parallel randomized trial

S003010

Design

Randomized: 56
Start year: 2017
Treatment: 24 weeks, follow-up 30 weeks
Countries: Spain (1 sites)
Sponsor: Arnau de Vilanova University Hospital (industry)
Eligibility: age 18 to 60; BMI 35.0 to 42.5 awaiting bariatric surgery; HbA1c 7.0 to 10.0; eGFR 60 or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide extended release plus dapagliflozin Exenatide once weekly plus dapagliflozin with diet	usual glucose lowering therapy except SGLT2i and GLP-1 RA; 500 kcal deficit low fat diet; lifestyle: standard	26	24	24
A2	Standard care or no added treatment Low fat hypocaloric diet (control)	usual glucose lowering therapy except SGLT2i and GLP-1 RA; 500 kcal deficit low fat diet; lifestyle: standard	30	25	25

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

Characteristic	Statistic	Exenatide once weekly plus dapagliflozin with diet A1	Standard care or no added treatment A2
age	mean (years)	49.1	51.5
age	sd (years)	8.2	6.7
bmi	mean (kg/m2)	38.4	38.4
bmi	sd (kg/m2)	2.4	2.6
established cvd	n	3	2
established cvd	percent	11.5	6.6
female	n	8	12
female	percent	32.0	41.3
hba1c	mean (percent)	8.4	8.2
hba1c	sd (percent)	0.7	0.8
metformin use	percent	91.6	92.0
other basal insulin use	percent	33.3	32.0
other dpp4i use	percent	50.0	44.0
other sulfonylurea use	percent	25.0	20.0
other tzd use	percent	0.0	8.0
sbp	mean (mmHg)	143.6	142.1
sbp	sd (mmHg)	18.6	16.8
waist	mean (cm)	122.3	123.2
waist	sd (cm)	8.2	9.1
weight	mean (kg)	108.2	108.4
weight	sd (kg)	13.1	14.8
white	n	23	27
white	percent	92.0	93.1

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.6 percent		-2.0 to -1.3	24	not stated; per protocol; R0010440:Table 2
24	A1	final	6.6 percent	0.8		24	not stated; per protocol; R0010440:Table 2
24	A1 vs A2	md	-0.1 percent		-0.7 to 0.4		not stated; per protocol; R0010440:Table 2
24	A2	change	-1.5 percent		-1.9 to -1.0	25	not stated; per protocol; R0010440:Table 2
24	A2	final	6.7 percent	0.7		25	not stated; per protocol; R0010440:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-6.6 kg		-8.5 to -4.6	24	not stated; per protocol; R0010440:Table 2
24	A1	final	101.6 kg	15.5		24	not stated; per protocol; R0010440:Table 2
24	A1 vs A2	md	-8.1 kg		-11.0 to -5.2		not stated; per protocol; R0010440:Table 2
24	A2	change	1.5 kg		-0.6 to 3.7	25	not stated; per protocol; R0010440:Table 2
24	A2	final	110.0 kg	17.0		25	not stated; per protocol; R0010440:Table 2

Level 2 or 3 hypoglycemia (participants) (2 lines; O04)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; R0010440:Results
	A2	events				0 / 29	not stated; safety; R0010440:Results

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate				25	not stated; safety; R0010440:Results
	A2	rate				29	not stated; safety; R0010440:Results

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	change	-13.2 mmHg	-20.3 to -6.1	24	not stated; per protocol; R0010440:Table 2
24	A1 vs A2	md	-6.0 mmHg	-16.8 to 4.7		not stated; per protocol; R0010440:Table 2
24	A2	change	-7.2 mmHg	-15.6 to 1.2	25	not stated; per protocol; R0010440:Table 2

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	58.3			24	not stated; per protocol; R0010440:Results
24	A2	responders	16.0			25	not stated; per protocol; R0010440:Results

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	20.8			24	not stated; per protocol; R0010440:Results
24	A2	responders	0			25	not stated; per protocol; R0010440:Results

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 29	not stated; safety; R0010440:Results

Health related quality of life total score (any instrument) (3 lines; O24C)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	change	-5.1 points	-13.8 to 3.5	24	not stated; per protocol; R0010440:Table 2
24	A1 vs A2	md	-2.5 points			not stated; per protocol; R0010440:Table 2
24	A2	change	-2.6 points	-8.0 to 2.6	25	not stated; per protocol; R0010440:Table 2

Serious adverse events (1 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 29	not stated; safety; R0010440:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; R0010440:Results
	A2	events				0 / 29	not stated; safety; R0010440:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 25	not stated; safety; R0010440:Results
	A2	events				0 / 29	not stated; safety; R0010440:Results