parallel randomized trial

RISE Adult

Restoring Insulin Secretion Adult Medication Study

Design

Randomized: 267
Start year: 2013
Treatment: 52.14 weeks, follow-up 91.245 weeks
Countries: (3 sites)
Sponsor: RISE Study Group (non industry)
Eligibility: age 20 to 65; BMI 25 to under 50; IGT or drug naive type 2 diabetes under 12 months; HbA1c 7 or lower

Arm	Treatment	Background	Randomized
A1	Metformin Metformin alone	lifestyle: not reported	65
A2	Glargine then metformin Glargine followed by metformin	lifestyle: not reported	67
A3	Placebo Placebo	lifestyle: not reported	67
A4	Liraglutide maximum tolerated dose injection once daily Liraglutide plus metformin	lifestyle: not reported	68

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

Characteristic	Statistic	Metformin A1	Glargine then metformin A2	Placebo A3	Liraglutide maximum tolerated dose injection once daily A4	Whole trial ALL
age	mean (years)	55.2	53.5	52.8	54.0	53.9
age	sd (years)	8.2	9.3	10.0	8.1	8.9
black	n	19	21	21	20	81
bmi	mean (kg/m2)	35.0	35.0	34.4	35.6	35.0
bmi	sd (kg/m2)	5.1	5.9	5.9	5.8	5.7
female	n	37	23	25	29	114
hba1c	mean (percent)	5.77	5.80	5.73	5.69	5.75
hba1c	sd (percent)	0.40	0.33	0.43	0.39	0.39
hispanic	n	6	5	11	6	28
white: non-Hispanic white	n	34	37	30	40	141

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

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 65	not stated; randomized; registry:adverse_events
A2	events	0 / 67	not stated; randomized; registry:adverse_events
A3	events	0 / 67	not stated; randomized; registry:adverse_events
A4	events	0 / 68	not stated; randomized; registry:adverse_events

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	5 / 65	not stated; randomized; registry:adverse_events
A2	events	2 / 67	not stated; randomized; registry:adverse_events
A3	events	3 / 67	not stated; randomized; registry:adverse_events
A4	events	7 / 68	not stated; randomized; registry:adverse_events

Gallbladder and biliary disease (4 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 65	not stated; randomized; Cholelithiasis; registry:adverse_events
A2	events	0 / 67	not stated; randomized; Cholelithiasis; registry:adverse_events
A3	events	0 / 67	not stated; randomized; Cholelithiasis; registry:adverse_events
A4	events	1 / 68	not stated; randomized; Cholelithiasis; registry:adverse_events