parallel randomized trial

TAO

Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue

Design

Randomized: 45
Start year: 2013
Treatment: 13.04 weeks, follow-up 16 weeks
Countries: Denmark
Sponsor: Bjorn H. Ebdrup (non industry)
Eligibility: age 18 to 65; BMI 30 or more; antipsychotic treated schizophrenia spectrum; no diabetes

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly	antipsychotic treatment; lifestyle: none	23	20	20
A2	Placebo Placebo	antipsychotic treatment; lifestyle: none	22	20	20

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	37.1	34.5
age	sd (years)	10.6	10.1
antipsychotic: atypical monotherapy	n	15	11
antipsychotic: atypical monotherapy	percent	65	50
antipsychotic: polypharmacy	n	7	10
antipsychotic: polypharmacy	percent	30	45
antipsychotic: typical monotherapy	n	1	1
antipsychotic: typical monotherapy	percent	4	5
asian	n	2	3
asian	percent	9	14
bmi	mean (kg/m2)	39.2	38.4
bmi	sd (kg/m2)	3.8	6.1
female	n	12	12
female	percent	52	55
hba1c	mean (mmol/mol)	33.3	34.7
hba1c	sd (mmol/mol)	3.3	4.8
waist	mean (cm)	128.4	125.3
waist	sd (cm)	11.1	13.5
weight	mean (kg)	117.1	110.6
weight	sd (kg)	16.7	17.7
white	n	21	19
white	percent	91	86

9 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 23	not stated; randomized; R0010996:Results
	A2	events				4 / 22	not stated; randomized; R0010996:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 23	not stated; randomized; intolerable gastrointestinal side effects; R0010996:Results
	A2	events				1 / 22	not stated; randomized; severe nausea and dizziness; R0010996:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 22	not stated; randomized; R0010996:Table 4

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 23	not stated; randomized; R0010996:Results
	A2	events				1 / 22	not stated; randomized; severe nausea and dizziness; R0010996:Results

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 23	not stated; randomized; suicide attempt; R0010996:Results
	A2	events				0 / 22	not stated; randomized; suicide attempt; R0010996:Results