Clinical trial NCT03512236: A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
Official title: A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Adocia
Sponsor class: INDUSTRY
First posted: 2018-04-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: CmaxPram
timeFrame: From 0 to 8 hours
measure: AUCPram_0-8h
timeFrame: From 0 to 8 hours
Secondary outcomes:
measure: Pharmacokinetics of pramlintide
timeFrame: From 0 to 8 hours
measure: Pharmacokinetics of insulins
timeFrame: From 0 to 8 hours
measure: Glucose pharmacodynamics
timeFrame: From 0 to 8 hours
measure: Safety and tolerability (Adverse Events recording)
timeFrame: From 0 to 8 hours
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Grit Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: