parallel randomized trial

NCT00935532

Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)

Type 2 diabetes (adults)NCT00935532S000632

Design

Randomized: 427
Start year: 2009
Treatment: 26 weeks
Countries: Japan
Sponsor: AstraZeneca (industry)
Eligibility: type 2 diabetes on biguanide with or without thiazolidinedione

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide once weekly	biguanide with or without thiazolidinedione; lifestyle: not reported	215	214
A2	Insulin glargine Insulin glargine	biguanide with or without thiazolidinedione; lifestyle: not reported	212	212

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	Insulin glargine A2	Whole trial ALL
age: 65 or older	n	55	56
age	mean (years)	57.1	56.4	56.8
age	sd (years)	10.44	11.16	10.80
egfr: 30 to less than 60	n	107	94
egfr: 60 to less than 90	n	104	116
female	n	73	64	137
hba1c	mean (percent)	8.51	8.50	8.50
hba1c	sd (percent)	0.823	0.791	0.806
other background oad: biguanide tzd	n	70	70
other background oad: biguanide	n	145	142
weight	mean (kg)	69.95	71.03	70.49
weight	sd (kg)	13.246	13.932	13.586

Analyses this trial contributes to

Results

30 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
26	A1	change	-1.11 percent	0.06		214	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-0.43 percent		-0.59 to -0.26		not stated; full analysis; registry:outcomes
26	A2	change	-0.68 percent	0.06		212	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.67 kg	0.17		214	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-2.01 kg		-2.46 to -1.56		not stated; full analysis; registry:outcomes
26	A2	change	0.34 kg	0.17		212	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	responders	42.2			211	not stated; full analysis; registry:outcomes
26	A2	responders	21.0			210	not stated; full analysis; registry:outcomes

Level 2 or 3 hypoglycemia (episode rate) (2 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	rate	0.00				not stated; full analysis; registry:outcomes
	A2	rate	0.00				not stated; full analysis; registry:outcomes

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-4.5 mmHg	14.04		214	not stated; full analysis; registry:outcomes
26	A2	change	-2.6 mmHg	14.29		212	not stated; full analysis; registry:outcomes

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 215	not stated; randomized; registry:flow
	A2	events				0 / 212	not stated; randomized; registry:flow

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 215	not stated; safety; registry:adverse_events
	A2	events				5 / 212	not stated; safety; 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				11 / 215	not stated; randomized; registry:flow
	A2	events				6 / 212	not stated; randomized; registry:flow

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				27 / 215	not stated; safety; registry:adverse_events
	A2	events				6 / 212	not stated; safety; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				18 / 215	not stated; safety; registry:adverse_events
	A2	events				5 / 212	not stated; safety; registry:adverse_events

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				19 / 215	not stated; safety; registry:adverse_events
	A2	events				5 / 212	not stated; safety; registry:adverse_events

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				24 / 215	not stated; safety; registry:adverse_events
	A2	events				7 / 212	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 215	not stated; safety; cholecystitis acute; registry:adverse_events
A1	events	0 / 215	not stated; safety; cholecystitis; registry:adverse_events
A2	events	1 / 212	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 212	not stated; safety; cholecystitis; registry:adverse_events