This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.
In this monocentric, randomised, double-blind, active comparator, controlled, cross-over trial, each patient will be randomly allocated to a sequence of three treatments: one single dose of the co-formulation of insulin analog and pramlintide (also called ADO09), simultaneous separate injections of pramlintide and human insulin and one single dose of insulin lispro. To keep the blinding in this trial, a placebo injection will be given in addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per dosing visit. During each visit, meal test procedures will be performed and subjects will stay at the clinical centre until post-dose follow-up period has been terminated. IMP administration will be done subcutaneously immediately prior to test meal intake.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
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
CmaxIns
Maximum insulin analog concentration
Time frame: From 0 to 8 hours
AUCIns 0-8h
Area under the insulin analog 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 insulins 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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Subcutaneous injection of human insulin
Subcutaneous injection of insulin lispro