parallel randomized trial

S003092

Design

Randomized: 117
Start year: 2009
Treatment: 12 weeks, follow-up 12 weeks
Countries: China
Sponsor: (not reported)
Eligibility: T2DM with ultrasound NAFLD; FBG 6.0 to 10.0 mmol/L or HbA1c 7 to 9 percent

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	lifestyle: standard		49
A2	Metformin Metformin	lifestyle: standard		68

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Metformin A2
age	mean (years)	51.02	54.68
age	sd (years)	10.10	12.14
bmi	mean (kg/m2)	28.18	27.61
bmi	sd (kg/m2)	1.86	1.77
female	n	21	30
hba1c	mean (percent)	8.14	8.09
hba1c	sd (percent)	0.51	0.59
weight	mean (kg)	80.61	78.58
weight	sd (kg)	11.23	10.76

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-0.91 percent	0.65	49	not stated; completers; R0026372:Table 3
12	A1	final	7.15 percent	0.36	49	not stated; completers; R0026372:Table 2
12	A2	change	-0.89 percent	0.57	68	not stated; completers; R0026372:Table 3
12	A2	final	7.16 percent	0.58	68	not stated; completers; R0026372:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12	A1	change	-4.16 kg	5.32	49	not stated; completers; R0026372:Table 3
12	A1	final	76.09 kg	9.85	49	not stated; completers; R0026372:Table 2
12	A2	change	-1.98 kg	3.28	68	not stated; completers; R0026372:Table 3
12	A2	final	77.22 kg	10.15	68	not stated; completers; R0026372:Table 2

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	responders				18 / 49	not stated; completers; R0026372:Table 4
12	A2	responders				28 / 68	not stated; completers; R0026372:Table 4

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				3 / 68	not stated; completers; R0026372:Results