parallel randomized trial

NCT04235959

A Multiple Dose Titration Study in Chinese Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Tirzepatide

Type 2 diabetes (adults)NCT04235959S000277

Design

Randomized: 24
Start year: 2020
Treatment: 24 weeks, follow-up 28 weeks
Countries: China
Sponsor: Eli Lilly and Company (industry)
Eligibility: Chinese adults 20 to 70 years, HbA1c 7.0 to 10.5 diet only or 6.5 to 10.0 on one OAM, BMI 23 or more

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: safety
Missing data

Arms

Arm	Treatment	Background	Randomized
A1	Placebo Placebo	none; oral agents washed out; lifestyle: not reported	4
A2	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 2.5 to 10.0 mg	none; oral agents washed out; lifestyle: not reported	10
A3	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 2.5 to 15.0 mg	none; oral agents washed out; lifestyle: not reported	10

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Tirzepatide 10 mg subcutaneous once weekly A2	Tirzepatide 15 mg subcutaneous once weekly A3
age	mean (years)	56.5	55.8	56.8
age	sd (years)	7.5	5.2	5.4
bmi	mean (kg/m2)	26.4	26.0	25.1
bmi	sd (kg/m2)	1.8	2.9	1.6
diabetes duration	mean (years)	5.3	6.6	6.6
diabetes duration	sd (years)	2.1	4.1	4.0
female	n	1	6	4
female	percent	25	60	40
hba1c	mean (percent)	7.8	8.2	7.7
hba1c	sd (percent)	0.7	1.2	1.1
weight	mean (kg)	71.3	65.0	67.6
weight	sd (kg)	7.1	8.5	6.8

Analyses this trial contributes to

Results

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

HbA1c change (4 lines; O01)

Week	Arm	Statistic	Estimate	Events / N	Detail
16	A1	change	1.1 percent	4	not stated; modified itt; R0019570:Supplement Table S2
16	A2	change	-2.4 percent	10	not stated; modified itt; R0019570:Supplement Table S2
24	A1	change	-0.2 percent		not stated; modified itt; R0019570:Supplement Table S2
24	A3	change	-1.6 percent	10	not stated; modified itt; R0019570:Supplement Table S2

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

Week	Arm	Statistic	Estimate	Detail
16	A1	change	-0.9 kg	not stated; modified itt; R0019570:Results
16	A2	change	-4.2 kg	not stated; modified itt; R0019570:Results
24	A1	change	-3.4 kg	not stated; modified itt; R0019570:Results
24	A3	change	-6.7 kg	not stated; modified itt; R0019570:Results

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

Arm	Statistic	Events / N	Detail
A1	events	0 / 4	not stated; safety; R0019570:Table 2
A2	events	1 / 10	not stated; safety; R0019570:Table 2
A3	events	1 / 10	not stated; safety; R0019570:Table 2

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 4	not stated; safety; registry:adverse_events
A2	events	0 / 10	not stated; safety; registry:adverse_events
A3	events	0 / 10	not stated; safety; registry:adverse_events

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	1 / 4	not stated; safety; R0019570:Table 2
A2	events	0 / 10	not stated; safety; R0019570:Table 2
A3	events	0 / 10	not stated; safety; R0019570:Table 2

Discontinuation due to adverse events (6 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	1 / 4	not stated; safety; R0019570:Table 2
A1	events	1 / 4	not stated; randomized; registry:flow
A2	events	0 / 10	not stated; safety; R0019570:Table 2
A2	events	0 / 10	not stated; randomized; registry:flow
A3	events	0 / 10	not stated; safety; R0019570:Table 2
A3	events	0 / 10	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 4	not stated; safety; R0019570:Table 2
A2	events	1 / 10	not stated; safety; R0019570:Table 2
A3	events	4 / 10	not stated; safety; R0019570:Table 2

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	0 / 4	not stated; safety; registry:adverse_events
A2	events	0 / 10	not stated; safety; registry:adverse_events
A3	events	1 / 10	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	0 / 4	not stated; safety; R0019570:Table 2
A2	events	6 / 10	not stated; safety; R0019570:Table 2
A3	events	4 / 10	not stated; safety; R0019570:Table 2