parallel randomized trial

S003012

Design

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	semaglutide Test product (Intas semaglutide)	metformin; lifestyle: standard	112	108
A2	semaglutide Reference product (Novo Nordisk semaglutide)	metformin; lifestyle: standard	111	109

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

Characteristic	Statistic	Test product (Intas semaglutide) A1	Reference product (Novo Nordisk semaglutide) A2
age	mean (years)	49	48
age	sd (years)	10.2	10.4
bmi	mean (kg/m2)	30.8	30.5
bmi	sd (kg/m2)	5.6	5.1
diabetes duration	mean (months)	44	42
female	n	46	58
female	percent	42.6	53.2
hba1c	mean (percent)	8.4	8.4
hba1c	sd (percent)	1.0	0.9
weight	mean (kg)	80.7	79.1
weight	sd (kg)	15.7	16.7

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

HbA1c change (8 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
24	A1	change	-1.50 percent		108	not stated; modified itt; R0014460:Table 2
24	A1	change	-1.51 percent		108	not stated; modified itt; R0014460:Table 2
24	A1	change	-1.54 percent		105	not stated; per protocol; R0014460:Supplement Table 1
24	A1 vs A2	md	0.16 percent	-0.16 to 0.47		not stated; modified itt; R0014460:Table 2
24	A1 vs A2	md	0.15 percent	-0.16 to 0.46		not stated; per protocol; R0014460:Supplement Table 1
24	A2	change	-1.65 percent		109	not stated; modified itt; R0014460:Table 2
24	A2	change	-1.63 percent		109	not stated; modified itt; R0014460:Table 2
24	A2	change	-1.69 percent		100	not stated; per protocol; R0014460:Supplement Table 1

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	change	-6.0 kg	3.3			not stated; modified itt; R0014460:Results
24	A2	change	-5.8 kg	3.7			not stated; modified itt; R0014460:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				6 / 112	not stated; safety; R0014460:Table 3
	A2	events				7 / 111	not stated; safety; R0014460:Table 3

Weight loss of 5 percent or more (2 lines; O11A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	69.4			108	not stated; modified itt; R0014460:Results
24	A2	responders	66.1			109	not stated; modified itt; R0014460:Results

Weight loss of 10 percent or more (2 lines; O11B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	19.4			108	not stated; modified itt; R0014460:Results
24	A2	responders	15.6			109	not stated; modified itt; R0014460:Results

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 111	not stated; safety; R0014460:Table 3

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 112	not stated; safety; R0014460:Table 3
	A2	events				0 / 111	not stated; safety; R0014460:Table 3

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 112	not stated; safety; R0014460:Table 3
	A2	events				0 / 111	not stated; safety; R0014460:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 112	not stated; safety; R0014460:Table 3
	A2	events				0 / 111	not stated; safety; R0014460:Table 3

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 112	not stated; safety; R0014460:Table 3
	A2	events				0 / 111	not stated; safety; R0014460:Table 3

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 112	not stated; safety; R0014460:Table 3
	A2	events				9 / 111	not stated; safety; R0014460:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 112	not stated; safety; R0014460:Table 3
	A2	events				10 / 111	not stated; safety; R0014460:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 112	not stated; safety; R0014460:Table 3
	A2	events				10 / 111	not stated; safety; R0014460:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 112	not stated; safety; R0014460:Table 3
	A2	events				0 / 111	not stated; safety; R0014460:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 112	not stated; safety; R0014460:Table 3
	A2	events				0 / 111	not stated; safety; R0014460:Table 3

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 112	not stated; safety; R0014460:Table 3
	A2	events				0 / 111	not stated; safety; R0014460:Table 3