinical trial centre in the morning, meal test procedures will be performed and subjects will stay at the clinical trial centre until the post-dose follow-up period has been terminated.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	BC Pram Ins	Injection of BC Pram Ins
DRUG	Symlin® and Humulin®	Injection of pramlintide and human insulin
DRUG	Humalog®	Injection of lispro
DRUG	Placebo	Injection of 0.9% NaCl

Timeline

• Start date: 2018-04-25
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2018-04-30
• Last updated: 2019-02-21

Locations

1 site across 1 country: Germany