Trial Outcomes & Findings for GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children (NCT NCT00886626)
NCT ID: NCT00886626
Last Updated: 2012-10-29
Results Overview
Change in body mass index (BMI) over three months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
3-month
Results posted on
2012-10-29
Participant Flow
Recruitment occurred from October 2009 - August 2010; participants were recruited from medical clinics in the Minneapolis-St. Paul area.
29 patients qualified for the study and were approached about participation. 12 agreed to participate.
Participant milestones
| Measure |
Exenatide Then Control
Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months followed by control for 3-months
|
Control Then Exenatide
No medication control for 3-months then exenatide 5 mcg for 1-month uptitrated to 10 mcg for following 2-months
|
|---|---|---|
|
Period 1 (90 Days)
STARTED
|
6
|
6
|
|
Period 1 (90 Days)
COMPLETED
|
5
|
6
|
|
Period 1 (90 Days)
NOT COMPLETED
|
1
|
0
|
|
Period 2 (90 Days)
STARTED
|
5
|
6
|
|
Period 2 (90 Days)
COMPLETED
|
5
|
6
|
|
Period 2 (90 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
All enrolled participants
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
12.7 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3-monthPopulation: Data from all participants who completed the trial were analyzed.
Change in body mass index (BMI) over three months
Outcome measures
| Measure |
Exenatide
n=11 Participants
Exenatide 5 mcg for 1-month then up-titration to 10-mcg for remaining 2-months. Participants came from period 1 and period 2.
|
Control
n=11 Participants
No medication control for 3-months. Participants came from period 1 and period 2.
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-0.9 change in kg/m^2
Standard Deviation 1.2
|
0.84 change in kg/m^2
Standard Deviation 1.3
|
Adverse Events
Exenatide
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exenatide
n=11 participants at risk
Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.
|
Control
n=11 participants at risk
No medication control for 3-months.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Number of events 4 • 6-month
Adverse Events were evaluated over length of study (6 months; 180 days)
|
0.00%
0/11 • 6-month
Adverse Events were evaluated over length of study (6 months; 180 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place