parallel randomized trial

S003036

Type 2 diabetes (adults)S003036

Design

Randomized: 58
Start year: 2022
Treatment: 24 weeks, follow-up 24 weeks
Countries: Japan (4 sites)
Sponsor: (non industry)
Eligibility: age 20 or more; HbA1c 7.0 percent or more; DPP-4 inhibitor for 12 weeks or more

Conduct and analysis

Blinding: open label
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: completers
Missing data: completers only

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Semaglutide 7 mg oral once daily (original tablet) Semaglutide group (switch to oral semaglutide)	other glucose lowering drugs unchanged; DPP-4 inhibitor stopped; lifestyle: none	30	24
A2	Dpp4 inhibitor DPP-4 inhibitors group (continued)	other glucose lowering drugs unchanged; lifestyle: none	28	27

Baseline characteristics

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

Characteristic	Statistic	Semaglutide 7 mg oral once daily (original tablet) A1	Dpp4 inhibitor A2
age	mean (years)	65.6	66.7
age	sd (years)	11.1	9.9
bmi	mean (kg/m2)	26.2	25.0
bmi	sd (kg/m2)	3.0	3.4
diabetes duration	mean (years)	13.7	14.4
diabetes duration	sd (years)	6.0	8.9
egfr	mean (mL/min/1.73 m2)	74.1	69.7
egfr	sd (mL/min/1.73 m2)	21.4	15.5
established cvd	n	1	6
established cvd	percent	4.2	22.2
hba1c	mean (percent)	7.6	7.6
hba1c	sd (percent)	0.4	0.4
metformin use	n	21	21
metformin use	percent	87.5	77.8
other agi use	n	2	5
other agi use	percent	8.3	18.5
other glinide use	n	2	1
other glinide use	percent	8.3	3.7
other male	n	13	15
other male	percent	54.2	55.6
other sulfonylurea use	n	4	6
other sulfonylurea use	percent	16.7	22.2
other tzd use	n	6	1
other tzd use	percent	25.0	3.7
sbp	mean (mmHg)	131.5	130.6
sbp	sd (mmHg)	17.8	14.6
sglt2i use	n	19	17
sglt2i use	percent	79.2	63.0
uacr	median (mg/g)	22.9	25.0
uacr	q1 (mg/g)	10.6	8.6
uacr	q3 (mg/g)	53.9	47.1
weight	mean (kg)	67.9	65.1
weight	sd (kg)	12.7	12.0

Analyses this trial contributes to

Results

43 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	-0.5 percent	0.5	24	not stated; completers; R0017250:Results
24	A1	final	7.1 percent	0.6	24	not stated; completers; R0017250:Table 2
24	A2	change	0.0 percent	0.5	27	not stated; completers; R0017250:Results
24	A2	final	7.5 percent	0.6	27	not stated; completers; R0017250:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
24	A1	change	-2.3 kg	1.8	24	not stated; completers; R0017250:Results
24	A1	final	65.6 kg	12.8	24	not stated; completers; R0017250:Table 2
24	A2	change	-0.4 kg	1.3	27	not stated; completers; R0017250:Results
24	A2	final	64.7 kg	12.0	27	not stated; completers; R0017250:Table 2

HbA1c below 7 percent (2 lines; O03)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	responders	50.0			24	not stated; completers; R0017250:Results
24	A2	responders	14.8			27	not stated; completers; R0017250:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 /	not stated; other; R0017250:Results
	A2	events				0 /	not stated; other; R0017250:Results

Systolic blood pressure change (2 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	130.5 mmHg	20.1		24	not stated; completers; R0017250:Table 2
24	A2	final	131.6 mmHg	18.1		27	not stated; completers; R0017250:Table 2

Acute kidney injury (1 lines; O121)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

All cause mortality (1 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Three point MACE (1 lines; O21)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Four point MACE including unstable angina (1 lines; O21B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Heart failure events (1 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
24	A1	final	26.0 points	6.5		20	not stated; other; R0017250:Table 4
24	A2	final	25.6 points	5.8		20	not stated; other; R0017250:Table 4

Serious adverse events (1 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 /	not stated; other; R0017250:Results
	A2	events				0 /	not stated; other; R0017250:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Vomiting (1 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Diarrhea (1 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Constipation (1 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 /	not stated; other; R0017250:Results
	A2	events				0 /	not stated; other; R0017250:Results

Gallbladder and biliary disease (1 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Acute pancreatitis (1 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Medullary thyroid carcinoma (1 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Thyroid cancer (any) (1 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Diabetic retinopathy complications (1 lines; O33)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Nonarteritic anterior ischemic optic neuropathy (1 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Suicidal ideation or behavior (1 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Death by suicide (1 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Gastroparesis (1 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Intestinal obstruction or ileus (1 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Pancreatic cancer (1 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results

Any cancer (1 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 /	not stated; other; R0017250:Results