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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512236
• Other study ID #: CT031-ADO09
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2018
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2019
• Source: Adocia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Adocia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CmaxPram	Maximum pramlintide concentration	From 0 to 8 hours
Primary	AUCPram_0-8h	Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration	From 0 to 8 hours
Secondary	Pharmacokinetics of pramlintide	Area Under the pramlintide concentration-time Curve	From 0 to 8 hours
Secondary	Pharmacokinetics of insulins	Area Under the insulin concentration-time Curve	From 0 to 8 hours
Secondary	Glucose pharmacodynamics	Area Under the blood glucose concentration-time Curve	From 0 to 8 hours
Secondary	Safety and tolerability (Adverse Events recording)	Number of adverse events	From 0 to 8 hours