Safety, Tolerability, Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPe… (NCT00058981) | Clinical Trial Compass
TerminatedPhase 2
Safety, Tolerability, Immunological and Clinical Efficacy of Multiple Subcutaneous Doses of DiaPep277 in Latent Autoimmune Diabetes in Adults (LADA)
United States100 participantsStarted 2002-10
Plain-language 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).
Who can participate
Age range
30 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.