Type 1 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBC Pram Ins
Injection of BC Pram Ins
DRUGSymlin® and Humulin®
Injection of pramlintide and human insulin
DRUGHumalog®
Injection of lispro
DRUGPlacebo
Injection of 0.9% NaCl
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
* Male or female subjects aged 18-64 years (both inclusive) * Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months * Treated with multiple daily insulin injections ≥ 12 months * Treated with an evening dose of once-daily insulin glargine U100 at screening * Fasting C-peptide ≤ 0.30 nmol/L
Exclusion criteria
* Known or suspected hypersensitivity to IMPs, paracetamol (acetaminophen) or related products * Type 2 diabetes mellitus * Clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, 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 |
|---|---|---|
| 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 |
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 insulin 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