parallel randomized trial

NCT01425580

Effects on Subclinical Heart Failure in Type 2 Diabetic Subjects on Liraglutide Treatment Versus Glimepiride Both in Combination With Metformin

Design

Randomized: 62
Start year: 2012
Treatment: 18 weeks, follow-up 18 weeks
Countries: Sweden (2 sites)
Sponsor: Thomas Nystrom (mixed)
Eligibility: type 2 diabetes; HbA1c 45 to 97 mmol/mol; subclinical LV dysfunction on echocardiography; BMI 40 or less

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg plus metformin	metformin up to 1 g twice daily; lifestyle: not reported	33	26
A2	Glimepiride Glimepiride 4 mg plus metformin	metformin up to 1 g twice daily; lifestyle: not reported	29	22

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	Glimepiride A2
age	mean (years)	61	63
age	sd (years)	7.6	6.8
bmi	mean (kg/m2)	30.5	29.0
bmi	sd (kg/m2)	4.4	3.2
diabetes duration	median (years)	5	3
diabetes duration	q1 (years)	1	1
diabetes duration	q3 (years)	10	7
egfr	mean (mL/min/1.73 m2)	88.3	87.4
egfr	sd (mL/min/1.73 m2)	15.0	13.1
hba1c	median (percent)	7.1	6.7
hba1c	q1 (percent)	6.7	6.6
hba1c	q3 (percent)	7.6	7.1
lvef	mean (percent)	53.6	53.7
lvef	sd (percent)	11.5	9.2
other male	n	24	21
other male	percent	72.7	72.4
sbp	mean (mmHg)	139	137
sbp	sd (mmHg)	17	12
waist	mean (cm)	109.0	106.3
waist	sd (cm)	13.0	9.7
weight	mean (kg)	91.8	89.0
weight	sd (kg)	15.9	9.9

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
18	A1	change	mmol/mol		31	not stated; other; R0025885:Table 2
18	A1	change	-1.2 percent	-1.4 to -0.8		not stated; other; R0024634:Results
18	A2	change	-0.9 percent	-1.3 to -0.5		not stated; other; R0024634:Results
18	A2	change	mmol/mol		28	not stated; other; R0025885:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
18	A1	change	-3.7 kg	3.5	31	not stated; other; R0021728:Table 2
18	A1	change	kg		31	not stated; other; R0025885:Table 2
18	A2	change	-0.2 kg	4.3	28	not stated; other; R0021728:Table 2
18	A2	change	kg		28	not stated; other; R0025885:Table 2

Level 2 or 3 hypoglycemia (participants) (4 lines; O04)

Arm	Statistic	Events / N	Detail
A1	events	0 / 33	not stated; other; R0025885:Results
A1	events	6 / 33	not stated; other; R0025885:Results
A2	events	0 / 29	not stated; other; R0025885:Results
A2	events	17 / 29	not stated; other; R0025885:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
18	A1	change	mmHg		31	not stated; other; R0025885:Table 2
18	A1	change	-6.6 mmHg	12.7	31	not stated; other; R0021728:Table 2
18	A2	change	-1.9 mmHg	12.0	28	not stated; other; R0021728:Table 2
18	A2	change	mmHg		28	not stated; other; R0025885:Table 2

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 33	not stated; randomized; R0025885:Results
	A2	events				0 / 29	not stated; randomized; R0025885:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 33	not stated; other; R0025885:Results

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 33	not stated; other; R0025885:Results
	A2	events				1 / 29	not stated; other; R0025885:Results

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 33	not stated; other; R0025885:Results
	A2	events				1 / 29	not stated; other; R0025885:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 33	not stated; other; R0025885:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 33	not stated; randomized; nausea; R0025885:Results
	A2	events				0 / 29	not stated; randomized; nausea; R0025885:Results