parallel randomized trial

S003044

Design

Randomized: 95
Start year: 2015
Treatment: 24 weeks, follow-up 24 weeks
Countries: China (1 sites)
Sponsor: (mixed)
Eligibility: HbA1c 7.0 to <10.0%; BMI 18.5 to <25; waist >85 cm men, >80 cm women; stable oral agents

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide	oral antidiabetes drugs; lifestyle: standard	49	40
A2	Premixed insulin Humalog Mix25	oral antidiabetes drugs; lifestyle: standard	46	41

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Premixed insulin A2
age	mean (years)	56.10	60.37
age	sd (years)	11.14	10.83
bmi	mean (kg/m2)	23.96	23.50
bmi	sd (kg/m2)	1.18	1.24
diabetes duration	median (years)	8.00	11.00
diabetes duration	q1 (years)	4.50	7.00
diabetes duration	q3 (years)	14.50	14.00
female	n	18	23
female	percent	36.73	50.00
hba1c	mean (percent)	8.53	8.47
hba1c	sd (percent)	1.07	0.92
metformin use	n	27	17
metformin use	percent	55.10	36.96
other alpha glucosidase inhibitor use	n	7	10
other alpha glucosidase inhibitor use	percent	14.29	21.74
other glinide use	n	4	4
other glinide use	percent	8.16	8.69
other sulfonylurea use	n	18	17
other sulfonylurea use	percent	36.73	36.95
sbp	mean (mmHg)	126.00	132.54
sbp	sd (mmHg)	14.50	14.59
waist	mean (cm)	88.82	88.37
waist	sd (cm)	5.49	3.97
weight	mean (kg)	67.65	63.87
weight	sd (kg)	9.20	6.20

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

HbA1c change (2 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	7.05 percent	1.04		40	not stated; completers; R0023353:Table 2
24	A2	final	7.42 percent	0.83		41	not stated; completers; R0023353:Table 2

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-3.55 kg		40	not stated; completers; R0023353:Results
24	A1	final	64.53 kg	10.41	40	not stated; completers; R0023353:Table 2
24	A2	change	-1.66 kg		41	not stated; completers; R0023353:Results
24	A2	final	62.24 kg	7.04	41	not stated; completers; R0023353:Table 2

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	mmHg			40	not stated; completers; R0023353:Table 2
24	A2	final	128.7 mmHg	10.6		41	not stated; completers; R0023353:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 49	not stated; randomized; R0023353:Results
	A2	events				1 / 46	not stated; randomized; R0023353:Results

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 49	not stated; randomized; gastrointestinal bleeding; R0023353:Results
A1	events	1 / 49	not stated; randomized; gastrointestinal side effects; R0023353:Results
A2	events	1 / 46	not stated; randomized; broken right leg; R0023353:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 49	not stated; randomized; gastrointestinal bleeding; R0023353:Results
	A1	events				1 / 49	not stated; randomized; gastrointestinal side effects; R0023353:Results