parallel randomized trial

S002985

Design

Randomized: 267
Start year: 2025
Treatment: 24 weeks, follow-up 28 weeks
Countries: India (21 sites)
Sponsor: Sun Pharmaceutical Industries Limited (industry)
Eligibility: age 18 to 65, BMI 30 or more or 27 with comorbidity including T2D, T2D HbA1c 7 to 10 percent

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 2.4 mg subcutaneous once weekly Test semaglutide 2.4 mg (Sun Pharma)	sulfonylurea dose could be halved in T2D; lifestyle: standard	177	165
A2	Semaglutide 2.4 mg subcutaneous once weekly Reference semaglutide 2.4 mg (Wegovy)	sulfonylurea dose could be halved in T2D; lifestyle: standard	90	80

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

Characteristic	Statistic	Semaglutide 2.4 mg subcutaneous once weekly A1	Semaglutide 2.4 mg subcutaneous once weekly A2	Whole trial ALL
age	mean (years)	40.84	42.57
age	sd (years)	10.04	10.31
bmi	mean (kg/m2)	34.56	35.14
bmi	sd (kg/m2)	4.19	4.67
diabetes duration diabetes:t2d	median (months)	38.5	32.2
diabetes duration diabetes:t2d	q1 (months)	8.3	8.2
diabetes duration diabetes:t2d	q3 (months)	37.3	37.4
female	n	85	49
female	percent	48.0	54.4
hba1c diabetes:none	mean (percent)	5.51	5.50
hba1c diabetes:none	sd (percent)	0.47	0.43
hba1c diabetes:t2d	mean (percent)	8.43	8.36
hba1c diabetes:t2d	sd (percent)	0.75	0.71
other glimepiride monotherapy diabetes:t2d	n			8
other metformin glimepiride diabetes:t2d	n			5
other metformin monotherapy diabetes:t2d	n			58
other t2d	n			71
waist	mean (cm)	112.6	113.1
waist	sd (cm)	15.82	15.23
weight	mean (kg)	93.82	92.96
weight	sd (kg)	14.39	14.37

41 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
24	A1	change	-1.97 percent	1.03	45	not stated; other; diabetes:t2d; R0010020:Supplement Appendix 1
24	A1	final	6.46 percent	0.75	45	not stated; other; diabetes:t2d; R0010020:Supplement Appendix 1
24	A2	change	-1.99 percent	0.92	23	not stated; other; diabetes:t2d; R0010020:Supplement Appendix 1
24	A2	final	6.37 percent	0.85	23	not stated; other; diabetes:t2d; R0010020:Supplement Appendix 1

Percent body weight change (8 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
20	A1	percent change	-11.30 percent			165	not stated; per protocol; R0010020:Figure 3
20	A2	percent change	-11.50 percent			80	not stated; per protocol; R0010020:Figure 3
24	A1	percent change	-13.8 percent	4.28		165	not stated; per protocol; R0010020:Results
24	A1	percent change	-13.6 percent	4.45		177	not stated; randomized; R0010020:Results
24	A1 vs A2	md	0.26 percent		-0.86 to 1.39		not stated; per protocol; R0010020:Results
24	A1 vs A2	md	0.19 percent		-0.95 to 1.33		not stated; randomized; R0010020:Results
24	A2	percent change	-14.1 percent	4.11		80	not stated; per protocol; R0010020:Results
24	A2	percent change	-13.7 percent	4.59		90	not stated; randomized; R0010020:Results

Weight loss of 5 percent or more (4 lines; O11A)

Week	Arm	Statistic	Estimate	Events / N	Detail
20	A1	responders	95.80	165	not stated; per protocol; R0010020:Figure 3
20	A2	responders	96.30	80	not stated; per protocol; R0010020:Figure 3
24	A1	responders	96.40	165	not stated; per protocol; R0010020:Figure 3
24	A2	responders	98.80	80	not stated; per protocol; R0010020:Figure 3

Weight loss of 10 percent or more (4 lines; O11B)

Week	Arm	Statistic	Estimate	Events / N	Detail
20	A1	responders	63.60	165	not stated; per protocol; R0010020:Figure 3
20	A2	responders	63.80	80	not stated; per protocol; R0010020:Figure 3
24	A1	responders	80.60	165	not stated; per protocol; R0010020:Figure 3
24	A2	responders	80.00	80	not stated; per protocol; R0010020:Figure 3

Health related quality of life total score (any instrument) (4 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
20	A1	change	19.35 points	18.96	165	not stated; other; R0010020:Table 2
20	A2	change	17.60 points	20.51	80	not stated; other; R0010020:Table 2
24	A1	change	23.73 points	18.89	165	not stated; other; R0010020:Table 2
24	A2	change	22.51 points	21.10	80	not stated; other; R0010020:Table 2

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 177	not stated; safety; R0010020:Supplement Appendix 3
A1	events	2 / 177	not stated; safety; R0010020:Supplement Appendix 3
A2	events	2 / 90	not stated; safety; R0010020:Supplement Appendix 3
A2	events	2 / 90	not stated; safety; R0010020:Supplement Appendix 3

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 177	not stated; safety; R0010020:Supplement Appendix 3
A2	events	4 / 90	not stated; safety; R0010020:Supplement Appendix 3
A2	events	2 / 90	not stated; randomized; R0010020:Figure 2

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				29 / 177	not stated; safety; R0010020:Supplement Appendix 3
	A2	events				19 / 90	not stated; safety; R0010020:Supplement Appendix 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				38 / 177	not stated; safety; R0010020:Supplement Appendix 3
	A2	events				20 / 90	not stated; safety; R0010020:Supplement Appendix 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				31 / 177	not stated; safety; R0010020:Supplement Appendix 3
	A2	events				27 / 90	not stated; safety; R0010020:Supplement Appendix 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				9 / 177	not stated; safety; R0010020:Supplement Appendix 3
	A2	events				9 / 90	not stated; safety; R0010020:Supplement Appendix 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 177	not stated; safety; R0010020:Supplement Appendix 3
	A2	events				1 / 90	not stated; safety; R0010020:Supplement Appendix 3