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Trial record 80 of 339 for:    C-peptide | "Diabetes Mellitus, Insulin-Dependent"

Open-Label Extension Study to Evaluate Long Term Safety and Treatment Effect of DiaPep277® (DIA-AID 2)

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ClinicalTrials.gov Identifier: NCT01898286
Recruitment Status : Terminated (A corporate decision to suspend development of DiaPep277®)
First Posted : July 12, 2013
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Intervention Drug: DiaPep277®
Enrollment 38
Recruitment Details Patients diagnosed with Type 1 diabetes mellitus up to six months before randomization to Study 1001 (NCT01103284), from medical sites in the EU, US, Russia, and Israel
Pre-assignment Details  
Arm/Group Title Patients Treated With DiaPep (Originally Enrolled in Study1001
Hide Arm/Group Description All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Period Title: Overall Study
Started 38
Completed 35 [1]
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             1
Lost to Follow-up             1
[1]
For this study "completed" is defined as completing the Early Termination visit
Arm/Group Title Patients Treated With DiaPep (Originally Enrolled in Study1001
Hide Arm/Group Description All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants
33.16  (7.343)
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 38 participants
32.00
(23.0 to 47.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
11
  28.9%
Male
27
  71.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
Caucasian 33
Hispanic 1
Black 3
Asian 1
1.Primary Outcome
Title Hypoglycemic Events
Hide Description The number of hypoglycemic events recorded by each patient over the course of the study.
Time Frame At Early Termination Visit, Up to 25 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with hypoglycemic event data at the time of their early termination visit. This population is smaller than the population numbers in the patient flow categories because not all patients were willing to provide information on hypoglycemic events at early termination.
Arm/Group Title Patients Treated With DiaPep (Originally Enrolled in Study1001
Hide Arm/Group Description:
All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: hypoglycemic events
3.3  (3.30)
2.Secondary Outcome
Title Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit
Time Frame Baseline and Early Termination Visit, Up to 25 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 9 patients had sufficient data for this analysis, as many patients declined to undergo the GST at the termination visit.
Arm/Group Title Patients Treated With DiaPep (Originally Enrolled in Study1001
Hide Arm/Group Description:
All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: nmol*minute/L
0.2  (2.334)
3.Other Pre-specified Outcome
Title Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit
Hide Description [Not Specified]
Time Frame Baseline and Early Termination Visit, up to 25 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with daily insulin dose data at baseline and their early termination visit. Only 11 patients could be included in this analysis, as not all patients provided insulin dose data at their early termination visit.
Arm/Group Title Patients Treated With DiaPep (Originally Enrolled in Study1001
Hide Arm/Group Description:
All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: IU/kg
0.025  (0.0270)
4.Other Pre-specified Outcome
Title Glycemic Control (Change From Baseline in % HbA1c)
Hide Description [Not Specified]
Time Frame Baseline and Early Termination Visit, Up to 25 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with % HbA1c data at baseline and their early termination visit. Only 5 patients were available for this analysis, as not all patients agreed to complete HbA1c testing at the early termination visit.
Arm/Group Title Patients Treated With DiaPep (Originally Enrolled in Study1001
Hide Arm/Group Description:
All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: % HbA1c
0.46  (0.907)
Time Frame AE data were collected from the time of subject enrollment through each subject's early termination visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Treated With DiaPep (Originally Enrolled in Study1001
Hide Arm/Group Description All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
All-Cause Mortality
Patients Treated With DiaPep (Originally Enrolled in Study1001
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients Treated With DiaPep (Originally Enrolled in Study1001
Affected / at Risk (%)
Total   1/38 (2.63%) 
Immune system disorders   
Anaphylaxic shock for glucagon * 1  1/38 (2.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Patients Treated With DiaPep (Originally Enrolled in Study1001
Affected / at Risk (%)
Total   9/38 (23.68%) 
Blood and lymphatic system disorders   
Pancytopenia * 1  1/38 (2.63%) 
General disorders   
Injection site erythema * 1  1/38 (2.63%) 
Non-cardiac chest pain * 1  1/38 (2.63%) 
Infections and infestations   
Nasopharyngitis * 1  2/38 (5.26%) 
Influenza * 1  1/38 (2.63%) 
Urinary tract infection * 1  1/38 (2.63%) 
Injury, poisoning and procedural complications   
Contusion * 1  1/38 (2.63%) 
Investigations   
Electrocardiogram QT prolonged * 1  2/38 (5.26%) 
Blood cholesterol increased * 1  1/38 (2.63%) 
Low density lipoprotein increased * 1  1/38 (2.63%) 
Urine albumin/creatinine ratio increased * 1  1/38 (2.63%) 
Nervous system disorders   
Syncope * 1  1/38 (2.63%) 
Psychiatric disorders   
Anxiety * 1  1/38 (2.63%) 
Social phobia * 1  1/38 (2.63%) 
Renal and urinary disorders   
Dysuria * 1  1/38 (2.63%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
The objectives of this study were to evaluate the safety and tolerability of long term treatment with DiaPep277. The study was terminated by the Sponsor on 08Sep14; hence many of the protocol-specified objectives could not be adequately assessed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator shall submit any paper or presentation to the Sponsor for review and comments at least 60 days prior to submitting the same to a third party. Upon receiving any request from the Sponsor to delete any Confidential Information or request to delay in publication up to 90 days to allow the filing of any Sponsor application, the Investigator shall take the request action. Investigator shall not be restricted after 18 months from completion of their site's performance in the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jeanne Novak
Organization: CBR International
Phone: 7207461190
EMail: jnovak@cbrintl.com
Layout table for additonal information
Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT01898286     History of Changes
Other Study ID Numbers: 1010
2013-002775-17 ( EudraCT Number )
First Submitted: July 10, 2013
First Posted: July 12, 2013
Results First Submitted: November 16, 2015
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016