DRUG
ADO09 formulation
Subcutaneous injection of ADO09 formulation
Status
Completed
Phase
Phase 1
Enrollment
24
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Subcutaneous injection of ADO09 formulation
DRUG
Subcutaneous injection of 0.9% NaCl
DRUG
Subcutaneous injection of pramlintide
DRUG
Subcutaneous injection of human insulin
DRUG
Subcutaneous injection of insulin lispro
Timeline
First posted
Apr 16, 2019
Study start
Jan 4, 2019
Primary completion
Mar 1, 2019
Study completion
Mar 1, 2019
Results posted
Not reported
Registry updated
Apr 16, 2019
Outcomes
CmaxPram
Time frame · From 0 to 8 hours
Maximum pramlintide concentration
AUCPram 0-8h
Time frame · From 0 to 8 hours
Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration
CmaxIns
Time frame · From 0 to 8 hours
Maximum insulin analog concentration
AUCIns 0-8h
Time frame · From 0 to 8 hours
Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration
Pharmacokinetics of pramlintide
Time frame · From 0 to 8 hours
Area under the pramlintide concentration-time curve
Pharmacokinetics of insulins
Time frame · From 0 to 8 hours
Area under the insulins concentration-time curve
Glucose pharmacodynamics
Time frame · From 0 to 8 hours
Area under the blood glucose concentration-time curve
Safety and tolerability (Adverse Events recording)
Time frame · From 0 to 8 hours
Number of Adverse Events
Eligibility
Inclusion Criteria: * Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months * Treated with multiple daily injection ≥ 12 months * Treated with insulin glargine U100 or U300 or insulin detemir at screening * Fasting C-peptide ≤ 0.30 nmol/L * BMI: 18.5-28.0 kg/m² (both inclusive) Exclusion Criteria: * Known or suspected hypersensitivity to IMPs, paracetamol or related products * Type 2 Diabetes Mellitus * Clinically significant abnormal haematology, biochemistry or urinalysis screening test, as judged by the investigator considering the underlying disease * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the investigator * Known slowing of gastric emptying, including gastroparesis and or gastrointestinal surgery that in the opinion of the investigator, might change gastrointestinal motility and food absorption * Intake of medication known to affect gastrointestinal motility, including but not limited to erythromycin, metoclopramide, cisapride, cholestyramine or colestipol within 4 weeks before screening
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Publications
No PMID-linked publications were present in this registry snapshot.
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