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

Sponsor

Adocia (Industry)

Overall Status

Completed

CT.gov ID

NCT03512236

Collaborator

(none)

Enrollment

Location

Arms

9.7

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Drug: BC Pram Ins Drug: Symlin® and Humulin® Drug: Humalog® Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 25, 2018

Actual Primary Completion Date :

Feb 14, 2019

Actual Study Completion Date :

Feb 14, 2019

Arms and Interventions

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: Humalog® Injection of lispro Drug: Placebo Injection of 0.9% NaCl

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: Humalog®

Injection of lispro

Drug: Placebo

Injection of 0.9% NaCl

Outcome Measures

Primary Outcome Measures

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

Pharmacokinetics of pramlintide [From 0 to 8 hours]
Area Under the pramlintide concentration-time Curve
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Profil Institut für Stoffwechselforschung GmbH	Neuss		Germany

Sponsors and Collaborators

Adocia

Investigators

Principal Investigator: Grit Andersen, MD, Profil Institut für Stoffwechselforschung GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adocia

ClinicalTrials.gov Identifier:

NCT03512236

Other Study ID Numbers:

CT031-ADO09

First Posted:

Apr 30, 2018

Last Update Posted:

Feb 21, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Insulin Lispro

Study Results

No Results Posted as of Feb 21, 2019