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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: BC Pram Ins; Drug: Placebo; Drug: Symlin® and Humulin®; Drug: Humalog®

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany
    • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BC Pram Ins; Single subcutaneous injection of BC Pram Ins + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: BC Pram Ins; Injection of BC Pram Ins; Drug: Placebo; Injection of 0.9% NaCl
ACTIVE_COMPARATOR: Symlin® and Humulin®; Simultaneous subcutaneous injections avec pramlintide and human insulin	Drug: Symlin® and Humulin®; Injection of pramlintide and human insulin
ACTIVE_COMPARATOR: Humalog®; Single subcutaneous injection of lispro + injection of placebo (0.9% NaCl) to ensure the double dummy	Drug: Placebo; Injection of 0.9% NaCl; Drug: Humalog®; Injection of lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CmaxPram	Maximum pramlintide concentration	From 0 to 8 hours
AUCPram_0-8h	Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration	From 0 to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of pramlintide	Area Under the pramlintide concentration-time Curve	From 0 to 8 hours
Pharmacokinetics of insulins	Area Under the insulin concentration-time Curve	From 0 to 8 hours
Glucose pharmacodynamics	Area Under the blood glucose concentration-time Curve	From 0 to 8 hours
Safety and tolerability (Adverse Events recording)	Number of adverse events	From 0 to 8 hours

Collaborators and Investigators

• Sponsor: Adocia

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2018
• Primary Completion (ACTUAL): February 14, 2019
• Study Completion (ACTUAL): February 14, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (ACTUAL): April 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: CT031-ADO09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No