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

Adocia

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Humalog®; Drug: Symlin® and Humulin®; Drug: BC Pram Ins

Study type: Interventional

Funder types: Industry

Identifiers

NCT03512236

CT031-ADO09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

BC Pram Ins

Experimental group

Description:

Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy

Treatment:

Drug: BC Pram Ins

Drug: Placebo

Symlin® and Humulin®

Active Comparator group

Description:

Simultaneous subcutaneous injections avec pramlintide and human insulin

Treatment:

Drug: Symlin® and Humulin®

Humalog®

Active Comparator group

Description:

Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy

Treatment:

Drug: Humalog®

Drug: Placebo