DRUG
BC Pram Ins
Injection of BC Pram Ins
Status
Completed
Phase
Phase 1
Enrollment
24
Locations
1
Results
Not posted
Publications
0
Study 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.
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
DRUG
Injection of BC Pram Ins
DRUG
Injection of pramlintide and human insulin
DRUG
Injection of lispro
DRUG
Injection of 0.9% NaCl
Timeline
First posted
Apr 30, 2018
Study start
Apr 25, 2018
Primary completion
Feb 14, 2019
Study completion
Feb 14, 2019
Results posted
Not reported
Registry updated
Feb 21, 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
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 insulin 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: * 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
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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