parallel randomized trial

NCT02008682

The Efficacy and Safety of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes.(LIRA-DPP-4 CHINA™)

Type 2 diabetes (adults)NCT02008682S000650

Design

Randomized: 368
Start year: 2013
Treatment: 26 weeks, follow-up 27 weeks
Countries: China (25 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: Chinese adults 18 to 80; HbA1c 7.0 to 10.0 on metformin; BMI 45 or lower

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	metformin; lifestyle: not reported	184	183
A2	Sitagliptin Sitagliptin 100 mg	metformin; lifestyle: not reported	184	184

Baseline characteristics

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

Characteristic	Statistic	Liraglutide 1.8 mg subcutaneous once daily A1	Sitagliptin A2
age	mean (years)	51.7	51.4
age	sd (years)	10.7	11.0
bmi	mean (kg/m2)	27.3	27.2
bmi	sd (kg/m2)	3.4	4.0
diabetes duration	mean (years)	5.3	5.2
diabetes duration	sd (years)	4.4	5.4
female	n	81	67
female	percent	44.3	36.4
hba1c	mean (percent)	8.14	8.11
hba1c	sd (percent)	0.83	0.78
sbp	mean (mmHg)	129.25	128.30
waist	mean (cm)	95.37	95.55
weight	mean (kg)	76.2	75.8
weight	sd (kg)	13.6	15.1

Analyses this trial contributes to

Results

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

HbA1c change (7 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	-0.78 percent		-1.02 to -0.55		not stated; full analysis; bmi:<28; R0025836:Supplement Table S2
26	A1 vs A2	md	-0.81 percent		-1.08 to -0.53		not stated; full analysis; hba1c:>8; R0025836:Supplement Table S2
26	A1 vs A2	md	-0.67 percent		-0.86 to -0.48		not stated; full analysis; R0025836:Results
26	A1	change	-1.666 percent	0.9982		162	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-0.49 percent		-0.80 to -0.17		not stated; full analysis; bmi:>=28; R0025836:Supplement Table S2
26	A1 vs A2	md	-0.54 percent		-0.81 to -0.28		not stated; full analysis; hba1c:<=8; R0025836:Supplement Table S2
26	A2	change	-0.969 percent	0.9742		175	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	95% CI	Detail
26	A1 vs A2	md	-1.86 kg	-2.96 to -0.77	not stated; full analysis; bmi:>=28; R0025836:Supplement Table S2
26	A1 vs A2	md	-2.10 kg	-2.76 to -1.43	not stated; full analysis; R0025836:Results
26	A1 vs A2	md	-2.22 kg	-3.05 to -1.38	not stated; full analysis; bmi:<28; R0025836:Supplement Table S2
26	A1 vs A2	md	-2.23 kg	-3.15 to -1.30	not stated; full analysis; hba1c:<=8; R0025836:Supplement Table S2
26	A1 vs A2	md	-1.95 kg	-2.92 to -0.97	not stated; full analysis; hba1c:>8; R0025836:Supplement Table S2

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	76.5		162	not stated; full analysis; registry:outcomes
26	A1 vs A2	or	3.65	2.18 to 6.12		not stated; full analysis; R0025836:Figure 3
26	A2	responders	52.6		175	not stated; full analysis; registry:outcomes

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 183	not stated; safety; R0025836:Results
	A2	events				1 / 184	not stated; safety; R0025836:Results

Systolic blood pressure change (1 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	-1.55 mmHg		-3.85 to 0.74		not stated; full analysis; R0025836:Supplement Table S1

Weight loss of 5 percent or more (3 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Detail
26	A1 vs A2	or	4.50	2.68 to 7.54	not stated; full analysis; R0025836:Figure 3
26	A1	responders	43.5		not stated; full analysis; R0025836:Figure 3
26	A2	responders	15.5		not stated; full analysis; R0025836:Figure 3

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 183	not stated; safety; R0025836:Results
	A2	events				0 / 184	not stated; safety; R0025836:Results

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	0.70 points				not stated; full analysis; R0025836:Results
26	A2	change	0.76 points				not stated; full analysis; R0025836:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 183	not stated; safety; R0025836:Table 2
	A2	events				6 / 184	not stated; safety; R0025836:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				12 / 183	not stated; safety; R0025836:Figure 1
	A2	events				3 / 184	not stated; safety; R0025836:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				27 / 183	not stated; safety; R0025836:Table 2
	A2	events				1 / 184	not stated; safety; R0025836:Table 2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				15 / 183	not stated; safety; R0025836:Table 2
	A2	events				4 / 184	not stated; safety; R0025836:Table 2

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 183	not stated; safety; R0025836:Results
	A2	events				0 / 184	not stated; safety; R0025836:Results

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 183	not stated; safety; R0025836:Table 2
	A2	events				1 / 184	not stated; safety; R0025836:Table 2

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 183	not stated; safety; R0025836:Results
	A2	events				2 / 184	not stated; safety; R0025836:Results