parallel randomized trial

S002904

Type 2 diabetes (adults)S002904

Design

Randomized: 120
Start year: 2014
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (7 sites)
Sponsor: Kanazawa University, ERA-DM Study Group (mixed)
Eligibility: age 20 or older; HbA1c 8.0 percent or more; diet or oral drugs; no insulin or GLP-1 RA

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: full analysis
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide after insulin degludec 0.9 mg injection once daily Insulin degludec then liraglutide relay	diet with or without oral drugs, DPP-4 inhibitors stopped; lifestyle: standard	60	59
A2	Liraglutide 0.9 mg injection once daily Liraglutide 0.9 mg first	diet with or without oral drugs, DPP-4 inhibitors stopped; lifestyle: standard	60	57

Baseline characteristics

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

Characteristic	Statistic	Liraglutide after insulin degludec 0.9 mg injection once daily A1	Liraglutide 0.9 mg injection once daily A2
age	median (years)	61.0	62.0
age	q1 (years)	47.0	47.0
age	q3 (years)	71.0	68.0
bmi	median (kg/m2)	25.1	26.2
bmi	q1 (kg/m2)	22.3	23.3
bmi	q3 (kg/m2)	28.6	30.1
diabetes duration	median (years)	5.0	3.0
diabetes duration	q1 (years)	0.0	0.0
diabetes duration	q3 (years)	11.0	12.8
female	n	20	24
hba1c	median (percent)	9.8	9.7
hba1c	q1 (percent)	9.0	8.8
hba1c	q3 (percent)	11.2	11.0
metformin use	n	17	16
other dpp4i use	n	21	19
other newly diagnosed	n	20	19
other newly diagnosed	percent	33.9	33.3
other no oral drug	n	27	28
other sulfonylurea use	n	10	12
sbp	median (mmHg)	125.0	127.0
sbp	q1 (mmHg)	114.0	118.5
sbp	q3 (mmHg)	139.0	138.0
sglt2i use	n	3	1
waist	median (cm)	91.0	94.8
waist	q1 (cm)	82.0	85.9
waist	q3 (cm)	101.0	103.6
weight	median (kg)	65.4	70.1
weight	q1 (kg)	56.6	60.2
weight	q3 (kg)	73.9	83.8

Analyses this trial contributes to

Results

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

HbA1c change (28 lines; O01)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	change	percent	14	not stated; other; bmi:25.7_to_29.0; R0003210:Supplement Table S6
24	A1	change	percent		not stated; per protocol; R0003210:Results
24	A1	change	percent	19	not stated; other; bmi:less_than_22.9; R0003210:Supplement Table S6
24	A1	final	percent	27	not stated; other; background:none; R0003210:Supplement Table S7
24	A1	change	percent	11	not stated; other; bmi:more_than_29.0; R0003210:Supplement Table S6
24	A1	final	percent	59	not stated; full analysis; R0003210:Table 1
24	A1	final	percent	15	not stated; full analysis; hba1c:11.0_to_16.5; R0003210:Table 2
24	A1	final	percent	32	not stated; other; background:oral_drugs; R0003210:Supplement Table S7
24	A1	final	percent	13	not stated; full analysis; hba1c:7.6_to_8.7; R0003210:Table 2
24	A1	final	percent		not stated; per protocol; R0003210:Supplement Table S2
24	A1	final	percent	15	not stated; full analysis; hba1c:8.8_to_9.6; R0003210:Table 2
24	A1	change	percent	13	not stated; other; bmi:22.9_to_25.7; R0003210:Supplement Table S6
24	A1	final	percent	16	not stated; full analysis; hba1c:9.7_to_10.9; R0003210:Table 2
24	A1	change	percent	59	not stated; full analysis; R0003210:Results
24	A2	change	percent	15	not stated; other; bmi:25.7_to_29.0; R0003210:Supplement Table S6
24	A2	change	percent	57	not stated; full analysis; R0003210:Results
24	A2	change	percent		not stated; per protocol; R0003210:Results
24	A2	final	percent	57	not stated; full analysis; R0003210:Table 1
24	A2	final	percent		not stated; per protocol; R0003210:Supplement Table S2
24	A2	final	percent	28	not stated; other; background:none; R0003210:Supplement Table S7
24	A2	final	percent	29	not stated; other; background:oral_drugs; R0003210:Supplement Table S7
24	A2	change	percent	15	not stated; other; bmi:22.9_to_25.7; R0003210:Supplement Table S6
24	A2	change	percent	10	not stated; other; bmi:less_than_22.9; R0003210:Supplement Table S6
24	A2	change	percent	17	not stated; other; bmi:more_than_29.0; R0003210:Supplement Table S6
24	A2	final	percent	12	not stated; full analysis; hba1c:11.0_to_16.5; R0003210:Table 2
24	A2	final	percent	14	not stated; full analysis; hba1c:7.6_to_8.7; R0003210:Table 2
24	A2	final	percent	15	not stated; full analysis; hba1c:8.8_to_9.6; R0003210:Table 2
24	A2	final	percent	14	not stated; full analysis; hba1c:9.7_to_10.9; R0003210:Table 2

Body weight change in kilograms (diabetes) (2 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	kg			59	not stated; full analysis; R0003210:Table 1
24	A2	final	kg			57	not stated; full analysis; R0003210:Table 1

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
24	A1	responders	72.3		not stated; per protocol; R0003210:Results
24	A1	responders	61.0	59	not stated; full analysis; R0003210:Results
24	A2	responders	56.5		not stated; per protocol; R0003210:Results
24	A2	responders	47.4	57	not stated; full analysis; R0003210:Results

Level 2 or 3 hypoglycemia (participants) (5 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	1 / 59	not stated; full analysis; R0003210:Table 3
A1	events	4 / 59	not stated; full analysis; R0003210:Table 3
A1	events	5 / 59	not stated; full analysis; R0003210:Results
A2	events	0 / 57	not stated; full analysis; R0003210:Table 3
A2	events	0 / 57	not stated; full analysis; R0003210:Table 3

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	mmHg			59	not stated; full analysis; R0003210:Table 1
24	A2	final	mmHg			57	not stated; full analysis; R0003210:Table 1

Health related quality of life total score (any instrument) (4 lines; O24C)

Week	Arm	Statistic	Estimate	Detail
24	A1	final	points	not stated; other; R0003210:Results
24	A1	final	points	not stated; other; R0003210:Supplement Table S4
24	A2	final	points	not stated; other; R0003210:Results
24	A2	final	points	not stated; other; R0003210:Supplement Table S4

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 59	not stated; full analysis; R0003210:Results
	A2	events				2 / 57	not stated; full analysis; R0003210:Results

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 59	not stated; full analysis; R0003210:Table 3
A1	events	4 / 59	not stated; full analysis; R0003210:Table 3
A2	events	9 / 57	not stated; full analysis; R0003210:Table 3
A2	events	1 / 57	not stated; full analysis; R0003210:Table 3

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	0 / 59	not stated; full analysis; R0003210:Table 3
A1	events	1 / 59	not stated; full analysis; R0003210:Table 3
A2	events	1 / 57	not stated; full analysis; R0003210:Table 3
A2	events	0 / 57	not stated; full analysis; R0003210:Table 3

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 59	not stated; full analysis; R0003210:Table 3
A1	events	1 / 59	not stated; full analysis; R0003210:Table 3
A2	events	1 / 57	not stated; full analysis; R0003210:Table 3
A2	events	1 / 57	not stated; full analysis; R0003210:Table 3

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	1 / 59	not stated; full analysis; nausea; R0003210:Table 3
A1	events	1 / 59	not stated; full analysis; constipation; R0003210:Table 3
A2	events	2 / 57	not stated; full analysis; nausea; R0003210:Table 3