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A Phase III Study to Investigate the Impact of Diamyd in Patients Newly Diagnosed With Type 1 Diabetes (USA)- DIAPREVENT

NCT00751842 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2012-10-10

No results posted yet for this study

Summary

The intended purpose of this study was to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

Based on results from other clinical trials with the study drug it was judged unlikely this study would meet the intended primary or secondary efficacy endpoints. Therefore the primary focus of this study was changed to ensure that safety data was available for at least 6 months following the last dose of active study drug. Thereafter the study was terminated.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

rhGAD65

Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1, 30, 90 and 270.

DRUG

rhGAD65

Diamyd (rhGAD65) 20 µg injected subcutaneously at days 1 and 30, followed by placebo injections at days 90 and 270.

DRUG

Placebo

Placebo injected subcutaneously at days 1, 30, 90 and 270.

Sponsors & Collaborators

  • Diamyd Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Jerry Palmer, Professor · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • United States

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 NCT00751842 on ClinicalTrials.gov