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