Trial Outcomes & Findings for Exenatide in Extreme Pediatric Obesity (NCT NCT01237197)
NCT ID: NCT01237197
Last Updated: 2014-09-12
Results Overview
As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline and 3-months
Results posted on
2014-09-12
Participant Flow
Participants were recruited from the University of Minnesota, Amplatz Children's Hospital Pediatric Weight Management Clinic in Minneapolis or the McNeely Pediatric Diabetes Center and Endocrinology Clinic, Children's Hospitals and Clinics of Minnesota in St Paul.
Participant milestones
| Measure |
Exenatide
Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
Placebo Injection
Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
|---|---|---|
|
Randomization Period
STARTED
|
13
|
13
|
|
Randomization Period
COMPLETED
|
12
|
10
|
|
Randomization Period
NOT COMPLETED
|
1
|
3
|
|
Open Label Period
STARTED
|
12
|
10
|
|
Open Label Period
COMPLETED
|
12
|
10
|
|
Open Label Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exenatide in Extreme Pediatric Obesity
Baseline characteristics by cohort
| Measure |
Exenatide
n=13 Participants
Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
Placebo Injection
n=13 Participants
Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
14.9 years
STANDARD_DEVIATION 1.76 • n=99 Participants
|
15.5 years
STANDARD_DEVIATION 1.88 • n=107 Participants
|
15.2 years
STANDARD_DEVIATION 1.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3-monthsAs results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.
Outcome measures
| Measure |
Exenatide
n=12 Participants
Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
Placebo Injection
n=10 Participants
Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
|---|---|---|
|
Percent Change From Baseline in Body Mass Index at 3-months
|
-2.9 percentage of change in BMI
Standard Deviation 1.8 • Interval -5.02 to -0.37
|
-0.15 percentage of change in BMI
Standard Deviation 3.2
|
Adverse Events
Exenatide
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Injection
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exenatide
n=13 participants at risk
Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
Placebo Injection
n=13 participants at risk
Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.
Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • Number of events 13
|
30.8%
4/13 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
30.8%
4/13 • Number of events 5
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
7.7%
1/13 • Number of events 1
|
30.8%
4/13 • Number of events 4
|
|
Nervous system disorders
Headache
|
23.1%
3/13 • Number of events 4
|
46.2%
6/13 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place