parallel randomized trial

DURATION-NEO-2

A Randomized, Long-Term, Open-Label, 3-Arm, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Sitagliptin and Placebo in Subjects With Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT01652729S001157

Design

Randomized: 365
Start year: 2013
Treatment: 28 weeks, follow-up 28 weeks
Countries: United States (81 sites)
Sponsor: AstraZeneca (industry)
Eligibility: age 18 or older; HbA1c 7.1 to 11.0 percent; BMI 45 or lower; metformin 1500 mg or more

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Exenatide extended release 2 mg subcutaneous once weekly Exenatide QW suspension autoinjector 2 mg	metformin; lifestyle: not reported	182	181
A2	Sitagliptin Sitagliptin 100 mg	metformin; lifestyle: not reported	122	122
A3	Placebo Placebo	metformin 1500 mg/d or more; lifestyle: not reported	61	61

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	Sitagliptin A2	Placebo A3
age	mean (years)	53.4	54.3	53.4
age	sd (years)	9.8	9.0	9.5
asian	n	9	2	3
asian	percent	5.0	1.6	4.9
black	n	24	18	7
black	percent	13.3	14.8	11.5
bmi	mean (kg/m2)	32.1	31.6	31.5
bmi	sd (kg/m2)	5.4	5.8	5.1
diabetes duration	mean (years)	8.5	7.9	8.7
diabetes duration	sd (years)	6.3	4.6	5.8
egfr: 30 to less than 60	n	1	3	0
egfr: 60 to less than 90	n	75	48	24
female	n	92	56	24
hba1c	mean (percent)	8.4	8.5	8.5
hba1c	sd (percent)	1.0	1.0	1.0
hispanic	n	111	77	32
hispanic	percent	61.3	63.1	52.5
other male	n	89	66	37
other male	percent	49.2	54.1	60.7
other race other	n	0	4	1
other race other	percent	0.0	3.3	1.6
sbp	mean (mmHg)	127.6	128.9	127.7
sbp	sd (mmHg)	12.8	12.4	15.5
uacr	mean (mg/g)	11.1	13.0	12.2
waist	mean (cm)	107.1	105.3	105.9
waist	sd (cm)	13.8	14.2	13.3
weight	mean (kg)	89.2	88.1	89.0
weight	sd (kg)	21.4	20.3	20.1
white	n	148	98	50
white	percent	81.8	80.3	82.0

Analyses this trial contributes to

Results

68 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
28	A1 vs A2	md	-0.38 percent		-0.70 to -0.06		not stated; modified itt; R0010641:Table 2
28	A1	change	-1.13 percent	0.11		181	not stated; modified itt; R0010641:Table 2
28	A1 vs A3	md	-0.72 percent		-1.15 to -0.30		not stated; modified itt; R0010641:Table 2
28	A2	change	-0.75 percent	0.13		122	not stated; modified itt; R0010641:Table 2
28	A2 vs A3	md	-0.34 percent		-0.79 to 0.11		not stated; modified itt; registry:outcomes
28	A3	change	-0.40 percent	0.19		61	not stated; modified itt; R0010641:Table 2

Body weight change in kilograms (diabetes) (5 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	change	-1.1 kg	0.3		181	not stated; modified itt; R0010641:Table 2
28	A1 vs A2	md	0.1 kg		-0.7 to 0.9		not stated; modified itt; R0010641:Table 2
28	A1 vs A3	md	-1.3 kg		-2.3 to -0.2		not stated; modified itt; R0010641:Table 2
28	A2	change	-1.2 kg	0.3		122	not stated; modified itt; R0010641:Table 2
28	A3	change	0.2 kg	0.5		61	not stated; modified itt; R0010641:Table 2

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
28	A1	responders	43.1	181	not stated; modified itt; R0010641:Results
28	A2	responders	32.0	122	not stated; modified itt; R0010641:Results
28	A3	responders	24.6	61	not stated; modified itt; R0010641:Results

Level 2 or 3 hypoglycemia (participants) (6 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 181	not stated; safety; R0010641:Table 3
A1	events	0 / 181	not stated; safety; R0010641:Table 3
A2	events	1 / 122	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3

Systolic blood pressure change (5 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	change	1.2 mmHg	0.9		181	not stated; modified itt; R0010641:Table 2
28	A1 vs A2	md	0.5 mmHg		-2.3 to 3.2		not stated; modified itt; R0010641:Table 2
28	A1 vs A3	md	-1.2 mmHg		-4.9 to 2.6		not stated; modified itt; R0010641:Table 2
28	A2	change	0.8 mmHg	1.1		122	not stated; modified itt; R0010641:Table 2
28	A3	change	2.4 mmHg	1.7		61	not stated; modified itt; R0010641:Table 2

Physical functioning (any instrument) (5 lines; O24B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	change	4.4 points	1.3		181	not stated; modified itt; R0010641:Supplement Table S1
28	A1 vs A2	md	0.6 points		-3.1 to 4.3		not stated; modified itt; R0010641:Supplement Table S1
28	A1 vs A3	md	-0.7 points		-5.7 to 4.3		not stated; modified itt; R0010641:Supplement Table S1
28	A2	change	3.8 points	1.4		122	not stated; modified itt; R0010641:Supplement Table S1
28	A3	change	5.1 points	2.2		61	not stated; modified itt; R0010641:Supplement Table S1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	change	2.3 points	1.1		181	not stated; modified itt; R0010641:Supplement Table S1
28	A1 vs A2	md	-1.3 points		-4.2 to 1.7		not stated; modified itt; R0010641:Supplement Table S1
28	A1 vs A3	md	-1.0 points		-5.0 to 3.0		not stated; modified itt; R0010641:Supplement Table S1
28	A2	change	3.6 points	1.1		122	not stated; modified itt; R0010641:Supplement Table S1
28	A3	change	3.3 points	1.8		61	not stated; modified itt; R0010641:Supplement Table S1

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 181	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A3	events	2 / 61	not stated; safety; R0010641:Table 3

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 181	not stated; safety; R0010641:Table 3
A1	events	4 / 182	not stated; randomized; registry:flow
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; randomized; registry:flow
A3	events	3 / 61	not stated; safety; R0010641:Table 3
A3	events	3 / 61	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	16 / 181	not stated; safety; R0010641:Table 3
A2	events	2 / 122	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	6 / 181	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	5 / 181	not stated; safety; R0010641:Table 3
A2	events	2 / 122	not stated; safety; R0010641:Table 3
A3	events	1 / 61	not stated; safety; R0010641:Table 3

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 181	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3

Medullary thyroid carcinoma (3 lines; O32A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 181	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3

Thyroid cancer (any) (3 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 181	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3

Intestinal obstruction or ileus (3 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 181	not stated; safety; abdominal hernia obstructive; registry:adverse_events
A2	events	0 / 122	not stated; safety; abdominal hernia obstructive; registry:adverse_events
A3	events	0 / 61	not stated; safety; abdominal hernia obstructive; registry:adverse_events

Pancreatic cancer (3 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 181	not stated; safety; R0010641:Table 3
A2	events	0 / 122	not stated; safety; R0010641:Table 3
A3	events	0 / 61	not stated; safety; R0010641:Table 3