parallel randomized trial

LIRA-Ramadan™

Efficacy and Safety of Liraglutide Versus Sulphonylurea Both in Combination With Metformin During Ramadan in Subjects With Type 2 Diabetes

Design

Randomized: 343
Start year: 2014
Treatment: 30 weeks, follow-up 31 weeks
Countries: Algeria, Israel, India, Lebanon, Malaysia, South Africa, United Arab Emirates (39 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age 18 to 80; HbA1c 7 to 10 percent; BMI 20 or more; metformin plus sulfonylurea; intent to fast in Ramadan

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg plus metformin	metformin; prior sulfonylurea stopped; lifestyle: not reported	172	171
A2	Sulfonylurea Sulfonylurea plus metformin	metformin; lifestyle: not reported	171	170

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	Sulfonylurea A2
age	mean (years)	54.9	54.0
age	sd (years)	9.27	9.33
asian	n	72	82
asian	percent	42.1	48.2
black	n	2	1
black	percent	1.2	0.6
bmi	mean (kg/m2)	30.2	31.4
bmi	sd (kg/m2)	5.37	5.88
diabetes duration	mean (years)	8.0	7.2
diabetes duration	sd (years)	5.26	4.39
female	n	86	87
female	percent	50.3	51.2
hba1c	mean (percent)	8.3	8.2
hba1c	sd (percent)	0.94	0.91
other race other	n	25	23
other race other	percent	14.6	13.5
sbp	mean (mmHg)	132.9	133.2
sbp	sd (mmHg)	14.39	12.95
weight	mean (kg)	81.0	83.1
weight	sd (kg)	17.1	16.0
white	n	72	64
white	percent	42.1	37.6

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	change	-1.3 percent	1.1		146	not stated; full analysis; registry:outcomes
26	A1 vs A2	md	-0.59 percent		-0.79 to -0.38		not stated; full analysis; R0025756:Results
26	A2	change	-0.7 percent	0.9		156	not stated; full analysis; registry:outcomes
30	A1 vs A2	md	-0.60 percent		-0.82 to -0.38		not stated; full analysis; R0025756:Results

Body weight change in kilograms (diabetes) (4 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1 vs A2	md	-3.94 kg		-4.54 to -3.33		not stated; full analysis; R0025756:Results
26	A1	change	-5.40 kg	0.2205		165	not stated; full analysis; registry:outcomes
26	A2	change	-1.46 kg	0.2139		168	not stated; full analysis; registry:outcomes
30	A1 vs A2	md	-3.95 kg		-4.57 to -3.33		not stated; full analysis; R0025756:Results

HbA1c below 7 percent (8 lines; O03)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	57.1			not stated; modified itt; R0025756:Figure 3
26	A1 vs A2	or	3.71	2.18 to 6.30		not stated; modified itt; R0025756:Figure 3
26	A2	responders	26.4			not stated; modified itt; R0025756:Figure 3
30	A1	responders	50.7			not stated; modified itt; R0025756:Figure 3
30	A1	responders	51.0		171	not stated; full analysis; registry:outcomes
30	A1 vs A2	or	2.98	1.78 to 4.97		not stated; modified itt; R0025756:Figure 3
30	A2	responders	25.7			not stated; modified itt; R0025756:Figure 3
30	A2	responders	29.9		169	not stated; full analysis; registry:outcomes

Level 2 or 3 hypoglycemia (participants) (10 lines; O04)

Arm	Statistic	Estimate	Events / N	Detail
A1	events		3 / 152	while on treatment; safety; R0025756:Results
A1	events		3 / 152	while on treatment; safety; R0025756:Results
A1	events		5 / 171	while on treatment; safety; R0025756:Results
A1	events		0 / 171	while on treatment; safety; R0025756:Results
A1	events		0 / 152	while on treatment; safety; R0025756:Results
A2	events		0 / 170	while on treatment; safety; R0025756:Results
A2	events	4.3	163	while on treatment; safety; R0025756:Results
A2	events		16 / 170	while on treatment; safety; R0025756:Results
A2	events		0 / 163	while on treatment; safety; R0025756:Results
A2	events		18 / 163	while on treatment; safety; R0025756:Results

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

Arm	Statistic	Estimate	95% CI	Detail
A1 vs A2	rate ratio	0.2	0.1 to 0.5	while on treatment; safety; R0025756:Results
A1 vs A2	rate ratio	0.12	0.03 to 0.42	while on treatment; safety; R0025756:Results
A1 vs A2	rate ratio	0.17	0.08 to 0.36	while on treatment; safety; R0025756:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				0 / 170	not stated; safety; R0025756:Supplement Table S2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				5 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				2 / 170	not stated; safety; R0025756:Supplement Table S2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				0 / 170	not stated; safety; R0025756:Supplement Table S2

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				57 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				0 / 170	not stated; safety; R0025756:Supplement Table S2

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				35 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				1 / 170	not stated; safety; R0025756:Supplement Table S2

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				37 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				6 / 170	not stated; safety; R0025756:Supplement Table S2

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				1 / 170	not stated; safety; R0025756:Supplement Table S2

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				11 / 171	not stated; safety; R0025756:Supplement Table S2
	A2	events				0 / 170	not stated; safety; R0025756:Supplement Table S2

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 171	not stated; safety; R0025756:Results
	A2	events				0 / 170	not stated; safety; R0025756:Results