parallel randomized trial

S003035

Design

Randomized: 13
Start year
Treatment: 12 weeks, follow-up 12 weeks
Countries: Spain (1 sites)
Sponsor: Fundacion de Investigacion Sanitaria La Fe (non industry)
Eligibility: age 18 to 80; type 2 diabetes hospitalized with acute coronary syndrome; glucose below 400 mg/dL; insulin below 0.7 U/kg/day

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.2 mg subcutaneous once daily Liraglutide	correction insulin aspart as needed; lifestyle: standard	5	5
A2	Insulin glargine Insulin glargine	correction insulin aspart as needed; lifestyle: standard	8	8

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

Characteristic	Statistic	Liraglutide 1.2 mg subcutaneous once daily A1	Insulin glargine A2	Whole trial ALL
age	mean (years)	53.8	65.2
bmi	mean (kg/m2)	29.46	27.9
diabetes duration	mean (years)	9.2	15
hba1c	mean (percent)	8.48	7.8
other male	percent			92
waist	mean (cm)	103.6	109
weight	mean (kg)	88.8	81

11 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	Events / N	Detail
12	A1	change	-1.51 percent			not stated; other; R0018688:Results
12	A1	final	6.9 percent	0.85	5	not stated; other; R0018688:Table 4
12	A2	change	-1.271 percent			not stated; other; R0018688:Results
12	A2	final	6.49 percent	0.92	8	not stated; other; R0018688:Table 4

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	final	87.5 kg			5	not stated; other; R0018688:Table 1
12	A2	final	83.8 kg			8	not stated; other; R0018688:Table 1

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 5	not stated; other; R0018688:Results
	A2	events				0 / 8	not stated; other; R0018688:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 5	not stated; other; R0018688:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 5	not stated; other; R0018688:Results
	A2	events				0 / 8	not stated; other; R0018688:Results