Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults (DIA-AID2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT01103284
First received: April 13, 2010
Last updated: April 19, 2016
Last verified: April 2016
Results First Received: November 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: DiaPep277
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients newly diagnosed with Type 1 diabetes were recruited at medical centers in the US, EU, Argentina, and Israel.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DiaPep277

Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.

DiaPep277: 1.0 mg dose in 0.5 mL of solution

Placebo

Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.

Placebo: 40 mg mannitol in 0.5 mL of solution.

Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months


Participant Flow:   Overall Study
    DiaPep277     Placebo  
STARTED     236     239  
Treated     236     238  
At Least One Post-baseline Visit (FAS)     233 [1]   235 [2]
COMPLETED     194     195  
NOT COMPLETED     42     44  
Death                 2                 0  
Lost to Follow-up                 9                 10  
Pregnancy                 3                 1  
Protocol Violation                 12                 5  
Adverse Event                 0                 5  
Withdrawal by Subject                 14                 18  
Dermal Hypersensitivity                 0                 1  
Termination by the Sponsor                 0                 1  
Not described                 2                 1  
Missing CRF entries for study completion                 0                 2  
[1] Patients reaching this milestone were included in the Full Analysis Set (FAS) population
[2] Patients reaching this milestone were included in the Full Analysis Set (FAS)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients randomized into the study are included in presentation of baseline results

Reporting Groups
  Description
DiaPep277

Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.

DiaPep277: 1.0 mg dose in 0.5 mL of solution

Placebo

Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.

Placebo: 40 mg mannitol in 0.5 mL of solution.

Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Total Total of all reporting groups

Baseline Measures
    DiaPep277     Placebo     Total  
Number of Participants  
[units: participants]
  236     238     474  
Age  
[units: years]
Mean (Standard Deviation)
  28.7  (6.75)     28.5  (6.56)     28.6  (6.65)  
Age, Customized  
[units: years]
Median (Full Range)
  27.0  
  (20 to 45)  
  27.0  
  (20 to 45)  
  27.0  
  (20 to 45)  
Gender  
[units: participants]
     
Female     79     73     152  
Male     157     165     322  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     224     225     449  
Hispanic     6     6     12  
Black     3     4     7  
Oriental     1     1     2  
Asian     1     0     1  
Other     0     2     2  
Unknown     1     0     1  
Daily Insulin Dose  
[units: IU/kg/day]
Mean (Standard Deviation)
  0.305  (0.1587)     0.317  (0.1649)     0.311  (0.1618)  
Fasting C-Peptide  
[units: nmol/L]
Mean (Standard Deviation)
  0.388  (0.1473)     0.407  (0.1731)     0.398  (0.1609)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months   [ Time Frame: Baseline and 24 months ]

2.  Secondary:   Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%   [ Time Frame: 24 and 25 months ]

3.  Secondary:   Frequency of Hypoglycemic Events   [ Time Frame: Baseline to 25 Months ]

4.  Secondary:   Mean Number of Days With at Least One Hypoglycemic Event   [ Time Frame: Baseline to 25 months ]

5.  Other Pre-specified:   Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study   [ Time Frame: 24 and 25 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Jeanne Novak
Organization: CBR International
phone: 7207461190
e-mail: jnovak@cbrintl.com


Publications:


Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT01103284     History of Changes
Other Study ID Numbers: DiaPep277-1001
Study First Received: April 13, 2010
Results First Received: November 16, 2015
Last Updated: April 19, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ethics Commission