Trial Outcomes & Findings for Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying (NCT NCT02160990)

Results Overview

Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

time frame is 30 days after the initiation of dose.

Results posted on

2016-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Exenatide Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.	Total n=20 Participants Total of all reporting groups
Age, Continuous	34 years n=5 Participants	42.5 years n=7 Participants	39.3 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: time frame is 30 days after the initiation of dose.

Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).

Outcome measures

Outcome measures
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Gastric Emptying Half-time (T 1/2) of Solids	187 minutes Interval 141.0 to 240.0	86 minutes Interval 73.0 to 125.0

SECONDARY outcome

Timeframe: Visit 4, approximately 1 hours after radiolabeled meal was ingested

Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 1 hour.

Outcome measures

Outcome measures
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Percentage of Gastric Contents Emptied at 1 Hour	12.4 percentage of meal emptied Interval 8.0 to 18.5	38.2 percentage of meal emptied Interval 26.6 to 42.1

SECONDARY outcome

Timeframe: baseline, day 30

Outcome measures

Outcome measures
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Change in Body Weight	-0.95 kg Interval -2.1 to -0.7	-0.55 kg Interval -2.1 to 0.3

SECONDARY outcome

Timeframe: Visit 3, approximately 30 minutes after liquid meal

In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.

Outcome measures

Outcome measures
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Satiation Expressed as Volume to Fullness	705 mL Interval 510.0 to 795.0	675 mL Interval 413.0 to 825.0

SECONDARY outcome

Timeframe: Visit 3, approximately 30 minutes after liquid meal

In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 5.

Outcome measures

Outcome measures
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Maximum Tolerated Volume	1244 mL Interval 918.0 to 1452.0	1052 mL Interval 859.1 to 1422.0

SECONDARY outcome

Timeframe: Visit 4, approximately 30 minutes after start of "all you can eat" meal

Five hours after the standard egg meal ingested to measure gastric emptying, subjects were invited to eat, over a 30 minute period, a standard "all you can eat" meal. This meal consisted of either meat or vegetable lasagna, vanilla pudding, and skim milk. Personnel from the study team weighed the food servings post-meal and reported the amount of food left from single portions partially consumed. The total kcal of the food consumed was analyzed by using validated software.

Outcome measures

Outcome measures
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Buffet Meal Intake (kcal)	977 kcal Interval 713.0 to 1336.0	1110 kcal Interval 680.3 to 1658.0

SECONDARY outcome

Timeframe: Visit 3, approximately 30 min after ingestion of nutrient drink test

Postprandial fullness, nausea, bloating, and pain were measured 30 minutes after the liquid meal using 100 mm horizontal visual analog scales (VAS). The subscale scores could each range from "none"(0) to "worst ever" (100) at the left and right ends of the lines for each symptom. These satiation symptom scores (postprandial fullness, nausea, bloating, and pain) were combined to generate a total scale score with a different total scale range (0 - 400 mm) with 0 mm indicating "none" and 400 indicating "worst ever."

Outcome measures

Outcome measures
Measure	Exenatide n=10 Participants Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.	Placebo n=10 Participants Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
Aggregate Satiation Symptom Score	145 mm Interval 133.5 to 204.0	172 mm Interval 110.0 to 237.0

Adverse Events

Exenatide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Camilleri

Mayo Clinic

Phone: 507-284-6218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place