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Safety, Tolerability, Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in Latent Autoimmune Diabetes in Adults (LADA)

NCT00058981 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-03-19

No results posted yet for this study

Summary

Randomized, double-blind, parallel-group study to evaluate safety and efficacy of multiple subcutaneous doses of DiaPep277 in patients with Latent Autoimmune Diabetes in Adults (LADA). Study medication will be administered at time 0, 1 and 3 months, and then every 3 months for a total of 8 administrations. The total duration of the trial is 24 months (treatment for 18 months and follow-up for an additional 6 months). Patients will be male or female between the ages of 30 and 65 years, inclusive, within 2 to 60 months of the diagnosis of diabetes mellitus. Subjects must be positive for glutamic acid decarboxylate (GAD) autoantibodies. At the Screen Visit (Visit 2), all subjects will be asked to discontinue their use of all oral antidiabetic medications with the exception of metformin. The subjects will be placed on a stable regimen of insulin and diet (plus metformin if needed). Prior to the Baseline Visit (Visit 3), diabetic control must be achieved by diet and insulin (plus metformin if needed).

Conditions

  • Diabetes, Autoimmune

Interventions

DRUG

DiaPep277

Sponsors & Collaborators

  • DeveloGen Israel, Ltd.

    lead INDUSTRY

Principal Investigators

  • Jerry P Palmer, MD · University of Washington

  • Dana Elias, PhD · DeveloGen Israel, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31
Primary Completion
2007-03-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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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 NCT00058981 on ClinicalTrials.gov