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

NCT00058981 | Terminated Phase 2

• 1 other identifier: 702/PO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Diabetes; LADA; latent autoimmune diabetes in adults

Interventions

DiaPep277 DRUG

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has a diagnosis of diabetes mellitus according to WHO classification for more than 2 months and less than 5 years before enrollment.
• The subject's diabetes has been controlled by diet and insulin (plus metformin if needed) for 2 or more weeks (14 days) prior to the Baseline Visit (Visit 3).
• The subject is a male or female aged 30 to 65 years. If female and not postmenopausal, the subject is not pregnant and will use effective contraceptive methods throughout the study.
• The subject is positive for GAD autoantibodies, defined as a level greater than the 99th percentile of the GAD antibody index of a normal control population for the laboratory (e.g., GAD antibody index equal to 0.085).
• The subject has a fasting C-peptide level 0.30 nmol/L or greater or 0.9 ng/mL at the time of the Screen Visit (Visit 1 or 2).

You may not qualify if:

• The subject has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the site investigator, are likely to affect the subject's response to treatment or their ability to complete the study.
• The subject has a history of any kind of malignant tumor.
• The subject has secondary diabetes mellitus.
• Within 2 weeks or 14 days of the Baseline Visit or during randomized treatment, the subject takes an oral anti-diabetic medication other than metformin to treat his/her diabetes.
• The subject has clinical evidence of any diabetes-related complication that in the opinion of the site investigator would interfere with the subject's participation in and/or completion of the study.
• The subject has a history of allergy or asthma that in the opinion of the site investigator would interfere with the subject's participation in and completion of the study.
• The subject has a known immune deficiency from any disease, or a condition associated with an immune deficiency.
• The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication that, in the opinion of the site investigator, might interfere with the study.
• The subject is a pregnant woman or a woman who is planning to become pregnant.
• The subject has any of the following:
• chronic hepatitis or liver cirrhosis, or any other chronic liver disease
• is known to test positive for hepatitis B antigens or hepatitis C antibodies
• has abnormal liver function, defined as serum AST or ALT 3 times or more the upper limit of normal
• The subject is a known or suspected drug abuser.
• The subject has influenza-like symptoms on the day of dosing.

Sponsors & Collaborators

• DeveloGen Israel, Ltd.: lead

Study Sites (7)

University of Alabama at Birmingham Endocrinology Department

Birmingham, Alabama, 35294, United States

Location

University of Colorado Hospital Endocrinology Practice

Aurora, Colorado, 80010, United States

Location

University of Kentucky Department of Internal Medicine

Lexington, Kentucky, 40536, United States

Location

Washington University School of Medicine Endocrinology/Metabolic Dept

St Louis, Missouri, 63110, United States

Location

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, 11042, United States

Location

Diabetes & Glandular Disease Research Associates

San Antonio, Texas, 78229-4801, United States

Location

DVA Puget Sound Health Care System Endocrinology (III) Department

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Pozzilli P, Raz I, Peled D, Elias D, Avron A, Tamir M, Eren R, Dagan S, Cohen IR. Evaluation of long-term treatment effect in a type 1 diabetes intervention trial: differences after stimulation with glucagon or a mixed meal. Diabetes Care. 2014;37(5):1384-91. doi: 10.2337/dc13-1392. Epub 2014 Jan 9.

  PMID: 24408401 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Latent Autoimmune Diabetes in Adults

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jerry P Palmer, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Dana Elias, PhD

  DeveloGen Israel, Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 15, 2003
• First Posted: April 24, 2003
• Study Start: October 1, 2002
• Primary Completion: March 1, 2007
• Study Completion: May 1, 2007
• Last Updated: March 19, 2009

Record last verified: 2009-03

Locations

US (7)