Trial Outcomes & Findings for New Onset Type 1 Diabetes: Role of Exenatide (NCT NCT01269034)
NCT ID: NCT01269034
Last Updated: 2021-08-04
Results Overview
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
COMPLETED
PHASE4
13 participants
February 2013
2021-08-04
Participant Flow
A total of 13 people in which some will be children aged 12- 18 years will participate, being diagnosed within 3 months of having been found to have type 1 diabetes.
"Each participant only received one part (A,B, or C) and did not cross over to the subsequent parts
Participant milestones
| Measure |
Part A
Exenatide and long acting insulin before the boost.
Exenatide: 1.25 mcg before the boost sub-cutaneously.
|
Part B
Rapid and long acting insulin before the boost
Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs
|
Part C
long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost
long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.
|
Healthy Controls
healthy controls without any medication before the boost.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
1
|
9
|
|
Overall Study
COMPLETED
|
0
|
2
|
1
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
New Onset Type 1 Diabetes: Role of Exenatide
Baseline characteristics by cohort
| Measure |
Part A
n=1 Participants
Exenatide and long acting insulin before the boost.
Exenatide: 1.25 mcg before the boost sub-cutaneously.
|
Part B
n=2 Participants
Rapid and long acting insulin before the boost
Rapid and long acting insulin: Depends on their Carbohydrate ratio and body needs
|
Part C
n=1 Participants
long acting insulin+ rapid acting+1.25 mcg Exenatide before the boost
long acting insulin + rapid acting + 1.25 mcg Exenatide: Depends on their body needs.
|
Healthy Controls
n=9 Participants
healthy controls without any medication before the boost.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: February 2013Population: The original PI and their entire team left the institution. Despite repeated efforts to contact the PI and study team members, the PI and study team members refused to disclose any collected data. Additionally, no secondary information sources such as study publications exist from which to summarize collected data
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: February 2013Population: The original PI and their entire team left the institution. Despite repeated efforts to contact the PI and study team members, the PI and study team members refused to disclose any collected data. Additionally, no secondary information sources such as study publications exist from which to summarize collected data.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: February 2013Population: The original PI and their entire team left the institution. Despite repeated efforts to contact the PI and study team members, the PI and study team members refused to disclose any collected data. Additionally, no secondary information sources such as study publications exist from which to summarize collected data.
Data for this outcome measure are no longer accessible; the PI has left institution and all efforts to locate the data have been exhausted.
Outcome measures
Outcome data not reported
Adverse Events
Part A
Part B
Part C
Healthy Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Roger Hicks, Administrative Director for Research - Department of Pediatrics
Albert Einstein College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place