parallel randomized trial

EXISECRET

Effects of 12 Weeks of Endurance Exercise Training Alone or in Combination With Glucagon Like Peptide 1 Receptor Agonist (GLP-1 RA) Treatment on Insulin Secretory Capacity in Type 2 Diabetes

Type 2 diabetes (adults)NCT04383197S002112

Design

Randomized: 31
Start year: 2019
Treatment: 32 weeks, follow-up 32 weeks
Countries: Denmark (1 sites)
Sponsor: University of Copenhagen (non industry)
Eligibility: age 40 to 70, BMI above 28, HbA1c 48 mmol/mol or more if untreated, preserved beta cell function, no insulin

Conduct and analysis

Blinding: open label
Sequence generation: other adequate
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: mixed effects model

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Lifestyle intervention (randomized arm) Aerobic training	lifestyle: intensive	15	15
A2	semaglutide Semaglutide then semaglutide plus aerobic training	lifestyle: intensive	16	16

Baseline characteristics

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

Characteristic	Statistic	Lifestyle intervention (randomized arm) A1	Semaglutide then semaglutide plus aerobic training A2
age	mean (years)	56	59
age	sd (years)	5.7	6.2
bmi	mean (kg/m2)	34.6	34.8
bmi	sd (kg/m2)	5.4	4.8
diabetes duration	mean (years)	4.2	5.2
diabetes duration	sd (years)	4	3
female	n	2	2
hba1c	mean (percent)	7.4	8.1
hba1c	sd (percent)	1.1	1.3
sbp	mean (mmHg)	129	135
sbp	sd (mmHg)	16	13
weight	mean (kg)	110.3	111.7
weight	sd (kg)	21.1	22.3

Results

14 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
12	A1	change	-0.4 percent	-0.8 to -0.04	15	not stated; randomized; R0020754:Table 1
12	A2 vs A1	md	-0.1 percent	-0.5 to 0.4		not stated; randomized; R0020754:Table 1
20	A2	change	-1.4 percent	-2.2 to -0.6	12	not stated; other; R0020754:Table 1
32	A2	change	-0.5 percent	-0.9 to -0.1	16	not stated; randomized; R0020754:Table 1

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

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	change	-1.2 kg	-3.3 to 0.9	15	not stated; randomized; R0020754:Table 1
12	A2 vs A1	md	-1.0 kg	-3.5 to 1.5		not stated; randomized; R0020754:Table 1
20	A2	change	-6.7 kg	-9.9 to -3.5	12	not stated; other; R0020754:Table 1
32	A2	change	-2.2 kg	-4.2 to -0.2	16	not stated; randomized; R0020754:Table 1

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	change	-3 mmHg	-8 to 2	15	not stated; randomized; R0020754:Table 1
12	A2 vs A1	md	-2 mmHg	-8 to 3.5		not stated; randomized; R0020754:Table 1
20	A2	change	-4 mmHg	-9 to 0	12	not stated; other; R0020754:Table 1
32	A2	change	-5 mmHg	-10 to -1	16	not stated; randomized; R0020754: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 / 15	not stated; randomized; R0020754:Methods
	A2	events				0 / 16	not stated; randomized; R0020754:Methods