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

Primary Purpose

Diabetes, Autoimmune

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DiaPep277
Sponsored by
DeveloGen Israel, Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes, Autoimmune focused on measuring Diabetes, LADA, latent autoimmune diabetes in adults

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Subjects meeting all of the following inclusion criteria at screening should be considered for admission to the study: 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 Subjects meeting any of the following exclusion criteria at screening will not be enrolled in the study: 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.

Sites / Locations

  • University of Alabama at Birmingham Endocrinology Department
  • University of Colorado Hospital Endocrinology Practice
  • University of Kentucky Department of Internal Medicine
  • Washington University School of Medicine Endocrinology/Metabolic Dept
  • North Shore Diabetes and Endocrine Associates
  • Diabetes & Glandular Disease Research Associates
  • DVA Puget Sound Health Care System Endocrinology (III) Department

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 15, 2003
Last Updated
March 18, 2009
Sponsor
DeveloGen Israel, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00058981
Brief Title
Safety, Tolerability, Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in Latent Autoimmune Diabetes in Adults (LADA)
Official Title
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Safety and Tolerability as Well as the Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in LADA Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Study Start Date
October 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
DeveloGen Israel, Ltd.

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Autoimmune
Keywords
Diabetes, LADA, latent autoimmune diabetes in adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
DiaPep277

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects meeting all of the following inclusion criteria at screening should be considered for admission to the study: 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 Subjects meeting any of the following exclusion criteria at screening will not be enrolled in the study: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry P Palmer, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dana Elias, PhD
Organizational Affiliation
DeveloGen Israel, Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham Endocrinology Department
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Colorado Hospital Endocrinology Practice
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
University of Kentucky Department of Internal Medicine
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Washington University School of Medicine Endocrinology/Metabolic Dept
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
North Shore Diabetes and Endocrine Associates
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Diabetes & Glandular Disease Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4801
Country
United States
Facility Name
DVA Puget Sound Health Care System Endocrinology (III) Department
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24408401
Citation
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.
Results Reference
derived

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

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