parallel randomized trial

DURATION-NEO-1

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

Type 2 diabetes (adults)NCT01652716S001982

Design

Randomized: 377
Start year: 2013
Treatment: 28 weeks, follow-up 28 weeks
Countries: United States (65 sites)
Sponsor: AstraZeneca (industry)
Eligibility: Adults 18 or older; HbA1c 7.1 to 11.0 percent; diet and exercise or stable metformin, sulfonylurea, pioglitazone

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: not stated
Analysis population: modified itt
Missing data: MMRM; LOCF

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide QWS-AI 2 mg	diet and exercise or stable metformin, sulfonylurea, pioglitazone; lifestyle: none	229	229
A2	Exenatide 10 ug subcutaneous twice daily Exenatide BID 10 ug	diet and exercise or stable metformin, sulfonylurea, pioglitazone; lifestyle: none	148	146

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: 65 or older	n	47	28
age: less than 65	n	182	118
age	mean (years)	56	57
age	sd (years)	10	9
asian	n	17	8
asian	percent	7	6
black	n	38	23
black	percent	17	16
bmi	mean (kg/m2)	33	33
bmi	sd (kg/m2)	6	5
diabetes duration	mean (years)	9	8
diabetes duration	sd (years)	6	6
egfr: 30 to 59	n	29	15
egfr: 30 to 59	percent	13	10
egfr: 60 to 89	n	113	76
egfr: 60 to 89	percent	49	52
egfr: 90 or more	n	85	55
egfr: 90 or more	percent	37	38
female	n	81	54
hba1c	mean (percent)	8.5	8.5
hba1c	sd (percent)	1.0	1.0
hispanic	n	54	34
hispanic	percent	24	23
other background: diet and exercise	n	31	17
other background: diet and exercise	percent	14	12
other background: metformin and thiazolidinedione	n	5	4
other background: metformin and thiazolidinedione	percent	2	3
other background: metformin only	n	102	65
other background: metformin only	percent	45	45
other background: sulfonylurea and metformin and thiazolidinedione	n	4	2
other background: sulfonylurea and metformin and thiazolidinedione	percent	2	1
other background: sulfonylurea and metformin	n	76	52
other background: sulfonylurea and metformin	percent	33	36
other background: sulfonylurea and thiazolidinedione	n	1	0
other background: sulfonylurea and thiazolidinedione	percent		0
other background: sulfonylurea only	n	8	6
other background: sulfonylurea only	percent	4	4
other background: thiazolidinedione only	n	2	0
other background: thiazolidinedione only	percent	1	0
other race american indian alaska native	n	2	3
other race american indian alaska native	percent	1	2
other race native hawaiian pacific islander	n	1	0
other race native hawaiian pacific islander	percent		0
other race other	n	3	2
other race other	percent	1	1
other sulfonylurea use	n	89	60
other sulfonylurea use	percent	39	41
sbp	mean (mmHg)	129.8	130.3
sbp	se (mmHg)	1.0	1.2
weight	mean (kg)	97	97
weight	sd (kg)	23	19
white	n	168	110
white	percent	73	75

Results

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

HbA1c change (20 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	change	-1.59 percent				not stated; modified itt; R0014206:Figure 2A
20	A2	change	-1.10 percent				not stated; modified itt; R0014206:Figure 2A
24	A1	change	-1.54 percent				not stated; modified itt; R0014206:Figure 2A
24	A2	change	-1.09 percent				not stated; modified itt; R0014206:Figure 2A
28	A1 vs A2	md	-0.37 percent	0.13	-0.63 to -0.10		not stated; modified itt; R0014206:Results
28	A1	change	-1.45 percent		-1.65 to -1.25		hypothetical; modified itt; R0022632:Results
28	A1	change	-1.4 percent	0.1			hypothetical; modified itt; R0022632:Results
28	A1 vs A2	md	-0.41 percent		-0.68 to -0.14		hypothetical; modified itt; R0022632:Results
28	A1	change	-1.39 percent	0.09		229	not stated; modified itt; R0014206:Results
28	A1 vs A2	md	-0.23 percent		-0.57 to 0.11		not stated; modified itt; background:no_sulfonylurea; R0014206:Supplement Figure S1A
28	A1 vs A2	md	-0.52 percent		-0.94 to -0.11		not stated; modified itt; background:sulfonylurea; R0014206:Supplement Figure S1A
28	A1	change	-1.1 percent				not stated; modified itt; race:asian; R0014206:Results
28	A1	change	-1.0 percent				not stated; modified itt; race:black; R0014206:Results
28	A1	change	-1.5 percent				not stated; modified itt; race:white; R0014206:Results
28	A2	change	-1.1 percent	0.1			hypothetical; modified itt; R0022632:Results
28	A2	change	-1.1 percent				not stated; modified itt; race:black; R0014206:Results
28	A2	change	-1.04 percent		-1.28 to -0.80		hypothetical; modified itt; R0022632:Results
28	A2	change	-1.02 percent	0.11		146	not stated; modified itt; R0014206:Results
28	A2	change	-0.9 percent				not stated; modified itt; race:asian; R0014206:Results
28	A2	change	-1.0 percent				not stated; modified itt; race:white; R0014206:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1 vs A2	md	0.55 kg		-0.27 to 1.36		hypothetical; modified itt; R0022632:Results
28	A1	change	-1.49 kg	0.28		229	not stated; modified itt; R0014206:Results
28	A1 vs A2	md	0.4 kg	0.4			not stated; modified itt; R0014206:Results
28	A1 vs A2	md	0.40 kg	0.4497	-0.48 to 1.28		not stated; modified itt; registry:outcomes
28	A1 vs A2	md	1.30 kg		0.17 to 2.43		not stated; modified itt; background:no_sulfonylurea; R0014206:Supplement Figure S1C
28	A1 vs A2	md	-0.86 kg		-2.24 to 0.53		not stated; modified itt; background:sulfonylurea; R0014206:Supplement Figure S1C
28	A2	change	-1.89 kg	0.36		146	not stated; modified itt; R0014206:Results

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	responders	49.3			229	not stated; modified itt; R0014206:Results
28	A2	responders	43.2			146	not stated; modified itt; R0014206:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 229	not stated; safety; R0014206:Results
	A2	events				0 / 146	not stated; safety; R0014206:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Detail
28	A1	change	-0.8 mmHg	1.1	not stated; modified itt; R0014206:Results
28	A1 vs A2	md	0.8 mmHg	1.6	not stated; modified itt; R0014206:Results
28	A2	change	-1.6 mmHg	1.4	not stated; modified itt; R0014206:Results
28	A2	change	-3.0 mmHg		hypothetical; modified itt; R0022632:Results

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 146	not stated; safety; R0014206:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 229	not stated; safety; R0022632:Table 1
	A2	events				0 / 146	not stated; safety; R0022632:Table 1

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 229	not stated; safety; R0014206:Table 2
	A2	events				7 / 146	not stated; safety; R0014206:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	11 / 229	not stated; safety; R0014206:Table 2
A1	events	6 / 229	not stated; randomized; R0014206:Results
A2	events	11 / 146	not stated; safety; R0014206:Table 2
A2	events	8 / 148	not stated; randomized; R0014206:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	22 / 229	not stated; safety; R0014206:Table 2
A2	events	31 / 146	not stated; safety; R0014206:Table 2
A2	events	30 / 146	not stated; safety; R0022632:Table 1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 229	not stated; safety; R0014206:Table 2
	A2	events				9 / 146	not stated; safety; R0014206:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 229	not stated; safety; R0014206:Table 2
	A2	events				17 / 146	not stated; safety; R0014206:Table 2

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 229	not stated; safety; pancreatitis; R0014206:Results