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Safety Study to Assess Whether Proinsulin Peptide Injections Can Slow or Stop the Body Damaging Its Own Insulin-making Cells in the Pancreas in Patients Newly Diagnosed With Type 1 Diabetes

NCT01536431 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-07-28

No results posted yet for this study

Summary

The purpose of this study is to address the safety issue of whether, in patients with newly-diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely affects the rate of damage to the insulin making cells.

Conditions

Interventions

DRUG

Pro insulin peptide

Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses).

DRUG

Pro insulin peptide

Patients will receive 10 micro gr of the peptide monthly (ever 4 weeks, 6 doses) and saline injections monthly alternating with the peptide (2 weeks interval between the drug and saline).

DRUG

Saline

Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls).

Sponsors & Collaborators

  • Diabetes Vaccine Development Centre

    collaborator OTHER

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Cardiff University

    lead OTHER

Principal Investigators

  • Mark Peakman, MBBS BSc MSc PhD FRCP · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01536431 on ClinicalTrials.gov