parallel randomized trial

HISTORI

Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes

Design

Randomized: 154
Start year: 2022
Treatment: 30 weeks, follow-up 30 weeks
Countries: Denmark (2 sites)
Sponsor: Jan Frystyk (mixed)
Eligibility: age 18 to 60; schizophrenia spectrum on SGA; BMI 27 or more; HbA1c 39 to 47 mmol/mol; no diabetes

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide up to 1.0 mg once weekly	second generation antipsychotics; lifestyle: not reported	77
A2	Placebo Placebo	second generation antipsychotics; lifestyle: not reported	77

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

Characteristic	Statistic	Semaglutide 1.0 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	39.1	37.6
age	sd (years)	10.9	10.6
antipsychotic: aripiprazole	n	23	33
antipsychotic: aripiprazole	percent	30	43
antipsychotic: clozapine	n	22	19
antipsychotic: clozapine	percent	29	25
antipsychotic: olanzapine	n	13	9
antipsychotic: olanzapine	percent	17	12
antipsychotic: other	n	8	13
antipsychotic: other	percent	10	17
antipsychotic: paliperidone	n	5	4
antipsychotic: paliperidone	percent	6	5
antipsychotic: quetiapine	n	34	36
antipsychotic: quetiapine	percent	44	47
antipsychotic: risperidone	n	2	8
antipsychotic: risperidone	percent	3	11
antipsychotic: ziprasidone	n	3	3
antipsychotic: ziprasidone	percent	4	4
bmi	mean (kg/m2)	40.66	40.16
bmi	sd (kg/m2)	8.14	8.47
female	n	35	52
female	percent	45	68
hba1c	mean (mmol/mol)	40.94	41.5
hba1c	sd (mmol/mol)	2.65	2.40
metformin use	n	4	7
metformin use	percent	5	9
sbp	mean (mmHg)	130.04	129.66
sbp	sd (mmHg)	12.98	12.55
waist	mean (cm)	120.78	116.86
waist	sd (cm)	15.54	14.22
weight	mean (kg)	122.28	119.66
weight	sd (kg)	25.92	27.68

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

Systolic blood pressure change (6 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
30	A1	change	-2.91 mmHg	-5.75 to -0.08	74	not stated; modified itt; R0007772:Supplement Table 2
30	A1	change	-1.61 mmHg	-3.57 to 0.35		not stated; modified itt; R0014539:Table 2
30	A1 vs A2	md	-2.26 mmHg	-6.42 to 1.91		not stated; modified itt; R0007772:Supplement Table 2
30	A1 vs A2	md	-1.38 mmHg	-5.03 to 2.26		not stated; modified itt; R0014539:Table 2
30	A2	change	-0.66 mmHg	-3.7 to 2.38	68	not stated; modified itt; R0007772:Supplement Table 2
30	A2	change	-0.23 mmHg	-3.24 to 2.79		not stated; modified itt; R0014539:Table 2

Progression to type 2 diabetes (1 lines; O14)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 77	not stated; randomized; R0014539:Supplementary Figure S1

All cause mortality (1 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				1 / 77	not stated; randomized; R0007772:Figure 2