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

NCT ID: NCT00058981

Last Updated: 2009-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2007-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

DiaPep277

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.
• The subject is known to test positive for HIV antibodies.
• The subject has chronic hematologic disease.
• The subject has impaired renal function (serum creatinine greater than 1.4 mg/dL).
• The subject has severe ketonuria (+++ on urine stix testing; ++ on repeated urine stix testing).
• The subject has a BMI greater than 40kg/m2.
• The subject has hyperlipidemia (fasting serum triglycerides >1000 mg/dL). Suitable medical therapy for treatment of hyperlipidemia is allowed.
• The subject has received any investigational drug within 3 months prior to Visit 1.
• The subject has had a severe blood loss (400 mL or more, e.g., blood donation) within 2 months before the first dosing of the study medication.
• The subject is a breast-feeding mother or planning to breast-feed.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DeveloGen Israel, Ltd.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Jerry P Palmer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Dana Elias, PhD

Role: STUDY_DIRECTOR

DeveloGen Israel, Ltd.

Locations

University of Alabama at Birmingham Endocrinology Department

Birmingham, Alabama, United States

University of Colorado Hospital Endocrinology Practice

Aurora, Colorado, United States

University of Kentucky Department of Internal Medicine

Lexington, Kentucky, United States

Washington University School of Medicine Endocrinology/Metabolic Dept

St Louis, Missouri, United States

North Shore Diabetes and Endocrine Associates

New Hyde Park, New York, United States

Diabetes & Glandular Disease Research Associates

San Antonio, Texas, United States

DVA Puget Sound Health Care System Endocrinology (III) Department

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24408401 (View on PubMed)

Other Identifiers

702/PO

Identifier Type: -

Identifier Source: org_study_id