Clinical trial NCT01898286: Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277®
Official title: Open-Label Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® in Subjects Who Have Completed Study 1001 (NCT01103284)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Type 1 Diabetes
Keywords: C peptide
beta cell function
immune modulation of type 1 diabetes
immune intervention in type 1 diabetes
Lead sponsor: Andromeda Biotech Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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®.

Detailed description: Treatment with DiaPep277® is expected to be long-term; stopping treatment may result in the eventual loss of the preserved beta-cell function. Indeed, extension of phase 2 studies has shown that patients who were initially treated with DiaPep277® and maintained their initial beta-cell function, required continuation of treatment, losing beta-cell function if switched to Placebo. These extension studies were too small for the outcome to be statistically significant, but they suggested that continuation of treatment is needed for long-term maintenance of efficacy.

Therefore, in this extension study, patients who complete the 1001 phase 3 study (NCT01103284) and maintain clinically significant beta-cell function are offered a 2-year continuation of active treatment, since they are likely to benefit from use of the medication. The participation in the extension study will be offered to all eligible subjects who complete the 1001 study, regardless of the treatment arm allocation in the initial study.

By achieving long-term preservation of beta-cell function, patients are expected to maintain good management of the disease, manifesting as better glycemic control and fewer hypoglycemic events.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hypoglycemic Events
timeFrame: At Early Termination Visit, Up to 25 Months
Secondary outcomes:
measure: Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit
timeFrame: Baseline and Early Termination Visit, Up to 25 Months
Other outcomes:
measure: Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit
timeFrame: Baseline and Early Termination Visit, up to 25 months
measure: Glycemic Control (Change From Baseline in % HbA1c)
timeFrame: Baseline and Early Termination Visit, Up to 25 Months
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes associates
state: Georgia
city: Detroit
country: United States
facility: Henry Ford Medical Centers - New Center One
state: Michigan
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
Study officials:
affiliation: Hadassah Medical Center, Jerusalem
name: Itamar Raz, MD
role: PRINCIPAL_INVESTIGATOR
References: