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

NCT03512236 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-02-21

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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

Sponsors & Collaborators

  • Adocia

    lead INDUSTRY

Principal Investigators

  • Grit Andersen, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2019-02-14
Completion
2019-02-14

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03512236 on ClinicalTrials.gov