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

• Status: Completed
• Trial end date: 2019-02-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adocia
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc; Islet Amyloid Polypeptide; Pramlintide

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