parallel randomized trial

NCT00641056

Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea

Type 2 diabetes (adults)NCT00641056S001768

Design

Randomized: 467
Start year: 2008
Treatment: 84 weeks, follow-up 84 weeks
Countries
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 or older; HbA1c 7.1 to 11.0 percent; BMI 25 to 45; metformin with or without sulfonylurea

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: hypothetical
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	metformin with or without sulfonylurea; sulfonylurea may be reduced for hypoglycemia; lifestyle: not reported	233	233
A2	Insulin glargine Insulin glargine titrated	metformin with or without sulfonylurea; sulfonylurea may be reduced for hypoglycemia; lifestyle: not reported	234	223

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
age: 65 or older	n	49	56
age	mean (years)	57.6	58.3
age	sd (years)	9.72	9.08
asian	percent	6	6
black	percent	1
bmi	mean (kg/m2)	32	32
bmi	sd (kg/m2)	5	5
diabetes duration	mean (years)	8	8
diabetes duration	sd (years)	6	6
egfr: 30 to less than 60	n	18	16
egfr: 60 to less than 90	n	129	133
female	n	113	100
hba1c	mean (percent)	8.32	8.29
hba1c	sd (percent)	1.094	1.020
hispanic	percent	12	9
other background metformin alone	n	164	157
other race american indian alaska native	percent	0	0
other race other	percent	0	0
other sulfonylurea use	n	69	66
sbp	mean (mmHg)	135	133
sbp	sd (mmHg)	17	16
weight	mean (kg)	91.22	90.56
weight	sd (kg)	18.582	16.348
white	percent	82	85

Analyses this trial contributes to

Results

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

HbA1c change (11 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.47 percent	0.05		205	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-0.16 percent		-0.29 to -0.03		not stated; modified itt; registry:outcomes
26	A2	change	-1.31 percent	0.06		206	not stated; modified itt; registry:outcomes
84	A1	final	7.0 percent	0.1		173	hypothetical; completers; R0027747:Results
84	A1 vs A2	md	-0.18 percent	0.08	-0.33 to -0.02		hypothetical; modified itt; R0027747:Results
84	A1 vs A2	md	-0.20 percent	0.08	-0.35 to -0.05		hypothetical; completers; R0027747:Results
84	A1	change	-1.2 percent	0.1		233	hypothetical; modified itt; R0027747:Results
84	A1	final	7.1 percent	0.1		233	hypothetical; modified itt; R0027747:Results
84	A2	change	-1.0 percent	0.1		223	hypothetical; modified itt; R0027747:Results
84	A2	final	7.3 percent	0.1		223	hypothetical; modified itt; R0027747:Results
84	A2	final	7.2 percent	0.1		173	hypothetical; completers; R0027747:Results

Body weight change in kilograms (diabetes) (12 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-2.63 kg	0.20		207	not stated; modified itt; registry:outcomes
26	A1 vs A2	md	-4.05 kg		-4.57 to -3.52		not stated; modified itt; registry:outcomes
26	A2	change	1.42 kg	0.20		209	not stated; modified itt; registry:outcomes
84	A1 vs A2	md	-4.5 kg	0.3	-5.0 to -3.9		hypothetical; modified itt; R0027747:Results
84	A1	change	-2.1 kg	0.2		233	hypothetical; modified itt; R0027747:Results
84	A1	change	-2.3 kg	0.3		173	hypothetical; completers; R0027747:Results
84	A1 vs A2	md	-4.4 kg	0.5	-5.4 to -3.5		hypothetical; completers; R0027747:Results
84	A1	change	-2.5 kg	0.3			hypothetical; modified itt; background:metformin_only; R0027747:Results
84	A1 vs A2	md	-4.7 kg	0.4	-5.4 to -4.0		hypothetical; modified itt; background:metformin_only; R0027747:Results
84	A2	change	2.4 kg	0.2		223	hypothetical; modified itt; R0027747:Results
84	A2	change	2.1 kg	0.3		173	hypothetical; completers; R0027747:Results
84	A2	change	2.2 kg	0.3			hypothetical; modified itt; background:metformin_only; R0027747:Results

HbA1c below 7 percent (7 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	59.0		222	not stated; modified itt; R0024240:Table 3
26	A1	responders	62.2		209	not stated; modified itt; registry:outcomes
26	A1 vs A2	rd	12.5	3 to 22		not stated; modified itt; R0024240:Table 3
26	A2	responders	46.5		215	not stated; modified itt; R0024240:Table 3
26	A2	responders	54.1		207	not stated; modified itt; registry:outcomes
84	A1	responders	44.6			hypothetical; modified itt; R0027747:Results
84	A2	responders	36.8			hypothetical; modified itt; R0027747:Results

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-3.03 mmHg	16.57		233	not stated; modified itt; registry:outcomes
26	A2	change	-0.63 mmHg	14.88		222	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 / 233	not stated; modified itt; R0027747:Results
	A2	events				0 / 223	not stated; modified itt; R0027747:Results

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	11 / 233	not stated; safety; registry:adverse_events
A1	events	22 / 233	not stated; modified itt; R0027747:Table 1
A2	events	10 / 223	not stated; safety; registry:adverse_events
A2	events	23 / 223	not stated; modified itt; R0027747:Table 1

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	12 / 233	not stated; randomized; registry:flow
A1	events	16 / 233	not stated; modified itt; R0027747:Table 1
A2	events	4 / 223	not stated; modified itt; R0027747:Table 1
A2	events	2 / 234	not stated; randomized; registry:flow

Nausea (7 lines; O27A)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	13	233	not stated; modified itt; R0024240:Table 4
A1	events	12.9	233	not stated; modified itt; R0027747:Results
A1	events		30 / 233	not stated; safety; registry:adverse_events
A1	events		34 / 233	not stated; modified itt; R0027747:Table 1
A2	events		3 / 223	not stated; safety; registry:adverse_events
A2	events		3 / 223	not stated; modified itt; R0027747:Table 1
A2	events	1	223	not stated; modified itt; R0024240:Table 4

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	4			233	not stated; modified itt; R0024240:Table 4
	A2	events	1			223	not stated; modified itt; R0024240:Table 4

Diarrhea (7 lines; O27C)

Arm	Statistic	Estimate	Events / N	Detail
A1	events	9	233	not stated; modified itt; R0024240:Table 4
A1	events		28 / 233	not stated; modified itt; R0027747:Table 1
A1	events		20 / 233	not stated; safety; registry:adverse_events
A1	events	8.6	233	not stated; modified itt; R0027747:Results
A2	events		8 / 223	not stated; safety; registry:adverse_events
A2	events	4	223	not stated; modified itt; R0024240:Table 4
A2	events		13 / 223	not stated; modified itt; R0027747:Table 1

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	3			233	not stated; modified itt; R0024240:Table 4
	A2	events	2			223	not stated; modified itt; R0024240:Table 4

Gallbladder and biliary disease (5 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 233	not stated; safety; bile duct stone; registry:adverse_events
A1	events	1 / 233	not stated; modified itt; cholelithiasis; R0027747:Results
A1	events	0 / 233	not stated; safety; cholecystitis; registry:adverse_events
A2	events	1 / 223	not stated; safety; cholecystitis; registry:adverse_events
A2	events	1 / 223	not stated; safety; bile duct stone; registry:adverse_events

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 233	not stated; safety; oedematous pancreatitis; registry:adverse_events
	A2	events				0 / 223	not stated; safety; oedematous pancreatitis; registry:adverse_events