parallel randomized trial

NCT00877890

A Randomized, Open-Label, Parallel-Group, Comparator-Controlled, Multicenter Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT00877890S001308

Design

Randomized: 254
Start year: 2009
Treatment: 24 weeks
Countries
Sponsor: AstraZeneca (industry)
Eligibility: age 18 or older; HbA1c 7.1 to 11.0 percent; BMI 25 to 45

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly 2 mg	diet and exercise or up to two oral agents; lifestyle: not reported	129	126
A2	Exenatide 10 ug subcutaneous twice daily Exenatide twice daily 10 ug	diet and exercise or up to two oral agents; lifestyle: not reported	125	116

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	mean (years)	56.1	55.2
age	sd (years)	11.14	10.27
female	n	52	55
hba1c	mean (percent)	8.5	8.4
hba1c	sd (percent)	1.10	1.23
other background: MET+SU	n	34	25
other background: MET+TZD	n	13	9
other background: MET	n	51	52
other background: SU+MET+TZD	n	5	1
other background: SU	n	1	8
other background: TZD	n	4	2
other background: diet and exercise	n	21	26
weight	mean (kg)	97.0	94.3
weight	sd (kg)	20.66	18.94

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-1.57 percent	0.104		126	not stated; modified itt; registry:outcomes
24	A1 vs A2	md	-0.67 percent		-0.94 to -0.39		not stated; modified itt; registry:outcomes
24	A2	change	-0.90 percent	0.110		116	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-2.33 kg	0.369		128	not stated; modified itt; registry:outcomes
24	A1 vs A2	md	-0.95 kg		-1.91 to 0.01		not stated; modified itt; registry:outcomes
24	A2	change	-1.37 kg	0.386		120	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
24	A1	responders	58.1			129	not stated; modified itt; registry:outcomes
24	A2	responders	30.1			123	not stated; modified itt; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 129	not stated; modified itt; registry:outcomes
	A2	events				0 / 123	not stated; modified itt; registry:outcomes

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-2.9 mmHg	1.13		128	not stated; modified itt; registry:outcomes
24	A1 vs A2	md	-1.8 mmHg		-4.7 to 1.2		not stated; modified itt; registry:outcomes
24	A2	change	-1.2 mmHg	1.19		120	not stated; modified itt; registry:outcomes

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 129	not stated; modified itt; registry:adverse_events
	A2	events				5 / 123	not stated; modified itt; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 129	not stated; randomized; registry:flow
	A2	events				6 / 125	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				18 / 129	not stated; modified itt; registry:adverse_events
	A2	events				43 / 123	not stated; modified itt; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 129	not stated; modified itt; registry:adverse_events
	A2	events				11 / 123	not stated; modified itt; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 129	not stated; modified itt; registry:adverse_events
	A2	events				5 / 123	not stated; modified itt; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 129	not stated; modified itt; cholecystitis; registry:adverse_events
A1	events	0 / 129	not stated; modified itt; cholelithiasis; registry:adverse_events
A2	events	1 / 123	not stated; modified itt; cholecystitis; registry:adverse_events
A2	events	1 / 123	not stated; modified itt; cholelithiasis; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 129	not stated; modified itt; pancreatitis; registry:adverse_events
	A2	events				0 / 123	not stated; modified itt; pancreatitis; registry:adverse_events