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Trial record 11 of 331 for:    C-peptide | "Diabetes Mellitus, Insulin-Dependent"

Intravenous CTLA4-lg Treatment in Recent Onset Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00505375
Recruitment Status : Completed
First Posted : July 23, 2007
Results First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Juvenile Diabetes Research Foundation
American Diabetes Association
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Drug: CTLA-4 Ig
Other: Placebo
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CTLA-4 Ig Placebo
Hide Arm/Group Description

Intravenous infusions of CTLA-4 Ig

CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses

Intravenous infusions of placebo

Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses

Period Title: Overall Study
Started 77 35
Completed 73 30
Not Completed 4 5
Reason Not Completed
Death             1             0
Withdrawal by Subject             2             2
Lost to Follow-up             0             2
Pregnancy             1             0
Travel issues             0             1
Arm/Group Title CTLA-4 Ig Placebo Total
Hide Arm/Group Description

Intravenous infusions of CTLA-4 Ig

CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses

Intravenous infusions of placebo

Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses

Total of all reporting groups
Overall Number of Baseline Participants 77 35 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 35 participants 112 participants
13.9  (6.9) 13.7  (5.3) 13.9  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 35 participants 112 participants
Female
36
  46.8%
10
  28.6%
46
  41.1%
Male
41
  53.2%
25
  71.4%
66
  58.9%
1.Primary Outcome
Title Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit
Time Frame 2 years of follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CTLA-4 Ig Placebo
Hide Arm/Group Description:
Intravenous infusions 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
Overall Number of Participants Analyzed 73 30
Geometric Mean (95% Confidence Interval)
Unit of Measure: nmol/L
0.375
(0.290 to 0.465)
0.266
(0.171 to 0.368)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CTLA-4 Ig, Placebo
Comments The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the “AUC mean” and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CTLA-4 Ig Placebo
Hide Arm/Group Description

Intravenous infusions of CTLA-4 Ig

CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses

Intravenous infusions of placebo

Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses

All-Cause Mortality
CTLA-4 Ig Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CTLA-4 Ig Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/77 (14.29%)      7/35 (20.00%)    
Blood and lymphatic system disorders     
Hemoglobin  1  0/77 (0.00%)  0 1/35 (2.86%)  1
Leukocytes (total WBC)  1  0/77 (0.00%)  0 1/35 (2.86%)  1
Neutrophils/granulocytes (ANC/AGC)  1  0/77 (0.00%)  0 1/35 (2.86%)  1
Endocrine disorders     
Endocrine - Other  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Pancreatic endocrine: glucose intolerance  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal - Other  1  3/77 (3.90%)  3 3/35 (8.57%)  3
Vomiting  1  0/77 (0.00%)  0 1/35 (2.86%)  1
General disorders     
Insomnia  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Death not associated with CTCAE term  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Pain- Head/headache  1  0/77 (0.00%)  0 1/35 (2.86%)  1
Secondary Malignancy - possibly related to cancer treatment  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Syndromes - Other  1  0/77 (0.00%)  0 1/35 (2.86%)  1
Metabolism and nutrition disorders     
Glucose, serum-high (hyperglycemia)  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Glucose, serum-low (hypoglycemia)  1  3/77 (3.90%)  5 1/35 (2.86%)  2
Musculoskeletal and connective tissue disorders     
Fracture  1  2/77 (2.60%)  2 0/35 (0.00%)  0
Nervous system disorders     
Mood alteration- Agitation  1  0/77 (0.00%)  0 1/35 (2.86%)  1
Seizure  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other  1  1/77 (1.30%)  1 1/35 (2.86%)  1
Surgical and medical procedures     
Intra-operative Injury - Other  1  1/77 (1.30%)  1 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CTLA-4 Ig Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/77 (77.92%)      26/35 (74.29%)    
Blood and lymphatic system disorders     
Neutrophils/granulocytes (ANC/AGC)  1  9/77 (11.69%)  14 5/35 (14.29%)  12
Endocrine disorders     
Endocrine - Other  1  5/77 (6.49%)  5 1/35 (2.86%)  1
Gastrointestinal disorders     
Dental: teeth  1  5/77 (6.49%)  5 1/35 (2.86%)  1
Gastrointestinal - Other  1  5/77 (6.49%)  5 2/35 (5.71%)  2
Vomiting  1  12/77 (15.58%)  16 4/35 (11.43%)  4
General disorders     
Constitutional Symptoms - Other  1  5/77 (6.49%)  6 1/35 (2.86%)  1
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  8/77 (10.39%)  9 1/35 (2.86%)  1
Other AE  1  4/77 (5.19%)  4 1/35 (2.86%)  1
Pain- Head/headache  1  1/77 (1.30%)  1 2/35 (5.71%)  2
Pain - Other  1  2/77 (2.60%)  3 3/35 (8.57%)  4
Flu-like syndrome  1  7/77 (9.09%)  7 4/35 (11.43%)  4
Infections and infestations     
Infection - Other  1  28/77 (36.36%)  58 13/35 (37.14%)  23
Infection with unknown ANC- Pharynx  1  1/77 (1.30%)  1 3/35 (8.57%)  3
Musculoskeletal and connective tissue disorders     
Fracture  1  9/77 (11.69%)  12 5/35 (14.29%)  5
Musculoskeletal/Soft Tissue - Other  1  6/77 (7.79%)  7 3/35 (8.57%)  3
Nervous system disorders     
Neuropathy: sensory  1  0/77 (0.00%)  0 2/35 (5.71%)  2
Respiratory, thoracic and mediastinal disorders     
Bronchospasm, wheezing  1  1/77 (1.30%)  1 2/35 (5.71%)  4
Cough  1  1/77 (1.30%)  1 2/35 (5.71%)  4
Pulmonary/Upper Respiratory - Other  1  8/77 (10.39%)  14 2/35 (5.71%)  2
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other  1  12/77 (15.58%)  14 1/35 (2.86%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Carla Greenbaum
Organization: Benaroya Research Institute
Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00505375     History of Changes
Other Study ID Numbers: CTLA (IND)
First Submitted: July 20, 2007
First Posted: July 23, 2007
Results First Submitted: May 12, 2016
Results First Posted: August 16, 2016
Last Update Posted: August 16, 2016