Current partner codePEPTIDESDE
NCT03512236·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

24

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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.

Interventions

Treatment arms and agents.

DRUG

BC Pram Ins

Injection of BC Pram Ins

DRUG

Symlin® and Humulin®

Injection of pramlintide and human insulin

DRUG

Humalog®

Injection of lispro

DRUG

Placebo

Injection of 0.9% NaCl

Timeline

From registration to results.

  1. First posted

    Apr 30, 2018

  2. Study start

    Apr 25, 2018

  3. Primary completion

    Feb 14, 2019

  4. Study completion

    Feb 14, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Feb 21, 2019

Outcomes

What the study measures.

Primary outcomes

CmaxPram

Time frame · From 0 to 8 hours

Maximum pramlintide concentration

AUCPram_0-8h

Time frame · From 0 to 8 hours

Area Under the pramlintide concentration-time Curve from 0-8 hours after IMP administration

Secondary outcomes

Pharmacokinetics of pramlintide

Time frame · From 0 to 8 hours

Area Under the pramlintide concentration-time Curve

Pharmacokinetics of insulins

Time frame · From 0 to 8 hours

Area Under the insulin concentration-time Curve

Glucose pharmacodynamics

Time frame · From 0 to 8 hours

Area Under the blood glucose concentration-time Curve

Safety and tolerability (Adverse Events recording)

Time frame · From 0 to 8 hours

Number of adverse events

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
64 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.