Type 1 Diabetes Mellitus
Conditions
Brief summary
This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.
Detailed description
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
Subcutaneous injection of ADO09 formulation
DRUGPlacebo
Subcutaneous injection of 0.9% NaCl
DRUGSymlin®
Subcutaneous injection of pramlintide
DRUGHumulin®
Subcutaneous injection of human insulin
DRUGHumalog®
Subcutaneous injection of insulin lispro
Sponsors
Adocia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCIns 0-8h | From 0 to 8 hours | Area under the insulin analog concentration-time curve from 0-8 hours after IMP administration |
| CmaxPram | From 0 to 8 hours | Maximum pramlintide concentration |
| AUCPram 0-8h | From 0 to 8 hours | Area under the pramlintide concentration-time curve from 0-8 hours after IMP administration |
| CmaxIns | From 0 to 8 hours | Maximum insulin analog concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of pramlintide | From 0 to 8 hours | Area under the pramlintide concentration-time curve |
| Pharmacokinetics of insulins | From 0 to 8 hours | Area under the insulins concentration-time curve |
| Glucose pharmacodynamics | From 0 to 8 hours | Area under the blood glucose concentration-time curve |
| Safety and tolerability (Adverse Events recording) | From 0 to 8 hours | Number of Adverse Events |
Countries
Germany
Outcome results
None listed