parallel randomized trial

NCT00917267

A Comparator-Controlled Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control (HbA1c) and Safety in Asian Subjects With Type 2 Diabetes Mellitus Managed With Oral Antidiabetic Medications

Type 2 diabetes (adults)NCT00917267S001437

Design

Randomized: 681
Start year: 2009
Treatment: 26 weeks, follow-up 36 weeks
Countries: China, India, Japan, South Korea, Taiwan (49 sites)
Sponsor: AstraZeneca (industry)
Eligibility: Asian adults 20 or older; HbA1c 7 to 11; BMI 21 to 35; on oral drugs

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly 2 mg	stable oral agents; sulfonylurea at minimum dose; lifestyle: not reported		340
A2	Exenatide 10 ug subcutaneous twice daily Exenatide twice daily 10 ug	stable oral agents; sulfonylurea at minimum dose; lifestyle: not reported		338

Baseline characteristics

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

Characteristic	Statistic	Exenatide extended release 2 mg subcutaneous once weekly A1	Exenatide 10 ug subcutaneous twice daily A2
age: 18 to 65	n	275	274
age: 65 or older	n	65	64
age	mean (years)	55.4	56.2
age	sd (years)	10.59	9.99
bmi	mean (kg/m2)	26.4	26.7
female	n	157	154
hba1c	mean (percent)	8.7	8.7
hba1c	sd (percent)	1.04	1.03
other background: MET+SU+TZD	n	6	10
other background: MET+SU	n	210	216
other background: MET+TZD	n	12	9
other background: MET	n	62	60
other background: SU+TZD	n	18	12
other background: SU	n	30	29
other background: TZD	n	2	2
other sulfonylurea use	percent	77.6	79.0
sbp	mean (mmHg)	131.09	131.59
sbp	se (mmHg)	0.84	0.84
weight	mean (kg)	69.6	70.4
weight	sd (kg)	12.44	12.09

Analyses this trial contributes to

Results

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

HbA1c change (5 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.43 percent	0.07		307	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-0.31 percent		-0.49 to -0.14		not stated; modified itt; R0026895:Results
26	A1 vs A2	md	-0.31 percent		-0.51 to -0.11		not stated; modified itt; hba1c:<9; R0026895:Results
26	A1 vs A2	md	-0.29 percent		-0.54 to -0.03		not stated; modified itt; hba1c:>=9; R0026895:Results
26	A2	change	-1.12 percent	0.07		263	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (7 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	0.82 kg		0.39 to 1.25		not stated; modified itt; registry:outcomes
26	A1	change	-1.63 kg	0.16		309	not stated; modified itt; registry:outcomes
26	A1	change	-1.26 kg				not stated; modified itt; bmi:<25; R0026895:Results
26	A1	change	-1.75 kg				not stated; modified itt; bmi:>=25; R0026895:Results
26	A2	change	-1.95 kg				not stated; modified itt; bmi:<25; R0026895:Results
26	A2	change	-2.45 kg	0.16		265	not stated; modified itt; registry:outcomes
26	A2	change	-2.33 kg				not stated; modified itt; bmi:>=25; R0026895:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	46.7			332	not stated; modified itt; registry:outcomes
26	A2	responders	35.7			333	not stated; modified itt; registry:outcomes

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
26	A1	change	-5.41 mmHg	0.82	340	not stated; modified itt; R0026895:Table 1
26	A1	change	-5.33 mmHg	15.99	337	not stated; modified itt; registry:outcomes
26	A2	change	-5.38 mmHg	0.86	338	not stated; modified itt; R0026895:Table 1
26	A2	change	-5.22 mmHg	16.23	335	not stated; modified itt; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 340	not stated; modified itt; R0026895:Results
	A2	events				0 / 338	not stated; modified itt; R0026895:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	13 / 340	not stated; modified itt; R0026895:Table 2
A1	events	13 / 340	not stated; modified itt; registry:adverse_events
A2	events	9 / 338	not stated; modified itt; R0026895:Table 2
A2	events	8 / 338	not stated; modified itt; registry:adverse_events

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		15 / 346	not stated; randomized; registry:flow
A1	events	4.4	340	not stated; modified itt; R0026895:Results
A2	events		36 / 345	not stated; randomized; registry:flow
A2	events	10.4	338	not stated; modified itt; R0026895:Results

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	37 / 340	not stated; modified itt; R0026895:Table 2
A1	events	32 / 340	not stated; modified itt; registry:adverse_events
A2	events	89 / 338	not stated; modified itt; R0026895:Table 2
A2	events	73 / 338	not stated; modified itt; registry:adverse_events

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	28 / 340	not stated; modified itt; R0026895:Table 2
A1	events	27 / 340	not stated; modified itt; registry:adverse_events
A2	events	39 / 338	not stated; modified itt; registry:adverse_events
A2	events	41 / 338	not stated; modified itt; R0026895:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	32 / 340	not stated; modified itt; registry:adverse_events
A1	events	33 / 340	not stated; modified itt; R0026895:Table 2
A2	events	27 / 338	not stated; modified itt; registry:adverse_events
A2	events	28 / 338	not stated; modified itt; R0026895:Table 2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				20 / 340	not stated; modified itt; R0026895:Table 2
	A2	events				24 / 338	not stated; modified itt; R0026895:Table 2

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	0 / 340	not stated; modified itt; nausea; R0026895:Results
A1	events	1 / 340	not stated; modified itt; vomiting; R0026895:Results
A2	events	12 / 338	not stated; modified itt; nausea; R0026895:Results
A2	events	6 / 338	not stated; modified itt; vomiting; R0026895:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 340	not stated; modified itt; registry:adverse_events
	A2	events				0 / 338	not stated; modified itt; registry:adverse_events

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 340	not stated; modified itt; vitreous haemorrhage; registry:adverse_events
	A2	events				1 / 338	not stated; modified itt; vitreous haemorrhage; registry:adverse_events

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 340	not stated; modified itt; ileus; registry:adverse_events
	A2	events				1 / 338	not stated; modified itt; ileus; registry:adverse_events