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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
Injection of BC Pram Ins
Injection of pramlintide and human insulin
Injection of lispro
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
CmaxPram
Maximum pramlintide concentration
Time frame: From 0 to 8 hours
AUCPram_0-8h
Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration
Time frame: From 0 to 8 hours
Pharmacokinetics of pramlintide
Area Under the pramlintide concentration-time Curve
Time frame: From 0 to 8 hours
Pharmacokinetics of insulins
Area Under the insulin concentration-time Curve
Time frame: From 0 to 8 hours
Glucose pharmacodynamics
Area Under the blood glucose concentration-time Curve
Time frame: From 0 to 8 hours
Safety and tolerability (Adverse Events recording)
Number of adverse events
Time frame: From 0 to 8 hours
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Injection of 0.9% NaCl