Trial Outcomes & Findings for The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women (NCT NCT00456885)

NCT ID: NCT00456885

Last Updated: 2017-09-11

Results Overview

Change in weight at the end of each treatment period.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 41 participants
• Primary outcome timeframe: 16 weeks after the beginning of each treatment
• Results posted on: 2017-09-11

Participant Flow

Flyers, Craig's list, posters used for recruitment.Recruitment occurred between 2007 and 2010. After telephone screen subjects were evaluated at the BIDMC clinical research center.

Participant milestones

Measure	Exenatide First, Then Placebo Started on exenatide, 3 week washout, started on placebo.	Placebo First, Then Exenatide Started on placebo, three week washout, started on exenatide.
First Treatment Period, 16 Weeks STARTED	24	17
First Treatment Period, 16 Weeks COMPLETED	24	17
First Treatment Period, 16 Weeks NOT COMPLETED	0	0
Washout, 3 Weeks STARTED	24	17
Washout, 3 Weeks COMPLETED	24	17
Washout, 3 Weeks NOT COMPLETED	0	0
Second Treatment Period, 16 Weeks STARTED	24	17
Second Treatment Period, 16 Weeks COMPLETED	23	17
Second Treatment Period, 16 Weeks NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Exenatide on Weight and Hunger in Obese, Healthy Women

Baseline characteristics by cohort

Measure	All Study Participants n=41 Participants All participants in the study.
Age, Continuous	48 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants
Weight	89 Kilograms STANDARD_DEVIATION 14 • n=5 Participants
BMI	33 Kg/meter^2 STANDARD_DEVIATION 4 • n=5 Participants
HOMA IR	2 Ratio STANDARD_DEVIATION 1 • n=5 Participants
Waist	105 centrimeters STANDARD_DEVIATION 12 • n=5 Participants
Body Fat	40 percent STANDARD_DEVIATION 5 • n=5 Participants
Systolic BP	128 mm of mercury STANDARD_DEVIATION 14 • n=5 Participants
Diastolic BP	75 mm of Mercury STANDARD_DEVIATION 8 • n=5 Participants
HDL	62 mg/dl STANDARD_DEVIATION 19 • n=5 Participants
LDL	114 mg/dl STANDARD_DEVIATION 28 • n=5 Participants
Total Cholesterol	198 mg/dl STANDARD_DEVIATION 32 • n=5 Participants
Triglycerides	111 mg/dl STANDARD_DEVIATION 64 • n=5 Participants
Fasting Insulin	8 mU per liter STANDARD_DEVIATION 6 • n=5 Participants
Fasting Glucose	85 mg/dl STANDARD_DEVIATION 12 • n=5 Participants
Two Hour Glucose	110 mg/dl STANDARD_DEVIATION 32 • n=5 Participants
Adiponectin	6 micrograms/ml STANDARD_DEVIATION 3 • n=5 Participants
Leptin	36 ng/ml STANDARD_DEVIATION 18 • n=5 Participants
Resting Energy Expenditure	1439 Kilocalories STANDARD_DEVIATION 196 • n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks after the beginning of each treatment

Change in weight at the end of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Change in Weight	-2.49 kilograms Standard Error 0.66	0.43 kilograms Standard Error 0.63

PRIMARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Change in Body Mass Index	-0.93 Kg/m^2 Interval -1.44 to -0.41	0.18 Kg/m^2 Interval -0.31 to 0.68

SECONDARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Change in Waist Circumference	-1.68 centimeters Interval -3.3 to -0.07	0.94 centimeters Interval -0.59 to 2.47

SECONDARY outcome

Timeframe: 16 weeks after the beginning of each treatment

Blood pressure was measured using a Dynamap automated monitoring device. The change is reported as the blood pressure measured at the beginning of the treatment group and after 16 weeks. We are reporting the change in the systolic blood presssure recorded.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Systolic Blood Pressure	-2.5 mm of mercury Interval -6.6 to 1.6	-1.3 mm of mercury Interval -5.2 to 2.6

SECONDARY outcome

Timeframe: 16 weeks after the beginning of each treatment

Per cent body body fat was assessed using bio-electrical impedance with a BIA; RJL System Quantum II Bioelectrical Body Composition Analyzer. The data is reported as per cent body fat.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Changes in Body Composition	-0.4 per cent Interval -1.5 to 0.7	-0.7 per cent Interval -1.8 to 0.3

SECONDARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Changes in Leptin	-3.7 ng/ml Interval -7.4 to 0.05	-0.2 ng/ml Interval -3.8 to 3.3

SECONDARY outcome

Timeframe: 16 weeks after the beginning of each treatment

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Diastolic Blood Pressure	-1.2 mm of mercury Interval -3.6 to 1.1	-0.4 mm of mercury Interval -2.6 to 1.9

SECONDARY outcome

Timeframe: 16 weeks after the beginning of each treatment

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Adiponectin	0.4 microgram per ml Interval -0.3 to 1.0	0.07 microgram per ml Interval -0.5 to 0.7

SECONDARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Change in Insulin	1.1 microunits per liter Interval -0.6 to 2.8	0.4 microunits per liter Interval -1.3 to 2.0

SECONDARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Change in Fasting Glucose	0.5 mg/dl Interval -3.6 to 4.5	3.1 mg/dl Interval -0.7 to 7.0

SECONDARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
Change in Two Hour Glucose	-10 mg/dl Interval -21.0 to 1.2	-0.5 mg/dl Interval -11.0 to 10.0

SECONDARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
HOMA Score	0.2 Ratio fasting glucose to insulin Interval -0.3 to 0.6	0.2 Ratio fasting glucose to insulin Interval -0.3 to 0.6

SECONDARY outcome

Timeframe: 16 weeks from the start of each treatment period.

Resting Energy Expenditure

Outcome measures

Measure	Exenatide n=41 Participants All participants that received exenatide.	Placebo n=40 Participants All participants that received placebo.
REE	-13.7 Kilocalories Interval -60.6 to 33.2	6.5 Kilocalories Interval -38.0 to 51.0

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Study Participants n=41 participants at risk
Gastrointestinal disorders Nausea	75.6% 31/41 • 37 weeks Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.
Gastrointestinal disorders Bloating	2.4% 1/41 • Number of events 1 • 37 weeks Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.
Skin and subcutaneous tissue disorders Irritation at injection site	2.4% 1/41 • Number of events 1 • 37 weeks Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.
Gastrointestinal disorders Constipation	4.9% 2/41 • Number of events 2 • 37 weeks Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.
General disorders Fatigue	2.4% 1/41 • Number of events 1 • 37 weeks Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.
Gastrointestinal disorders Heartburn	2.4% 1/41 • Number of events 1 • 37 weeks Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.
Gastrointestinal disorders Diarrhea	2.4% 1/41 • Number of events 1 • 37 weeks Adverse effects were monitored as all participant adverse events and were not monitored by intervention or sequence.

Additional Information

Jody Dushay

BIDMC

Phone: 6177353343

Email: jdushay@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place