parallel randomized trial

NCT01003184

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea

Type 2 diabetes (adults)NCT01003184S001355

Design

Randomized: 222
Start year: 2009
Treatment: 26 weeks, follow-up 26 weeks
Countries
Sponsor: Amylin Pharmaceuticals and Eli Lilly and Company (industry)
Eligibility: age 18 or older; HbA1c 7.1 to 10.0 percent; BMI 25 to 45; metformin with or without SU

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: LOCF

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 dose halved at start; lifestyle: not reported	111	111
A2	Insulin detemir Insulin detemir once or twice daily	metformin with or without sulfonylurea; sulfonylurea dose halved at start; lifestyle: not reported	111	105

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 detemir A2
age: 18 to 65	n	74	78
age: 65 or older	n	37	27
age	mean (years)	59	58
age	sd (years)	10	10
asian	n	6	3
asian	percent	5	3
black	n	1	0
black	percent	1
bmi	mean (kg/m2)	33.7	33.7
bmi	sd (kg/m2)	4.7	4.7
diabetes duration	mean (years)	8	7
diabetes duration	sd (years)	6	5
female	n	40	33
hba1c	mean (percent)	8.37	8.35
hba1c	sd (percent)	0.85	0.88
other sulfonylurea use	percent	70	72
sbp	mean (mmHg)	134.4	138.1
sbp	sd (mmHg)	16.5	17.4
waist	mean (cm)	110.9	110.4
waist	sd (cm)	12.0	11.8
weight	mean (kg)	96.7	97.9
weight	sd (kg)	17.0	15.8
white	n	104	102
white	percent	94	97

Analyses this trial contributes to

Results

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

HbA1c change (6 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.30 percent	0.08	-1.45 to -1.14	111	not stated; modified itt; R0027663:Table 1
26	A1	change	-1.32 percent	0.076		95	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-0.42 percent		-0.63 to -0.21		not stated; modified itt; R0027663:Table 1
26	A1 vs A2	md	-0.41 percent		-0.62 to -0.20		not stated; full analysis; registry:outcomes
26	A2	change	-0.88 percent	0.08	-1.03 to -0.72	105	not stated; modified itt; R0027663:Table 1
26	A2	change	-0.91 percent	0.077		96	not stated; full analysis; registry:outcomes

Body weight change in kilograms (diabetes) (6 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-2.7 kg	0.3	-3.4 to -2.0	111	not stated; modified itt; R0027663:Table 1
26	A1	change	-2.79 kg	0.347		96	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-3.5 kg		-4.4 to -2.6		not stated; modified itt; R0027663:Table 1
26	A1 vs A2	md	-3.67 kg		-4.63 to -2.71		not stated; full analysis; registry:outcomes
26	A2	change	0.8 kg	0.4	0.1 to 1.5	105	not stated; modified itt; R0027663:Table 1
26	A2	change	0.88 kg	0.351		98	not stated; full analysis; registry:outcomes

HbA1c below 7 percent (5 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	51.4	41.7 to 61.0	111	not stated; full analysis; registry:outcomes
26	A1	responders	51		111	not stated; modified itt; R0027663:Figure 2
26	A1 vs A2	or	2.21	1.24 to 3.96		not stated; full analysis; registry:outcomes
26	A2	responders	34		105	not stated; modified itt; R0027663:Figure 2
26	A2	responders	34.3	25.3 to 44.2	105	not stated; full analysis; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 111	not stated; modified itt; R0027663:Table 2
A1	events	5 / 111	not stated; modified itt; R0027663:Table 2
A2	events	0 / 105	not stated; modified itt; R0027663:Table 2
A2	events	6 / 105	not stated; modified itt; R0027663:Table 2

Level 2 or 3 hypoglycemia (episode rate) (1 lines; O04B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1 vs A2	rate ratio	0.58		0.19 to 1.72		not stated; full analysis; registry:outcomes

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-6.8 mmHg		-9.4 to -4.2	111	not stated; modified itt; R0027663:Table 1
26	A1	change	-7.37 mmHg	1.342		95	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-4.4 mmHg		-7.9 to -1.0		not stated; modified itt; R0027663:Table 1
26	A1 vs A2	md	-4.72 mmHg		-8.37 to -1.07		not stated; full analysis; registry:outcomes
26	A2	change	-2.65 mmHg	1.339		98	not stated; full analysis; registry:outcomes
26	A2	change	-2.4 mmHg		-5.0 to 0.3	105	not stated; modified itt; R0027663:Table 1

Acute kidney injury (2 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 111	not stated; full analysis; renal injury; registry:adverse_events
	A2	events				1 / 105	not stated; full analysis; renal injury; registry:adverse_events

Health related quality of life total score (any instrument) (5 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	6.2 points	1.0	4.2 to 8.2	111	not stated; modified itt; R0027663:Results
26	A1	change	4.2 points	1.1	2.0 to 6.5	111	not stated; modified itt; R0027663:Results
26	A1 vs A2	md	points		0.7 to 6.1		not stated; modified itt; R0027663:Results
26	A2	change	2.8 points	1.1	0.7 to 4.9	105	not stated; modified itt; R0027663:Results
26	A2	change	1.8 points	1.2	-0.6 to 4.1	105	not stated; modified itt; R0027663:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 111	not stated; modified itt; R0027663:Table 2
	A2	events				6 / 105	not stated; modified itt; R0027663:Table 2

Discontinuation due to adverse events (5 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	12 / 111	not stated; modified itt; R0027663:Table 2
A1	events	12 / 111	not stated; modified itt; R0027663:Figure 1
A2	events	5 / 105	not stated; modified itt; R0027663:Table 2
A2	events	5 / 105	not stated; modified itt; R0027663:Figure 1
A2	events	5 / 111	not stated; randomized; registry:flow

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	20 / 111	not stated; modified itt; R0027663:Table 2
A1	events	53 / 111	not stated; full analysis; registry:adverse_events
A2	events	2 / 105	not stated; modified itt; R0027663:Table 2
A2	events	12 / 105	not stated; full analysis; registry:adverse_events

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				16 / 111	not stated; modified itt; R0027663:Table 2
	A2	events				9 / 105	not stated; modified itt; R0027663:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				19 / 111	not stated; modified itt; R0027663:Table 2
	A2	events				11 / 105	not stated; modified itt; R0027663:Table 2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				10 / 111	not stated; modified itt; R0027663:Table 2
	A2	events				3 / 105	not stated; modified itt; R0027663:Table 2

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	2			111	not stated; modified itt; R0027663:Results
	A2	events				0 / 105	not stated; modified itt; R0027663:Results