Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®

Stopped early · Phase 3

Conditions studied: Type 1 Diabetes

In brief

This is an extension study to evaluate the safety and tolerability of long-term treatment with DiaPep277® and to determine the long-term treatment effect of DiaPep277® on parameters of metabolic control and on preservation of beta-cell function in subjects who have long exposure to DiaPep277®.

Key facts

Study ID

NCT01898286

Run by

Andromeda Biotech Ltd.

People needed

38

Starts

2013-10-01

Expected to finish

2014-12-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older, up to 47. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients with type 1 diabetes who participated in the 1001 study
• residual beta-cell function demonstrated by stimulated C-peptide ≥ 0.20 nmol/L.

You may not qualify if…

• The subject has any significant ongoing diseases or conditions that is likely to affect the subject's response to treatment
• The subject has a history of any kind of malignant tumor.
• The subject has clinical evidence of any diabetes-related complication
• Subject has history of endogenous allergic reactivity:
• The subject has a known immune deficiency

Where it is running

• Atlanta Diabetes associates — Atlanta, Georgia, United States
• Henry Ford Medical Centers - New Center One — Detroit, Michigan, United States
• Mountain Diabetes and Endocrine Center — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.