Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Tirzepatide 5 mg subcutaneous once weekly Tirzepatide 5 mg once weekly	insulin by pump or multiple daily injections; lifestyle: none	12	12	11
A2	Placebo Placebo	insulin by pump or multiple daily injections; lifestyle: none	12	12	11

Baseline characteristics

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

Characteristic	Statistic	Tirzepatide 5 mg subcutaneous once weekly A1	Placebo A2
age	mean (years)	40.5	41.7
age	sd (years)	10.9	10.2
bmi: 30 to 34.9	n	7	8
bmi: 30 to 34.9	percent	58.3	66.7
bmi: 35 to 39.9	n	4	4
bmi: 35 to 39.9	percent	33.3	33.3
bmi: 40 or more	n	1	0
bmi: 40 or more	percent	8.3	0.0
bmi	mean (kg/m2)	34.2	33.2
bmi	sd (kg/m2)	3.4	3.0
diabetes duration	mean (years)	17.1	29.4
diabetes duration	sd (years)	10.9	11.1
female	n	5	5
female	percent	42	42
hba1c	mean (percent)	7.3	7.2
hba1c	sd (percent)	1.3	1.2
insulin dose	mean (U/kg/day)	0.7	0.7
insulin dose	sd (U/kg/day)	0.2	0.4
metformin use	n	2	2
metformin use	percent	16.7	16.7
sbp	mean (mmHg)	131	133
sbp	sd (mmHg)	15	11
weight	mean (kg)	104.8	97.7
weight	sd (kg)	14.6	12.9
white	n	11	11
white	percent	91.7	91.7

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
12	A1	change	-0.5 percent	-0.8 to -0.2	11	not stated; modified itt; R0014500:Table 2
12	A1 vs A2	md	-0.4 percent	-0.7 to 0.0		not stated; modified itt; R0014500:Table 2
12	A2	change	-0.2 percent	-0.5 to 0.1	11	not stated; modified itt; R0014500:Table 2

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; R0014500:Results
	A2	events				0 / 12	not stated; safety; R0014500:Results

Total daily insulin dose change (2 lines; O06)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	-0.19 U/kg/day		-0.27 to -0.10	11	not stated; modified itt; R0014500:Table 2
12	A2	change	0 U/kg/day		-0.04 to 0.05	11	not stated; modified itt; R0014500:Table 2

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; R0014500:Results
	A2	events				0 / 12	not stated; safety; R0014500:Results

Discontinuation due to adverse events (1 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 12	not stated; randomized; R0014500:Results

Nausea (1 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events	50			12	not stated; randomized; R0014500:Results

Discontinuation due to gastrointestinal adverse events (1 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; R0014500:Conclusions

Diabetic ketoacidosis (2 lines; O30)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; R0014500:Results
	A2	events				0 / 12	not stated; safety; R0014500:Results

Severe hypoglycemia (type 1 diabetes) (2 lines; O31)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 12	not stated; safety; R0014500:Results
	A2	events				0 / 12	not stated; safety; R0014500:Results