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Trial record 10 of 330 for:    C-peptide | "Diabetes Mellitus, Insulin-Dependent"

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

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: NCT00615264
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Andromeda Biotech Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: DiaPep277
Drug: Placebo
Enrollment 457
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DiaPep277 Placebo
Hide Arm/Group Description

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

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.

Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title DiaPep277 Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 225 231 456
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 225 participants 231 participants 456 participants
26.6  (7.99) 26.4  (7.85) 26.5  (7.91)
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 225 participants 231 participants 456 participants
25.0
(15 to 46)
26.0
(15 to 46)
25.0
(15 to 46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 225 participants 231 participants 456 participants
Female
83
  36.9%
73
  31.6%
156
  34.2%
Male
142
  63.1%
158
  68.4%
300
  65.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 225 participants 231 participants 456 participants
Caucasian 212 212 424
Black 6 7 13
Oriental 2 1 3
Asian 1 4 5
Other 4 7 11
1.Primary Outcome
Title Change From Baseline in Glucagon-stimulated C-peptide AUC at 24 Months
Time Frame Baseline and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) Population - all randomized patients who received at least one dose of study medication and who entered the study according to the definition of the target population, as defined by the inclusion and exclusion criteria in the study protocol
Arm/Group Title DiaPep277 Placebo
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 209 213
Mean (Standard Error)
Unit of Measure: nmol*minute/L
-3.848  (0.4666) -4.348  (0.4584)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DiaPep277, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2851
Comments [Not Specified]
Method Mixed Models Analysis
Comments Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix
2.Secondary Outcome
Title Change From Baseline in Mixed-meal Stimulated C-peptide AUC at 24 Months
Hide Description Beta cell function, measured as stimulated C-peptide secretion from 0 to 120 min post administration AUC, at baseline and 24 month measurements in a mixed-meal tolerance test (MMTT). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.
Time Frame Baseline and 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent to Treat (MITT) Population
Arm/Group Title DiaPep277 Placebo
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 209 213
Mean (Standard Error)
Unit of Measure: nmol*minute/L
-44.33  (3.6884) -43.24  (3.5898)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DiaPep277, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7690
Comments [Not Specified]
Method Mixed Models Analysis
Comments Calculated with terms for treatment, visit, treatment by visit interaction, baseline C-peptide and country with the unstructured option for the matrix
Time Frame AE data were collected from the time of subject enrollment through three months after the final product administrations (Total of 24 months after first study product administration)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DiaPep277 Placebo
Hide Arm/Group Description

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

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.

All-Cause Mortality
DiaPep277 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DiaPep277 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   26/225 (11.56%)   14/231 (6.06%) 
Blood and lymphatic system disorders     
Neutropenia *  0/225 (0.00%)  1/231 (0.43%) 
Gastrointestinal disorders     
Diverticulitis *  1/225 (0.44%)  0/231 (0.00%) 
Gastritis Viral *  1/225 (0.44%)  0/231 (0.00%) 
Gastroenteritis *  0/225 (0.00%)  1/231 (0.43%) 
Hepatobiliary disorders     
Cholelithiasis *  1/225 (0.44%)  0/231 (0.00%) 
Hepatitis *  1/225 (0.44%)  0/231 (0.00%) 
Infections and infestations     
Bronchopneumomnia *  1/225 (0.44%)  0/231 (0.00%) 
Infection *  1/225 (0.44%)  0/231 (0.00%) 
Influenza *  1/225 (0.44%)  0/231 (0.00%) 
Urinary Tract Infection *  0/225 (0.00%)  1/231 (0.43%) 
Injury, poisoning and procedural complications     
Laceration *  1/225 (0.44%)  0/231 (0.00%) 
Metabolism and nutrition disorders     
Diabetic Ketoacidosis *  4/225 (1.78%)  2/231 (0.87%) 
Hypoglycaemia *  2/225 (0.89%)  2/231 (0.87%) 
Hypoglycemic Coma *  1/225 (0.44%)  1/231 (0.43%) 
Hyperglycemia *  1/225 (0.44%)  0/231 (0.00%) 
Type 1 Diabetes Mellitus *  0/225 (0.00%)  1/231 (0.43%) 
Musculoskeletal and connective tissue disorders     
Jaw Fracture *  1/225 (0.44%)  0/231 (0.00%) 
Wrist Fracture *  1/225 (0.44%)  0/231 (0.00%) 
Ligament Rupture *  0/225 (0.00%)  1/231 (0.43%) 
Nervous system disorders     
Concussion *  0/225 (0.00%)  1/231 (0.43%) 
Head Injury *  0/225 (0.00%)  1/231 (0.43%) 
Facial Paresis *  1/225 (0.44%)  0/231 (0.00%) 
Loss of Consciousness *  1/225 (0.44%)  0/231 (0.00%) 
Migraine *  1/225 (0.44%)  0/231 (0.00%) 
Psychiatric disorders     
Accidental Overdose *  1/225 (0.44%)  1/231 (0.43%) 
Major Depression *  1/225 (0.44%)  1/231 (0.43%) 
Alcohol Poisoning *  1/225 (0.44%)  0/231 (0.00%) 
Mental Disorder *  1/225 (0.44%)  0/231 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis *  1/225 (0.44%)  0/231 (0.00%) 
Renal Colic *  1/225 (0.44%)  0/231 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchiectasis *  1/225 (0.44%)  0/231 (0.00%) 
Nasal Septum Deviation *  1/225 (0.44%)  0/231 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema Nodosum *  1/225 (0.44%)  0/231 (0.00%) 
Henoch-Schonlein Purpura *  0/225 (0.00%)  1/231 (0.43%) 
Urticaria Cholinergic *  0/225 (0.00%)  1/231 (0.43%) 
Social circumstances     
Death * [1]  1/225 (0.44%)  0/231 (0.00%) 
Death * [2]  0/225 (0.00%)  1/231 (0.43%) 
*
Indicates events were collected by non-systematic assessment
[1]
This patient had an unspecified event leading to their death. The Investigator confirmed that the death certificate and autopsy results were unobtainable.
[2]
In the placebo group a male patient's wife became pregnant with twins. Both were live births, but one died shortly after due to an intracranial hemorrhage, which was reported in the database within the placebo group
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
DiaPep277 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   173/225 (76.89%)   164/231 (71.00%) 
Blood and lymphatic system disorders     
Anemia *  2/225 (0.89%)  5/231 (2.16%) 
Cardiac disorders     
Cardiac Disorders *  0/225 (0.00%)  9/231 (3.90%) 
Endocrine disorders     
Endocrine Disorders *  7/225 (3.11%)  2/231 (0.87%) 
Eye disorders     
Eye Disorders *  6/225 (2.67%)  5/231 (2.16%) 
Gastrointestinal disorders     
Nausea *  8/225 (3.56%)  6/231 (2.60%) 
Gastritis *  8/225 (3.56%)  3/231 (1.30%) 
Toothache *  7/225 (3.11%)  3/231 (1.30%) 
Diarrhea *  7/225 (3.11%)  2/231 (0.87%) 
Vomiting *  5/225 (2.22%)  7/231 (3.03%) 
Abdominal Pain Upper *  3/225 (1.33%)  5/231 (2.16%) 
General disorders     
Pyrexia *  10/225 (4.44%)  11/231 (4.76%) 
Injection Site Erythema *  9/225 (4.00%)  3/231 (1.30%) 
Injection Site Pain *  8/225 (3.56%)  8/231 (3.46%) 
Injection Site Induration *  5/225 (2.22%)  3/231 (1.30%) 
Immune system disorders     
Immune System Disorders *  3/225 (1.33%)  6/231 (2.60%) 
Infections and infestations     
Nasopharyngitis *  37/225 (16.44%)  41/231 (17.75%) 
Influenza *  30/225 (13.33%)  23/231 (9.96%) 
Upper respiratory Tract Infection *  23/225 (10.22%)  19/231 (8.23%) 
Gastroenteritis *  14/225 (6.22%)  17/231 (7.36%) 
Pharyngitis *  8/225 (3.56%)  7/231 (3.03%) 
Tonsillitis *  7/225 (3.11%)  6/231 (2.60%) 
Urinary Tract Infection *  6/225 (2.67%)  9/231 (3.90%) 
Bronchitis *  6/225 (2.67%)  8/231 (3.46%) 
Sinusitis *  6/225 (2.67%)  8/231 (3.46%) 
Cystitis *  6/225 (2.67%)  1/231 (0.43%) 
Respiratory Tract Infection *  5/225 (2.22%)  6/231 (2.60%) 
Injury, poisoning and procedural complications     
Injury, Poisoning and Procedural Complications *  28/225 (12.44%)  19/231 (8.23%) 
Investigations     
Blood Creatine Phosphokinase Increased *  6/225 (2.67%)  9/231 (3.90%) 
Alanine Aminotransferase Increased *  5/225 (2.22%)  3/231 (1.30%) 
Glycosylated Haemoglobin Increased *  3/225 (1.33%)  7/231 (3.03%) 
Metabolism and nutrition disorders     
Hypercholesterolemia *  2/225 (0.89%)  7/231 (3.03%) 
Musculoskeletal and connective tissue disorders     
Back Pain *  10/225 (4.44%)  9/231 (3.90%) 
Nervous system disorders     
Headache *  12/225 (5.33%)  12/231 (5.19%) 
Dizziness *  5/225 (2.22%)  1/231 (0.43%) 
Psychiatric disorders     
Psychiatric disorders *  8/225 (3.56%)  6/231 (2.60%) 
Renal and urinary disorders     
Renal and Urinary Disorders *  10/225 (4.44%)  4/231 (1.73%) 
Reproductive system and breast disorders     
Reproductive System and Breast Disorders *  8/225 (3.56%)  7/231 (3.03%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic and Mediastinal Disorders *  14/225 (6.22%)  14/231 (6.06%) 
Skin and subcutaneous tissue disorders     
Skin and Subcutaneous Tissue Disorders *  26/225 (11.56%)  21/231 (9.09%) 
Vascular disorders     
Hypertension *  3/225 (1.33%)  6/231 (2.60%) 
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Dr. Jeanne Novak
Organization: CBR International
Phone: 7207461190
Responsible Party: Andromeda Biotech Ltd.
ClinicalTrials.gov Identifier: NCT00615264     History of Changes
Other Study ID Numbers: 901
ISRCTN55429664
First Submitted: February 4, 2008
First Posted: February 14, 2008
Results First Submitted: November 16, 2015
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016