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Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients (DIA-AID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier:
NCT00615264
First received: February 4, 2008
Last updated: May 25, 2016
Last verified: May 2016
Results First Received: November 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 1 Diabetes
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
No text entered.

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

DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.

DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months

Placebo

Mannitol 40 mg in 0.5 mL lipid emulsion.

Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.


Participant Flow:   Overall Study
    DiaPep277     Placebo  
STARTED     225     232  
Received at Least One Dose (ITT)     225     231  
ITT Patients Who Met Inc/Excl (MITT)     209     213  
COMPLETED     175     180  
NOT COMPLETED     50     52  
Withdrawal by Subject                 17                 19  
Lost to Follow-up                 6                 13  
Adverse Event                 8                 5  
Death                 1                 1  
Protocol Violation                 11                 7  
Not defined                 7                 4  
Dermal Hypersensitivity                 0                 3  



  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.
No text entered.

Reporting Groups
  Description
DiaPep277

DiaPep277 1.0 mg + 40 mg Mannitol in 0.5mL Lipid emulsion.

DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months

Placebo

Mannitol 40 mg in 0.5 mL Lipid emulsion.

Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.

Total Total of all reporting groups

Baseline Measures
    DiaPep277     Placebo     Total  
Number of Participants  
[units: participants]
  225     231     456  
Age  
[units: years]
Mean (Standard Deviation)
  26.6  (7.99)     26.4  (7.85)     26.5  (7.91)  
Age, Customized  
[units: years]
Median (Full Range)
  25.0  
  (15 to 46)  
  26.0  
  (15 to 46)  
  25.0  
  (15 to 46)  
Gender  
[units: participants]
     
Female     83     73     156  
Male     142     158     300  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     212     212     424  
Black     6     7     13  
Oriental     2     1     3  
Asian     1     4     5  
Other     4     7     11  



  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:   Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months   [ Time Frame: Baseline and 24 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT00615264     History of Changes
Other Study ID Numbers: 901
ISRCTN55429664
Study First Received: February 4, 2008
Results First Received: November 16, 2015
Last Updated: May 25, 2016
Health Authority: Austria: Federal Ministry for Health and Women
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Israel: The Israel National Institute for Health Policy Research and Health Services Research
Italy: Ministry of Health
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration