A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
NCT ID: NCT03512236
Last Updated: 2019-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2018-04-25
2019-02-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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BC Pram Ins
Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
BC Pram Ins
Injection of BC Pram Ins
Placebo
Injection of 0.9% NaCl
Symlin® and Humulin®
Simultaneous subcutaneous injections avec pramlintide and human insulin
Symlin® and Humulin®
Injection of pramlintide and human insulin
Humalog®
Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
Humalog®
Injection of lispro
Placebo
Injection of 0.9% NaCl
Interventions
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BC Pram Ins
Injection of BC Pram Ins
Symlin® and Humulin®
Injection of pramlintide and human insulin
Humalog®
Injection of lispro
Placebo
Injection of 0.9% NaCl
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Adocia
INDUSTRY
Responsible Party
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Principal Investigators
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Grit Andersen, MD
Role: PRINCIPAL_INVESTIGATOR
Profil Institut für Stoffwechselforschung GmbH
Locations
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Profil Institut für Stoffwechselforschung GmbH
Neuss, , Germany
Countries
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Other Identifiers
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CT031-ADO09
Identifier Type: -
Identifier Source: org_study_id
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