parallel randomized trial

S002993

Design

Randomized: 314
Start year
Treatment: 24 weeks, follow-up 26 weeks
Countries: India (35 sites)
Sponsor: Sun Pharmaceutical Industries Limited (industry)
Eligibility: age 18 to 65; HbA1c 7.0 to 10.5 percent; stable metformin 1500 mg/day or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	semaglutide Test semaglutide injection	metformin at least 1500 mg/day or maximum tolerated dose; lifestyle: standard	157	142	143
A2	semaglutide Reference semaglutide injection (Ozempic)	metformin at least 1500 mg/day or maximum tolerated dose; lifestyle: standard	157	146	147

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

Characteristic	Statistic	Test semaglutide injection A1	Reference semaglutide injection (Ozempic) A2
age	mean (years)	48.96	48.06
age	sd (years)	8.92	9.01
bmi	mean (kg/m2)	27.37	27.41
bmi	sd (kg/m2)	4.33	4.34
diabetes duration	median (months)	13.93	13.96
diabetes duration	q1 (months)	5.91	5.98
diabetes duration	q3 (months)	37.98	37.94
female	n	64	60
female	percent	40.8	38.2
hba1c	mean (percent)	8.62	8.61
hba1c	sd (percent)	0.85	0.92
sbp	mean (mmHg)	124.5	123.9
sbp	sd (mmHg)	6.24	6.07
weight	mean (kg)	71.70	73.24
weight	sd (kg)	12.10	12.36

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

HbA1c change (13 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	change	-1.84 percent			142	not stated; per protocol; R0010918:Figure 3A
20	A2	change	-1.78 percent			146	not stated; per protocol; R0010918:Figure 3A
24	A1	change	-2.04 percent			142	not stated; per protocol; R0010918:Results
24	A1	change	-2 percent	0.06	-2.13 to -1.88	152	not stated; randomized; R0010918:Supplement Appendix S3
24	A1	change	-2.00 percent	0.85		152	not stated; randomized; R0010918:Supplement Appendix S3
24	A1	change	-1.97 percent	0.06	-2.1 to -1.85	157	not stated; randomized; R0010918:Supplement Appendix S2
24	A1 vs A2	md	-0.09 percent		-0.26 to 0.09		not stated; per protocol; R0010918:Results
24	A1 vs A2	md	-0.04 percent		-0.21 to 0.14		not stated; randomized; R0010918:Supplement Appendix S3
24	A1 vs A2	md	-0.04 percent		-0.22 to 0.14		not stated; randomized; R0010918:Supplement Appendix S2
24	A2	change	-1.95 percent			146	not stated; per protocol; R0010918:Results
24	A2	change	-1.97 percent	0.06	-2.09 to -1.84	150	not stated; randomized; R0010918:Supplement Appendix S3
24	A2	change	-1.95 percent	0.90		150	not stated; randomized; R0010918:Supplement Appendix S3
24	A2	change	-1.93 percent	0.07	-2.06 to -1.81	157	not stated; randomized; R0010918:Supplement Appendix S2

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

Week	Arm	Statistic	Estimate	Events / N	Detail
20	A1	change	-5.21 kg	142	not stated; per protocol; R0010918:Figure 4A
20	A2	change	-5.3 kg	146	not stated; per protocol; R0010918:Figure 4A
24	A1	change	-6.17 kg	142	not stated; per protocol; R0010918:Results
24	A2	change	-6.17 kg	146	not stated; per protocol; R0010918:Results

HbA1c below 7 percent (4 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
20	A1	responders	62.0	142	not stated; per protocol; R0010918:Results
20	A2	responders	61.0	146	not stated; per protocol; R0010918:Results
24	A1	responders	74.6	142	not stated; per protocol; R0010918:Results
24	A2	responders	74.0	146	not stated; per protocol; R0010918:Results

Level 2 or 3 hypoglycemia (episode rate) (3 lines; O04B)

Arm	Statistic	Events / N	Detail
A1	rate	157	not stated; safety; R0010918:Results
A2	rate	157	not stated; safety; R0010918:Results
A2	rate	157	not stated; safety; R0010918:Results

Systolic blood pressure change (4 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
20	A1	change	-1.47 mmHg	7.13	142	not stated; per protocol; R0010918:Supplement Appendix S4
20	A2	change	-0.92 mmHg	7.49	146	not stated; per protocol; R0010918:Supplement Appendix S4
24	A1	change	-1.46 mmHg	7.16	142	not stated; per protocol; R0010918:Supplement Appendix S4
24	A2	change	-1.08 mmHg	6.76	146	not stated; per protocol; R0010918:Supplement Appendix S4

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	percent change	-8.61 percent				not stated; per protocol; R0010918:Results
24	A2	percent change	-8.39 percent				not stated; per protocol; R0010918:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Results
	A2	events				0 / 157	not stated; safety; R0010918:Results

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Results
	A2	events				0 / 157	not stated; safety; R0010918:Results

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 157	not stated; safety; R0010918:Results
	A2	events				0 / 157	not stated; safety; R0010918:Results

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	3 / 157	not stated; safety; R0010918:Results
A1	events	2 / 157	not stated; randomized; R0010918:Figure 2
A2	events	0 / 157	not stated; randomized; R0010918:Figure 2
A2	events	0 / 157	not stated; safety; R0010918:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Results
	A2	events				0 / 157	not stated; safety; R0010918:Results

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Discussion
	A2	events				0 / 157	not stated; safety; R0010918:Discussion

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Results
	A2	events				0 / 157	not stated; safety; R0010918:Results

Diabetic retinopathy complications (2 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Results
	A2	events				0 / 157	not stated; safety; R0010918:Results

Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Discussion
	A2	events				0 / 157	not stated; safety; R0010918:Discussion

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 157	not stated; safety; R0010918:Results
	A2	events				0 / 157	not stated; safety; R0010918:Results