The Safety and Efficacy of Administrating DiaPep277® Vaccination in Type 1 Diabetes Patients.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01881958|
Recruitment Status : Withdrawn (the manufacturer decided to halt manufacturing the vaccine)
First Posted : June 20, 2013
Last Update Posted : March 6, 2018
Type 1 diabetes is caused by an autoimmune process resulting in a selective destruction of the pancreatic insulin-secreting beta-cell. DiaPep277® is a small, lyophilized powder containing 24 Amino-acids. We have proved in former studies that DiaPep277® can slow down beta cells destruction in the pancreas and therefore decelerate the progress of Diabetes.
The objective of the study is to assess the efficacy and safety of administrating DiaPep277® in type 1 diabetes patients.
|Condition or disease||Intervention/treatment||Phase|
|Type One Diabetes||Drug: DiaPep277®||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Estimated Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2017|
- efficacy will be measured by comparing Hemoglobin A1c [ Time Frame: two years ]
- Safety will be evaluated calculating number of Adverse Events. [ Time Frame: two years ]