parallel randomized trial

NCT01107717

Durability of Early Initial Combination Therapy With Exenatide/Pioglitazone/Metformin vs Conventional Therapy in New Onset Type 2 Diabetes

Design

Randomized: 318
Start year: 2009
Treatment: 156.54 weeks, follow-up 313.08 weeks
Countries: United States (1 sites)
Sponsor: The University of Texas Health Science Center at San Antonio (mixed)
Eligibility: newly diagnosed drug naive T2D without cardiovascular or renal complications

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	exenatide plus pioglitazone Triple therapy: metformin, pioglitazone, exenatide	metformin 1000 mg; basal insulin rescue if HbA1c above 6.5 percent; lifestyle: not reported	157	103
A2	Sequential metformin sulfonylurea insulin Conventional sequential therapy	lifestyle: not reported	161	114

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

Characteristic	Statistic	Triple therapy: metformin, pioglitazone, exenatide A1	Sequential metformin sulfonylurea insulin A2
age	mean (years)	44	47
age	sd (years)	1	1
bmi	mean (kg/m2)	36.4	36.1
bmi	sd (kg/m2)	1.1	1.1
diabetes duration	mean (months)	4.8	5.2
diabetes duration	sd (months)	0.5	0.5
female	n	52	72
hba1c	mean (percent)	9.0	8.8
hba1c	sd (percent)	0.2	0.2
other mexican american	n	73	75
white	n	15	15

16 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
156.54	A1	final	6.9 percent	0.1	103	not stated; completers; registry:outcomes
156.54	A2	final	6.4 percent	0.1	114	not stated; completers; registry:outcomes
313.08	A1	final	5.7 percent	0.1	29	not stated; other; R0017285:Table 1
313.08	A2	final	6.0 percent	0.1	26	not stated; other; R0017285:Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
313.08	A1	final	98.7 kg	4.4		29	not stated; other; R0017285:Table 1
313.08	A2	final	95.7 kg	4.2		26	not stated; other; R0017285:Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				14 / 103	not stated; completers; registry:outcomes
	A2	events				52 / 114	not stated; completers; registry:outcomes

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
313.08	A1	final	126 mmHg	3		29	not stated; other; R0017285:Table 1
313.08	A2	final	124 mmHg	3		26	not stated; other; R0017285:Table 1

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 103	not stated; completers; registry:adverse_events
	A2	events				2 / 114	not stated; completers; registry:adverse_events

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 103	not stated; completers; registry:adverse_events
	A2	events				0 / 114	not stated; completers; registry:adverse_events

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				26 / 103	not stated; completers; registry:adverse_events
	A2	events				0 / 114	not stated; completers; registry:adverse_events