parallel randomized trial

NCT01455441

Does the GLP-1 Receptor Agonist (Victoza®) Improve the Metabolic Response to Physical Training in Patients With Type 2 Diabetes?

Design

Randomized: 36
Start year: 2011
Treatment: 16 weeks, follow-up 16 weeks
Countries: Denmark (1 sites)
Sponsor: Novo Nordisk (industry)
Eligibility: age over 18; HbA1c 7 to 11 percent; BMI over 25; diet or metformin; sedentary

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Liraglutide 1.8 mg subcutaneous once daily Exercise plus liraglutide	diet or metformin; supervised exercise three 60 minute sessions weekly; lifestyle: intensive	18	17	17
A2	Placebo Exercise plus placebo	diet or metformin; supervised exercise three 60 minute sessions weekly; lifestyle: intensive	16	16	16

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	Placebo A2
age	mean (years)	56.5	55.6
age	sd (years)	9	12
bmi	mean (kg/m2)	32.5	32.4
bmi	sd (kg/m2)	3.7	5.2
diabetes duration	mean (years)	6.0	3.7
diabetes duration	sd (years)	5.2	3.3
female	n	4	6
female	percent	24	38
hba1c	mean (percent)	8.2	8.0
hba1c	sd (percent)	1.4	1.2
metformin use	n	17	13
sbp	mean (mmHg)	136.2	136.4
sbp	sd (mmHg)	8.9	11.0
weight	mean (kg)	101.0	96.8
weight	sd (kg)	14.5	17.4

30 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
16	A1	change	-2.0 percent	1.2	17	not stated; completers; R0010221:Table 2
16	A1	final	6.2 percent	0.7	17	not stated; completers; R0010221:Table 2
16	A2	change	-0.3 percent	0.9	16	not stated; completers; R0010221:Table 2
16	A2	final	7.7 percent	1.5	16	not stated; completers; R0010221:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	change	-3.4 kg	2.9	17	not stated; completers; R0010221:Table 2
16	A1	final	97.6 kg	14.9	17	not stated; completers; R0010221:Table 2
16	A2	final	95.2 kg	17.7	16	not stated; completers; R0010221:Table 2
16	A2	change	-1.6 kg	3.2	16	not stated; completers; R0010221:Table 2

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
16	A1	responders	77			17	not stated; completers; R0010221:Results
16	A2	responders	25			16	not stated; completers; R0010221:Results

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 17	not stated; completers; R0010221:Results
A1	events	0 / 17	not stated; completers; R0010221:Results
A2	events	0 / 16	not stated; completers; R0010221:Results
A2	events	0 / 16	not stated; completers; R0010221:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
16	A1	final	130.8 mmHg	8.8	17	not stated; completers; R0010221:Table 2
16	A1	change	-5.4 mmHg	7.4	17	not stated; completers; R0010221:Table 2
16	A2	change	-0.6 mmHg	11.1	16	not stated; completers; R0010221:Table 2
16	A2	final	135.8 mmHg	11.6	16	not stated; completers; R0010221:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; completers; R0010221:Results
	A2	events				0 / 16	not stated; completers; R0010221:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; completers; R0010221:Results
	A2	events				0 / 16	not stated; completers; R0010221:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; completers; R0010221:Results
	A2	events				0 / 16	not stated; completers; R0010221:Results

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	24			17	not stated; completers; gastrointestinal side effects; R0010221:Results
	A2	events	6			16	not stated; completers; gastrointestinal side effects; R0010221:Results

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; completers; R0010221:Results
	A2	events				0 / 16	not stated; completers; R0010221:Results

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 17	not stated; completers; R0010221:Results
	A2	events				0 / 16	not stated; completers; R0010221:Results