parallel randomized trial

NCT03951753

The Effect of Tirzepatide on α and β Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus

Design

Randomized: 117
Start year: 2019
Treatment: 28 weeks, follow-up 32 weeks
Countries: Germany (2 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 20 to 74; BMI 25 to 45; metformin with or without one other oral agent

Arm	Treatment	Background	Randomized	Analyzed
A1	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	metformin; lifestyle: not reported	45	45
A2	Semaglutide 1.0 mg subcutaneous once weekly Semaglutide 1 mg	metformin; lifestyle: not reported	44	44
A3	Placebo Placebo	metformin; lifestyle: not reported	28	28

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

Characteristic	Statistic	Tirzepatide 15 mg subcutaneous once weekly A1	Semaglutide 1.0 mg subcutaneous once weekly A2	Placebo A3
age: 18 to 65	n	31	20	18
age: 65 or older	n	14	24	10
age	mean (years)	61.1	63.7	60.4
age	sd (years)	7.1	5.9	7.6
asian	n	0	0	0
black	n	1	0	0
black	percent	2.2
bmi	mean (kg/m2)	31.3	30.8	32.2
bmi	sd (kg/m2)	5.0	3.8	4.0
diabetes duration	mean (years)	10.2	12.7	11.0
diabetes duration	sd (years)	5.8	6.1	6.8
female	n	14	10	7
hba1c	mean (percent)	7.8	7.7	7.9
hba1c	sd (percent)	0.7	0.6	0.5
hispanic	n	0	0	0
other race american indian alaska native	n	0	0	0
other race multiple	n	0	0	0
other race native hawaiian pacific islander	n	0	0	0
waist	mean (cm)	113.5	109.7	109.2
waist	sd (cm)	8.9	9.2	12.0
weight	mean (kg)	94.2	92.7	98.7
weight	sd (kg)	14.0	14.0	14.6
white	n	44	44	28
white	percent	97.8	100.0	100.0

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

HbA1c change (9 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	change	-2.05 percent				not stated; modified itt; R0004430:Table 1
28	A1	change	2.05 percent	0.079		41	not stated; modified itt; registry:outcomes
28	A1 vs A2	md	-0.41 percent		-0.63 to -0.19		not stated; modified itt; registry:outcomes
28	A1 vs A3	md	-2.33 percent		-2.58 to -2.08		not stated; modified itt; registry:outcomes
28	A2	change	-1.64 percent				not stated; modified itt; R0004430:Table 1
28	A2	change	-1.64 percent	0.078		43	not stated; modified itt; registry:outcomes
28	A2 vs A3	md	-1.93 percent		-2.18 to -1.67		not stated; modified itt; registry:outcomes
28	A3	change	0.29 percent				not stated; modified itt; R0004430:Table 1
28	A3	change	0.29 percent	0.101		24	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (8 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
28	A1	change	-11.2 kg				not stated; modified itt; R0004430:Table 1
28	A1	final	83.4 kg	0.86		41	not stated; modified itt; R0014677:Figure 1
28	A1 vs A2	md	-4.3 kg		-6.8 to -1.9		not stated; modified itt; R0014677:Results
28	A1 vs A3	md	-11.2 kg		-14.0 to -8.4		not stated; modified itt; R0014677:Results
28	A2	change	-6.9 kg				not stated; modified itt; R0004430:Table 1
28	A2	final	87.7 kg	0.86		43	not stated; modified itt; R0014677:Figure 1
28	A3	change	0.0 kg				not stated; modified itt; R0004430:Table 1
28	A3	final	94.6 kg	1.10		24	not stated; modified itt; R0014677:Figure 1

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 45	not stated; safety; registry:adverse_events
A2	events	0 / 44	not stated; safety; registry:adverse_events
A3	events	0 / 28	not stated; safety; registry:adverse_events

Hospitalization for heart failure (1 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A2	events				0 / 44	not stated; safety; registry:adverse_events

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 45	not stated; safety; registry:adverse_events
A2	events	0 / 44	not stated; safety; registry:adverse_events
A3	events	2 / 28	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 45	not stated; randomized; registry:flow
A2	events	0 / 44	not stated; randomized; registry:flow
A3	events	3 / 28	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	11 / 45	not stated; safety; registry:adverse_events
A2	events	13 / 44	not stated; safety; registry:adverse_events
A3	events	7 / 28	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	3 / 45	not stated; safety; registry:adverse_events
A2	events	5 / 44	not stated; safety; registry:adverse_events
A3	events	1 / 28	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	9 / 45	not stated; safety; registry:adverse_events
A2	events	13 / 44	not stated; safety; registry:adverse_events
A3	events	6 / 28	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	6 / 45	not stated; safety; registry:adverse_events
A2	events	8 / 44	not stated; safety; registry:adverse_events
A3	events	0 / 28	not stated; safety; registry:adverse_events

Acute pancreatitis (3 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 45	not stated; safety; subacute pancreatitis; registry:adverse_events
A2	events	0 / 44	not stated; safety; subacute pancreatitis; registry:adverse_events
A3	events	1 / 28	not stated; safety; subacute pancreatitis; registry:adverse_events

Death by suicide (3 lines; O35B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 45	not stated; safety; registry:adverse_events
A2	events	0 / 44	not stated; safety; registry:adverse_events
A3	events	0 / 28	not stated; safety; registry:adverse_events