parallel randomized trial

GRADE

Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study

Design

Randomized: 5,047
Start year: 2013
Treatment: 365.26 weeks, follow-up 365.26 weeks
Countries: United States (36 sites)
Sponsor: GRADE Study Group (mixed)
Eligibility: age at diagnosis 30 or older; T2D under 10 years; HbA1c 6.8 to 8.5 percent; metformin 1000 mg/day or more

Arm	Treatment	Background	Randomized	Analyzed
A1	Insulin glargine Insulin glargine U-100	metformin; lifestyle: not reported	1,263	1,263
A2	Glimepiride Glimepiride	metformin; lifestyle: not reported	1,254	1,254
A3	Liraglutide 1.8 mg subcutaneous once daily Liraglutide	metformin; lifestyle: not reported	1,262	1,262
A4	Sitagliptin Sitagliptin	metformin; lifestyle: not reported	1,268	1,268

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

Characteristic	Statistic	Insulin glargine A1	Glimepiride A2	Liraglutide 1.8 mg subcutaneous once daily A3	Sitagliptin A4
age	mean (years)	57.0	57.1	57.4	57.2
age	sd (years)	9.9	10.1	9.9	10.1
asian	n	34	47	47	54
black	n	253	271	251	225
bmi	mean (kg/m2)	34.4	34.3	34.5	34.1
bmi	sd (kg/m2)	6.8	6.8	6.7	6.7
diabetes duration	mean (years)	4.2	4.3	4.2	4.2
diabetes duration	sd (years)	2.7	2.8	2.7	2.7
egfr: less than 60	n	34	27	32	27
egfr: less than 60	percent	2.8	2.2	2.8	2.2
egfr	mean (mL/min/1.73 m2)	94.6	95.2	94.3	95.3
egfr	sd (mL/min/1.73 m2)	16.7	16.9	17.3	16.3
female	n	452	476	439	470
hba1c	mean (percent)	7.5	7.5	7.5	7.5
hba1c	sd (percent)	0.5	0.5	0.5	0.5
hispanic	n	209	227	206	234
hispanic	percent	17.3	18.8	17.9	19.0
other race american indian alaska native	n	33	30	40	34
other race multiple	n	82	71	82	84
other race native hawaiian pacific islander	n	5	7	8	8
sbp	mean (mmHg)	128.5	128.2	128.3	128.3
sbp	sd (mmHg)	14.9	14.4	14.9	14.8
uacr: moderately elevated	n	170	170	176	172
uacr: moderately elevated	percent	14.0	14.0	15.3	13.9
uacr: severely elevated	n	17	27	21	18
uacr: severely elevated	percent	1.4	2.2	1.8	1.5
uacr	median (mg/g)	6.7	6.1	6.6	6.1
uacr	q1 (mg/g)	3.2	2.9	3.1	3.1
uacr	q3 (mg/g)	18.0	16.7	18.7	15.1
white	n	837	808	815	854

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

Level 2 or 3 hypoglycemia (participants) (20 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	73 / 1216	hypothetical; per protocol; R0020895:Table 2
A1	events	17 / 1263	not stated; safety; registry:adverse_events
A1	events	10 / 1216	hypothetical; per protocol; R0020895:Table 2
A1	events	659 / 1216	hypothetical; per protocol; R0020895:Table 2
A1	events	765 / 1216	hypothetical; per protocol; R0020895:Table 2
A1	events	522 / 1216	hypothetical; per protocol; R0020895:Table 2
A1	events	311 / 1216	hypothetical; per protocol; R0020895:Table 2
A2	events	16 / 1219	hypothetical; per protocol; R0020895:Table 2
A2	events	833 / 1219	hypothetical; per protocol; R0020895:Table 2
A2	events	915 / 1219	hypothetical; per protocol; R0020895:Table 2
A2	events	687 / 1219	hypothetical; per protocol; R0020895:Table 2
A2	events	311 / 1219	hypothetical; per protocol; R0020895:Table 2
A2	events	106 / 1219	hypothetical; per protocol; R0020895:Table 2
A2	events	28 / 1254	not stated; safety; registry:adverse_events
A3	events	12 / 1262	not stated; safety; registry:adverse_events
A3	events	6 / 1156	hypothetical; per protocol; R0020895:Table 2
A3	events	375 / 1156	hypothetical; per protocol; R0020895:Table 2
A4	events	9 / 1268	not stated; safety; registry:adverse_events
A4	events	361 / 1239	hypothetical; per protocol; R0020895:Table 2
A4	events	4 / 1239	hypothetical; per protocol; R0020895:Table 2

Level 2 or 3 hypoglycemia (episode rate) (4 lines; O04B)

Arm	Statistic	Events / N	Detail
A1	rate	1263	not stated; safety; registry:adverse_events
A2	rate	1254	not stated; safety; registry:adverse_events
A3	rate	1262	not stated; safety; registry:adverse_events
A4	rate	1268	not stated; safety; registry:adverse_events

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	42 / 1263	not stated; safety; registry:adverse_events
A2	events	43 / 1254	not stated; safety; registry:adverse_events
A3	events	27 / 1262	not stated; safety; registry:adverse_events
A4	events	41 / 1268	not stated; safety; registry:adverse_events

Hospitalization for heart failure (4 lines; O23)

Arm	Statistic	Events / N	Detail
A1	events	26 / 1263	not stated; safety; heart failure; registry:adverse_events
A2	events	30 / 1254	not stated; safety; heart failure; registry:adverse_events
A3	events	14 / 1262	not stated; safety; heart failure; registry:adverse_events
A4	events	30 / 1268	not stated; safety; heart failure; registry:adverse_events

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	259 / 1263	not stated; safety; registry:adverse_events
A2	events	315 / 1254	not stated; safety; registry:adverse_events
A3	events	204 / 1262	not stated; safety; registry:adverse_events
A4	events	272 / 1268	not stated; safety; registry:adverse_events

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	10 / 1263	not stated; safety; pancreatitis; registry:adverse_events
A2	events	16 / 1254	not stated; safety; pancreatitis; registry:adverse_events
A3	events	11 / 1262	not stated; safety; pancreatitis; registry:adverse_events
A4	events	6 / 1268	not stated; safety; pancreatitis; registry:adverse_events

Thyroid cancer (any) (4 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 1263	not stated; safety; registry:adverse_events
A2	events	2 / 1254	not stated; safety; registry:adverse_events
A3	events	2 / 1262	not stated; safety; registry:adverse_events
A4	events	1 / 1268	not stated; safety; registry:adverse_events

Pancreatic cancer (4 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	6 / 1263	not stated; safety; registry:adverse_events
A2	events	5 / 1254	not stated; safety; registry:adverse_events
A3	events	3 / 1262	not stated; safety; registry:adverse_events
A4	events	3 / 1268	not stated; safety; registry:adverse_events