Trial Outcomes & Findings for Islet Transplantation for Type 1 Diabetes Mellitus (NCT NCT00437398)
NCT ID: NCT00437398
Last Updated: 2013-04-25
Results Overview
Hypoglycemia is an abnormally diminished content of glucose in the blood.
TERMINATED
PHASE1/PHASE2
2 participants
3, 6, 9, and 12 months since islet transplantation
2013-04-25
Participant Flow
Subjects were recruited from the Mayo Clinic in Rochester, Minnesota.
Three subjects were screened for islet transplantation; one subject was ineligible, being Epstein-Barr virus (EBV) seronegative.
Participant milestones
| Measure |
Islet Transplant
Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Islet Transplantation for Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Islet Transplant
n=2 Participants
Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 6, 9, and 12 months since islet transplantationPopulation: The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.
Hypoglycemia is an abnormally diminished content of glucose in the blood.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3, 6, 9, and 12 months since islet transplantationPopulation: The sample size (n=2) was too small to perform a meaningful analysis; therefore the data were not analyzed due to study termination.
HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well the subject is controlling his/her diabetes.
Outcome measures
Outcome data not reported
Adverse Events
Islet Transplant
Serious adverse events
| Measure |
Islet Transplant
n=2 participants at risk
Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
|
|---|---|
|
Infections and infestations
Hospitalization due to neutropenia and fever
|
50.0%
1/2 • Number of events 1 • Subjects were hospitalized for 48 hours for the transplant. They stayed close to hospital for 10-14 days for followup. Subjects were clinically evaluated every 3 months for the first year and annually thereafter.
|
|
Blood and lymphatic system disorders
hemodynamic instability
|
50.0%
1/2 • Number of events 1 • Subjects were hospitalized for 48 hours for the transplant. They stayed close to hospital for 10-14 days for followup. Subjects were clinically evaluated every 3 months for the first year and annually thereafter.
|
Other adverse events
| Measure |
Islet Transplant
n=2 participants at risk
Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
|
|---|---|
|
Endocrine disorders
Hypoglycemia
|
50.0%
1/2 • Number of events 2 • Subjects were hospitalized for 48 hours for the transplant. They stayed close to hospital for 10-14 days for followup. Subjects were clinically evaluated every 3 months for the first year and annually thereafter.
|
|
Injury, poisoning and procedural complications
Mild change in liver function tests
|
50.0%
1/2 • Number of events 1 • Subjects were hospitalized for 48 hours for the transplant. They stayed close to hospital for 10-14 days for followup. Subjects were clinically evaluated every 3 months for the first year and annually thereafter.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place