Trial Outcomes & Findings for The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects (NCT NCT00856609)
NCT ID: NCT00856609
Last Updated: 2019-06-04
Results Overview
Mean of 3-day food intake change between 3 days (Day 6-7-8) at baseline assessment and 3 days (Day 12-13-14) during the intervention period between the exenatide and placebo groups
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)
Results posted on
2019-06-04
Participant Flow
Out of 150 planned total number of enrollment, 145 participants were recruited. Among the 145 participants, 84 participants met inclusion criteria. Only 80 participants out of 84 were randomized.
Participant milestones
| Measure |
Exenatide
10 micrograms subcutaneously twice
Byetta (exenatide): Exenatide is an injectable medication
Weight loss: Because response to weight loss
|
Placebo
Twice daily
Metabolic Chamber: The subject stays in the small room
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
39
|
|
Overall Study
COMPLETED
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Exenatide
10 micrograms subcutaneously twice
Byetta (exenatide): Exenatide is an injectable medication
Weight loss: Because response to weight loss
|
Placebo
Twice daily
Metabolic Chamber: The subject stays in the small room
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
The Effects of Exenatide (Byetta ) on Energy Expenditure and Weight Loss in Nondiabetic Obese Subjects
Baseline characteristics by cohort
| Measure |
Exenatide
n=40 Participants
10 micrograms subcutaneously twice
Byetta (exenatide): Exenatide is an injectable medication
Weight loss: Because response to weight loss
|
Placebo
n=39 Participants
Twice daily
Metabolic Chamber: The subject stays in the small room
Placebo
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
33.7 years
STANDARD_DEVIATION 9.0 • n=107 Participants
|
34.4 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Body weight
|
105.5 kg
STANDARD_DEVIATION 19.2 • n=99 Participants
|
108.8 kg
STANDARD_DEVIATION 20.7 • n=107 Participants
|
107.1 kg
STANDARD_DEVIATION 19.9 • n=206 Participants
|
|
Body Mass Index
|
38.0 kg/m^2
STANDARD_DEVIATION 6.6 • n=99 Participants
|
38.2 kg/m^2
STANDARD_DEVIATION 6.8 • n=107 Participants
|
38.1 kg/m^2
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
Fat free mass
|
34.6 Kg
STANDARD_DEVIATION 11.5 • n=99 Participants
|
37.9 Kg
STANDARD_DEVIATION 8.7 • n=107 Participants
|
36.3 Kg
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Fat mass
|
27.9 Kg
STANDARD_DEVIATION 8.8 • n=99 Participants
|
30.8 Kg
STANDARD_DEVIATION 8.7 • n=107 Participants
|
29.4 Kg
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Body fat
|
44.0 percent
STANDARD_DEVIATION 6.9 • n=99 Participants
|
44.4 percent
STANDARD_DEVIATION 8.7 • n=107 Participants
|
44.2 percent
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Fasting glucose
|
96.9 mg/dl
STANDARD_DEVIATION 8.5 • n=99 Participants
|
98.8 mg/dl
STANDARD_DEVIATION 8.8 • n=107 Participants
|
97.8 mg/dl
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Two-hour glucose
|
139.4 mg/dl
STANDARD_DEVIATION 25.7 • n=99 Participants
|
135.1 mg/dl
STANDARD_DEVIATION 25.6 • n=107 Participants
|
137.2 mg/dl
STANDARD_DEVIATION 25.6 • n=206 Participants
|
|
Mean energy intake
|
3495.5 kcal/day
STANDARD_DEVIATION 1169.6 • n=99 Participants
|
3093.5 kcal/day
STANDARD_DEVIATION 992.3 • n=107 Participants
|
3294.5 kcal/day
STANDARD_DEVIATION 1096.3 • n=206 Participants
|
|
Percentage of calories needed for weight maintenance participants consumed
|
119.3 Percentage of Carlories
STANDARD_DEVIATION 42.1 • n=99 Participants
|
105.4 Percentage of Carlories
STANDARD_DEVIATION 29.6 • n=107 Participants
|
112.3 Percentage of Carlories
STANDARD_DEVIATION 36.9 • n=206 Participants
|
|
Carbohydrates intake
|
1785.5 kcal/day
STANDARD_DEVIATION 595.5 • n=99 Participants
|
1593.8 kcal/day
STANDARD_DEVIATION 476.1 • n=107 Participants
|
1689.7 kcal/day
STANDARD_DEVIATION 544.0 • n=206 Participants
|
|
Fat intake
|
1305.3 kcal/day
STANDARD_DEVIATION 488.4 • n=99 Participants
|
1130.9 kcal/day
STANDARD_DEVIATION 484.6 • n=107 Participants
|
1218.1 kcal/day
STANDARD_DEVIATION 491.2 • n=206 Participants
|
|
Protein intake
|
434.2 kcal/day
STANDARD_DEVIATION 159.5 • n=99 Participants
|
396.9 kcal/day
STANDARD_DEVIATION 139.6 • n=107 Participants
|
415.6 kcal/day
STANDARD_DEVIATION 150.1 • n=206 Participants
|
|
Soda intake
|
206.5 kcal/day
STANDARD_DEVIATION 191.3 • n=99 Participants
|
183.3 kcal/day
STANDARD_DEVIATION 169.1 • n=107 Participants
|
195.0 kcal/day
STANDARD_DEVIATION 159.5 • n=206 Participants
|
|
24 hour energy expenditure
|
2319.3 kcal/day
STANDARD_DEVIATION 377.0 • n=99 Participants
|
2333.8 kcal/day
STANDARD_DEVIATION 422.0 • n=107 Participants
|
2325.9 kcal/day
STANDARD_DEVIATION 385.3 • n=206 Participants
|
|
Respiratory quotient
|
0.86 ratio
STANDARD_DEVIATION 0.03 • n=99 Participants
|
0.85 ratio
STANDARD_DEVIATION 0.03 • n=107 Participants
|
0.86 ratio
STANDARD_DEVIATION 0.03 • n=206 Participants
|
|
Carbohydrate oxidation
|
1121.1 kcal/day
STANDARD_DEVIATION 353.5 • n=99 Participants
|
1068.4 kcal/day
STANDARD_DEVIATION 322.5 • n=107 Participants
|
1097.0 kcal/day
STANDARD_DEVIATION 338.3 • n=206 Participants
|
|
Lipid Oxidation
|
781.0 kcal/day
STANDARD_DEVIATION 330.2 • n=99 Participants
|
873.5 kcal/day
STANDARD_DEVIATION 377.6 • n=107 Participants
|
823.3 kcal/day
STANDARD_DEVIATION 353.1 • n=206 Participants
|
|
Sleeping metabolic rate
|
1818.1 kcal/day
STANDARD_DEVIATION 277.5 • n=99 Participants
|
1800.6 kcal/day
STANDARD_DEVIATION 286.5 • n=107 Participants
|
1810.1 kcal/day
STANDARD_DEVIATION 279.7 • n=206 Participants
|
|
Awake fed thermogenesis
|
629.9 kcal/day
STANDARD_DEVIATION 176.3 • n=99 Participants
|
671.0 kcal/day
STANDARD_DEVIATION 232.0 • n=107 Participants
|
648.7 kcal/day
STANDARD_DEVIATION 203.2 • n=206 Participants
|
|
Spontaneous physical activity
|
80.4 kcal/day
STANDARD_DEVIATION 47.1 • n=99 Participants
|
79.4 kcal/day
STANDARD_DEVIATION 43.4 • n=107 Participants
|
80.0 kcal/day
STANDARD_DEVIATION 45.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: Day 6-7-8 (at baseline) and Day 12-13-14 (3 days after starting study intervention)Mean of 3-day food intake change between 3 days (Day 6-7-8) at baseline assessment and 3 days (Day 12-13-14) during the intervention period between the exenatide and placebo groups
Outcome measures
| Measure |
Exenatide
n=39 Participants
10 micrograms subcutaneously twice
Byetta (exenatide): Exenatide is an injectable medication
Weight loss: Because response to weight loss
|
Placebo
n=39 Participants
Twice daily
Metabolic Chamber: The subject stays in the small room
Placebo
|
|---|---|---|
|
Energy Intake
|
1016.1 kcal/day
Standard Deviation 724.5
|
245.1 kcal/day
Standard Deviation 710.5
|
PRIMARY outcome
Timeframe: Day 5 and Day 11Change of twenty-four-hour energy expenditure between at Day 5 at baseline assessment and at Day 11 two days after starting study medication between the exenatide and placebo groups
Outcome measures
| Measure |
Exenatide
n=38 Participants
10 micrograms subcutaneously twice
Byetta (exenatide): Exenatide is an injectable medication
Weight loss: Because response to weight loss
|
Placebo
n=33 Participants
Twice daily
Metabolic Chamber: The subject stays in the small room
Placebo
|
|---|---|---|
|
Twenty-four-hour Energy Expenditure
|
51.6 kcal/day
Standard Deviation 157.2
|
28.9 kcal/day
Standard Deviation 119.7
|
SECONDARY outcome
Timeframe: 5 weeksMean decrease between pre- and post-randomization in 5 Weeks between the exenatide and placebo groups.
Outcome measures
| Measure |
Exenatide
n=31 Participants
10 micrograms subcutaneously twice
Byetta (exenatide): Exenatide is an injectable medication
Weight loss: Because response to weight loss
|
Placebo
n=33 Participants
Twice daily
Metabolic Chamber: The subject stays in the small room
Placebo
|
|---|---|---|
|
Body Weight
|
1.6 kg
Standard Deviation 3.15
|
0.27 kg
Standard Deviation 2.96
|
Adverse Events
Exenatide
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exenatide
n=40 participants at risk
10 micrograms subcutaneously twice
Byetta (exenatide): Exenatide is an injectable medication
Weight loss: Because response to weight loss
|
Placebo
n=39 participants at risk
Twice daily
Metabolic Chamber: The subject stays in the small room
Placebo
|
|---|---|---|
|
Endocrine disorders
hypoglycemia
|
25.0%
10/40
|
7.7%
3/39
|
|
Skin and subcutaneous tissue disorders
Itchiness
|
30.0%
12/40
|
10.3%
4/39
|
|
Metabolism and nutrition disorders
hunger decrease
|
97.5%
39/40
|
10.3%
4/39
|
|
Product Issues
Injection site reaction
|
32.5%
13/40
|
12.8%
5/39
|
|
Gastrointestinal disorders
Nausea
|
60.0%
24/40
|
48.7%
19/39
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
16/40
|
41.0%
16/39
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
32.5%
13/40
|
38.5%
15/39
|
|
General disorders
Headache
|
57.5%
23/40
|
53.8%
21/39
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
11/40
|
20.5%
8/39
|
|
Gastrointestinal disorders
Constipation
|
35.0%
14/40
|
23.1%
9/39
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
15.0%
6/40
|
2.6%
1/39
|
|
General disorders
Palpitations
|
10.0%
4/40
|
12.8%
5/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place