parallel randomized trial

NCT01432405

Effect of Exenatide Treatment on Hepatic Fat Content and Plasma Adipocytokine Levels in Patients With Type 2 Diabetes Mellitus

Design

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Pioglitazone and exenatide	pioglitazone 30 mg 2 weeks then 45 mg daily, started in both arms; diet or metformin; lifestyle: standard	12	11
A2	Standard care or no added treatment Pioglitazone	pioglitazone 30 mg 2 weeks then 45 mg daily, started in both arms; diet or metformin; lifestyle: standard	12	10

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

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Standard care or no added treatment A2	Whole trial ALL
age: 18 or less	n	0	0
age: 18 to 65	n	11	10
age: 65 or older	n	0	0
age	mean (years)	49	55
bmi	mean (kg/m2)			32.0
bmi	se (kg/m2)			1.5
female	n	7	8
hba1c	mean (percent)			8.2
hba1c	se (percent)			0.4

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

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52.14	A1	change	0.2 kg			11	not stated; completers; R0022834:Results
52.14	A2	change	3.7 kg			10	not stated; completers; R0022834:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; registry:adverse_events
	A2	events				0 / 12	not stated; safety; registry:adverse_events

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 11	not stated; completers; R0022834:Abstract