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Exenatide in Extreme Pediatric Obesity

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ClinicalTrials.gov Identifier: NCT01237197
Recruitment Status : Completed
First Posted : November 9, 2010
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Collaborator:
Children's Hospitals and Clinics of Minnesota
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: Exenatide
Drug: Placebo
Enrollment 26
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Exenatide Placebo Injection
Hide Arm/Group Description

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 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.

Period Title: Randomization Period
Started 13 13
Completed 12 10
Not Completed 1 3
Period Title: Open Label Period
Started 12 10
Completed 12 10
Not Completed 0 0
Arm/Group Title Exenatide Placebo Injection Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
13
 100.0%
13
 100.0%
26
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
14.9  (1.76) 15.5  (1.88) 15.2  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
8
  61.5%
8
  61.5%
16
  61.5%
Male
5
  38.5%
5
  38.5%
10
  38.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title Percent Change From Baseline in Body Mass Index at 3-months
Hide Description As results are measured by BMI reduction, percent change (reduction) in BMI is primary outcome measure.
Time Frame Baseline and 3-months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo Injection
Hide Arm/Group Description:

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 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.

Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: percentage of change in BMI
-2.9  (1.8) -0.15  (3.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Placebo Injection
Hide Arm/Group Description

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 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.

All-Cause Mortality
Exenatide Placebo Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exenatide Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/13 (92.31%)      12/13 (92.31%)    
Gastrointestinal disorders     
Nausea *  8/13 (61.54%)  13 4/13 (30.77%)  4
Vomiting *  4/13 (30.77%)  5 1/13 (7.69%)  1
Diarrhea *  1/13 (7.69%)  1 4/13 (30.77%)  4
Nervous system disorders     
Headache *  3/13 (23.08%)  4 6/13 (46.15%)  6
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Aaron S. Kelly, Ph.D.
Organization: University of Minnesota
Phone: 612-626-3492
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01237197     History of Changes
Other Study ID Numbers: 1009M88952
First Submitted: November 1, 2010
First Posted: November 9, 2010
Results First Submitted: September 10, 2013
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014