Trial Outcomes & Findings for Islet Allotransplantation With Steroid Free Immunosuppression (NCT NCT00446264)
NCT ID: NCT00446264
Last Updated: 2012-04-27
Results Overview
The percentage of insulin independents subjects with an HbA1c less than 6.5% at one year after last transplant
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
1 year
Results posted on
2012-04-27
Participant Flow
Recruitment period: 2003-2006 University Lille Hospital
Participant milestones
| Measure |
Single Arm Group
Islet Allotransplantation Group
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Islet Allotransplantation With Steroid Free Immunosuppression
Baseline characteristics by cohort
| Measure |
Single Arm Group
n=14 Participants
Islet Allotransplantation Group
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 13 • n=39 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
|
Region of Enrollment
France
|
14 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe percentage of insulin independents subjects with an HbA1c less than 6.5% at one year after last transplant
Outcome measures
| Measure |
Single Arm Group
n=14 Participants
Islet Allotransplantation Group
|
|---|---|
|
Composite Criteria: Insulin Independence and Glycosylated Hemoglobin (HbA1c) Under 6.5% at One Year
|
71 Percentage of patients
Standard Deviation 29
|
SECONDARY outcome
Timeframe: day 0 to day 365Percentage of subjects free of severe hypoglycemic events from day 0 to day 365 with the day of transplant designated day 0
Outcome measures
| Measure |
Single Arm Group
n=14 Participants
Islet Allotransplantation Group
|
|---|---|
|
Hypoglycemic Events
|
0 Percentage of patients
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 1 yearLevel of plasma C-peptide at 1 year after the first transplant
Outcome measures
| Measure |
Single Arm Group
n=14 Participants
Islet Allotransplantation Group
|
|---|---|
|
Plasma C-peptide
|
1.7 ng/ml
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 1 yearThe percentage of subjects with HbA1c \< 6.5% at 1 year after the first transplant
Outcome measures
| Measure |
Single Arm Group
n=14 Participants
Islet Allotransplantation Group
|
|---|---|
|
HbA1c < 6.5%
|
64.3 Percentage of participants
Standard Deviation 35.7
|
SECONDARY outcome
Timeframe: 1 yearpercentage of time spent in hypoglycemia derived from CGMS (Continuous Glucose Monitoring System)
Outcome measures
| Measure |
Single Arm Group
n=14 Participants
Islet Allotransplantation Group
|
|---|---|
|
Percentage of Time Spent in Hypoglycemia (<0.70 mg/L)
|
11.37 percentage of time
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: 1 yearThe number of adverse events related to the procedure and to the immunosuppression
Outcome measures
| Measure |
Single Arm Group
n=14 Participants
Islet Allotransplantation Group
|
|---|---|
|
Number of Adverse Events
|
33 number events
|
Adverse Events
Single Arm Group
Serious events: 12 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Group
n=14 participants at risk
Islet Allotransplantation Group
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
21.4%
3/14 • Number of events 5 • 1 year
|
|
Hepatobiliary disorders
choleperitonitis
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
cholestasis
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
21.4%
3/14 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Increase of creatinin
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Increase of SGPT
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
neutropenia
|
28.6%
4/14 • Number of events 11 • 1 year
|
|
Gastrointestinal disorders
Incarcerated hernia
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
hemocholecyst
|
7.1%
1/14 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
proteinuria
|
7.1%
1/14 • Number of events 2 • 1 year
|
Other adverse events
| Measure |
Single Arm Group
n=14 participants at risk
Islet Allotransplantation Group
|
|---|---|
|
Skin and subcutaneous tissue disorders
oral ulcerations
|
35.7%
5/14 • Number of events 10 • 1 year
|
|
Skin and subcutaneous tissue disorders
leg edema
|
14.3%
2/14 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
dermatosis
|
28.6%
4/14 • Number of events 4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place