parallel randomized trial

PREVAIL

Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)

Design

Randomized: 103
Start year: 2014
Treatment: 8 weeks, follow-up 20 weeks
Countries: Canada (1 sites)
Sponsor: Mount Sinai Hospital, Canada (non industry)
Eligibility: age 30 to 80; T2D 7 years or less; A1c 6.0 to 9.5 percent off drugs or 5.5 to 9.0 on up to 2 oral drugs

Arm	Treatment	Background	Randomized	Analyzed
A1	Standard care or no added treatment Glargine	insulin glargine at bedtime from 0.12 U/kg titrated to fasting glucose 5.3 mmol/L or less; lifestyle: standard	33	33
A2	Insulin lispro (prandial) Glargine + Lispro	insulin glargine at bedtime titrated to fasting glucose 5.3 mmol/L or less; lifestyle: standard	35	35
A3	Exenatide 10 ug subcutaneous twice daily Glargine + Exenatide	insulin glargine at bedtime titrated to fasting glucose 5.3 mmol/L or less; lifestyle: standard	35	34

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Standard care or no added treatment A1	Insulin lispro (prandial) A2	Exenatide 10 ug subcutaneous twice daily A3	Whole trial ALL
age	mean (years)	58	59	56
age	sd (years)	10	9	10
bmi	mean (kg/m2)	32.3	32.9	31.7
bmi	sd (kg/m2)	6.6	8.4	7.6
diabetes duration	median (years)	3.0	4.0	3.9
diabetes duration	q1 (years)	1.9	1.9	1.5
diabetes duration	q3 (years)	5.5	5.8	5.3
established cvd	n	1	2	1
established cvd	percent	4	8	4
female	n				44
hba1c	mean (percent)	6.6	6.5	6.6
hba1c	sd (percent)	0.7	0.8	0.6
other male	n	19	16	23
other male	percent	57.6	45.7	67.7
other race other	n	8	10	8
other race other	percent	24.2	28.6	23.5
other race south asian	n	2	4	6
other race south asian	percent	6.1	11.4	17.7
sbp	mean (mmHg)	133	135	137
sbp	sd (mmHg)	18.7	15.2	15.5
waist	mean (cm)	108.4	104.7	107.0
waist	sd (cm)	14.5	15.0	16.9
weight	mean (kg)	93.7	88.9	93.0
weight	sd (kg)	18.1	18.2	23.3
white	n	23	21	20
white	percent	69.7	60.0	58.8

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
8	A1	final	6.2 percent	0.07		33	not stated; modified itt; R0010144:Table 2
8	A1	change	-0.3 percent		-0.5 to -0.1	33	not stated; modified itt; R0010144:Results
8	A2	final	6.0 percent	0.06		35	not stated; modified itt; R0010144:Table 2
8	A2	change	-0.5 percent		-0.7 to -0.3	35	not stated; modified itt; R0010144:Results
8	A3	final	5.9 percent	0.07		34	not stated; modified itt; R0010144:Table 2
8	A3	change	-0.7 percent		-0.8 to -0.5	34	not stated; modified itt; R0010144:Results
20	A1	final	6.7 percent	0.1		33	not stated; modified itt; R0010144:Table 2
20	A2	final	6.6 percent	0.09		35	not stated; modified itt; R0010144:Table 2
20	A3	final	6.6 percent	0.1		34	not stated; modified itt; R0010144:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
8	A1	final	93.5 kg	0.4	33	not stated; modified itt; R0010144:Table 2
8	A2	final	92.7 kg	0.4	35	not stated; modified itt; R0010144:Table 2
8	A3	final	90.9 kg	0.4	34	not stated; modified itt; R0010144:Table 2
20	A1	final	92.3 kg	0.6	33	not stated; modified itt; R0010144:Table 2
20	A2	final	91.8 kg	0.5	35	not stated; modified itt; R0010144:Table 2
20	A3	final	90.8 kg	0.5	34	not stated; modified itt; R0010144:Table 2

Level 2 or 3 hypoglycemia (participants) (15 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	1 / 33	not stated; modified itt; R0010144:Table 3
A1	events	15 / 33	not stated; modified itt; R0010144:Table 3
A1	events	10 / 33	not stated; modified itt; R0010144:Table 3
A1	events	0 / 33	not stated; modified itt; R0010144:Supplementary Table 1
A1	events	16 / 33	not stated; modified itt; R0010144:Supplementary Table 1
A2	events	26 / 35	not stated; modified itt; R0010144:Supplementary Table 1
A2	events	8 / 35	not stated; modified itt; R0010144:Table 3
A2	events	0 / 35	not stated; modified itt; R0010144:Supplementary Table 1
A2	events	12 / 35	not stated; modified itt; R0010144:Table 3
A2	events	26 / 35	not stated; modified itt; R0010144:Table 3
A3	events	0 / 34	not stated; modified itt; R0010144:Supplementary Table 1
A3	events	5 / 34	not stated; modified itt; R0010144:Table 3
A3	events	22 / 34	not stated; modified itt; R0010144:Supplementary Table 1
A3	events	6 / 34	not stated; modified itt; R0010144:Table 3
A3	events	23 / 34	not stated; modified itt; R0010144:Table 3

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

Arm	Statistic	Estimate	Detail
A1	rate	0.6	not stated; modified itt; R0010144:Table 3
A2	rate	2.1	not stated; modified itt; R0010144:Table 3
A3	rate	1.1	not stated; modified itt; R0010144:Table 3

Systolic blood pressure change (9 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
8	A1	change	-3.7 mmHg		-10.2 to 2.7	24	not stated; other; R0009210:Table 2
8	A1	final	130 mmHg	2.7			not stated; other; R0009210:Table 3
8	A2	change	-2.3 mmHg		-9.0 to 4.5	24	not stated; other; R0009210:Table 2
8	A2	final	133 mmHg	2.7			not stated; other; R0009210:Table 3
8	A3	change	-8.1 mmHg		-13.9 to -2.4	25	not stated; other; R0009210:Table 2
8	A3	final	128 mmHg	2.6			not stated; other; R0009210:Table 3
20	A1	final	133 mmHg	2.1			not stated; other; R0009210:Table 3
20	A2	final	132 mmHg	2.0			not stated; other; R0009210:Table 3
20	A3	final	128 mmHg	1.9			not stated; other; R0009210:Table 3

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; modified itt; R0010144:Supplementary Table 1
A2	events	0 / 35	not stated; modified itt; R0010144:Supplementary Table 1
A3	events	1 / 34	not stated; modified itt; R0010144:Supplementary Table 1

Intestinal obstruction or ileus (3 lines; O37B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; modified itt; bowel obstruction; R0010144:Supplementary Table 1
A2	events	1 / 35	not stated; modified itt; bowel obstruction; R0010144:Supplementary Table 1
A3	events	0 / 34	not stated; modified itt; bowel obstruction; R0010144:Supplementary Table 1