parallel randomized trial

NCT00082407

Efficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

Type 2 diabetes (adults)NCT00082407S000441

Design

Randomized: 505
Start year: 2003
Treatment: 52 weeks, follow-up 52 weeks
Countries: multinational
Sponsor: Eli Lilly and Amylin Pharmaceuticals (registry lists AstraZeneca) (industry)
Eligibility: Age 30 to 75; HbA1c 7.0 to 11.0 on metformin plus sulfonylurea; BMI 25 to 40

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: MMRM, no imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	metformin and sulfonylurea; lifestyle: not reported	255	253
A2	Premixed insulin Biphasic insulin aspart 30 twice daily	metformin and sulfonylurea; lifestyle: not reported	250	248

Baseline characteristics

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)	59	58
age	sd (years)	9	9
bmi	mean (kg/m2)	30.6	30.2
bmi	sd (kg/m2)	4.0	4.2
diabetes duration	mean (years)	9.8	10.0
diabetes duration	sd (years)	6.3	6.2
female	n	135	122
female	percent	47	51
hba1c	mean (percent)	8.6	8.6
hba1c	sd (percent)	1.0	1.1
sbp	mean (mmHg)	138	136
sbp	sd (mmHg)	16	15
weight	mean (kg)	85.5	83.4
weight	sd (kg)	15.7	15.6

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	-1.04 percent	0.07		253	not stated; modified itt; R0025791:Table 2
52	A1	change	-0.98 percent	0.07		248	not stated; modified itt; registry:outcomes
52	A1 vs A2	md	-0.15 percent		-0.32 to 0.01		not stated; modified itt; R0025791:Table 2
52	A1 vs A2	md	-0.10 percent		-0.28 to 0.08		not stated; modified itt; registry:outcomes
52	A1 vs A2	md	-0.15 percent		-0.32 to 0.01		not stated; per protocol; R0025791:Table 2
52	A2	change	-0.89 percent	0.06		248	not stated; modified itt; R0025791:Table 2
52	A2	change	-0.88 percent	0.07		246	not stated; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	-2.54 kg	0.17		205	not stated; modified itt; registry:outcomes
52	A1	change	-2.5 kg	0.2		253	not stated; modified itt; R0025791:Table 2
52	A1 vs A2	md	-5.4 kg		-5.9 to -5.0		not stated; modified itt; R0025791:Table 2
52	A2	change	2.9 kg	0.2		248	not stated; modified itt; R0025791:Table 2
52	A2	change	2.92 kg	0.17		223	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	responders				72 / 227	not stated; modified itt; R0025791:p5
52	A2	responders				57 / 237	not stated; modified itt; R0025791:p5

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		0 / 253	not stated; modified itt; R0025791:p6
A1	events	53.0	253	not stated; modified itt; registry:outcomes
A2	events	51.6	248	not stated; modified itt; registry:outcomes
A2	events		0 / 248	not stated; modified itt; R0025791:p6

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
52	A1	change	-5 mmHg	15			not stated; other; R0025791:p6
52	A2	change	1 mmHg	16			not stated; other; R0025791:p6

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 253	not stated; modified itt; R0025791:Table 3
	A2	events				1 / 248	not stated; modified itt; R0025791:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				19 / 253	not stated; modified itt; R0025791:Table 3
	A2	events				11 / 248	not stated; modified itt; R0025791:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				20 / 253	not stated; modified itt; R0025791:p4
	A2	events				0 / 248	not stated; modified itt; R0025791:p4

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				84 / 253	not stated; modified itt; R0025791:Table 3
	A2	events				1 / 248	not stated; modified itt; R0025791:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				38 / 253	not stated; modified itt; R0025791:Table 3
	A2	events				8 / 248	not stated; modified itt; R0025791:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				24 / 253	not stated; modified itt; R0025791:Table 3
	A2	events				5 / 248	not stated; modified itt; R0025791:Table 3

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	5.1			253	not stated; modified itt; R0025791:p6

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 253	not stated; modified itt; R0025791:Table 3
	A2	events				1 / 248	not stated; modified itt; R0025791:Table 3