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Diabetes, AutoimmunePhase 2NCT00058981

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

A Phase 2 study testing DiaPep277 in people with Diabetes, Autoimmune, run by DeveloGen Israel, Ltd. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Diabetes, Autoimmune
What is being tested?
DiaPep277
How many people
100 participants
Where
7 sitesUnited States
Study dates
Oct 2002to May 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Colorado Hospital Endocrinology Practice

    Aurora, Colorado, 80010

  • University of Alabama at Birmingham Endocrinology Department

    Birmingham, Alabama, 35294

  • University of Kentucky Department of Internal Medicine

    Lexington, Kentucky, 40536

  • North Shore Diabetes and Endocrine Associates

    New Hyde Park, New York, 11042

  • Diabetes & Glandular Disease Research Associates

    San Antonio, Texas, 78229-4801

  • DVA Puget Sound Health Care System Endocrinology (III) Department

    Seattle, Washington, 98108

  • Washington University School of Medicine Endocrinology/Metabolic Dept

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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).

Being tested
DiaPep277
Keywords
Diabetes, LADA, latent autoimmune diabetes in adults
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Latent Autoimmune Diabetes in Adults

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiaPep277Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2003 (estimated)
  2. Study startOct 2002
  3. Primary completionMar 2007
  4. Study completionMay 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00058981
Sponsor's protocol ID
702/PO
Status last verified
Mar 2009
First submitted
15 Apr 2003
Last updated
19 Mar 2009
Results posted
No

Publications

  • 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.

    PubMed 24408401

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DiaPep277 in people with Diabetes, Autoimmune, run by DeveloGen Israel, Ltd. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00058981, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.

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