A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Humalog®; Drug: BC Pram Ins; Drug: Symlin® and Humulin®; Drug: Placebo

• Registration Number: NCT03512236
• Lead Sponsor: Adocia

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.

Study Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Study Start: 2018-04-25
• Study First Posted: 2018-04-30
• Status Verified: 2019-02
• Primary Completion: 2019-02-14
• Study Completion: 2019-02-14
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Humalog®	Humalog®	Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
BC Pram Ins	BC Pram Ins	Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
Humalog®	Placebo	Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy
BC Pram Ins	Placebo	Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy
Symlin® and Humulin®	Symlin® and Humulin®	Simultaneous subcutaneous injections avec pramlintide and human insulin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Pharmacokinetics of pramlintide	From 0 to 8 hours	Area Under the pramlintide concentration-time Curve

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung GmbH; 🇩🇪 Neuss, Germany