parallel randomized trial

NCT03861039

A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo)

Type 2 diabetes (adults)NCT03861039S001385

Design

Randomized: 443
Start year: 2019
Treatment: 52 weeks, follow-up 56 weeks
Countries: Japan
Sponsor: Eli Lilly and Company (industry)
Eligibility: Japanese adults 20 y or older; BMI 23 or more; on OAM monotherapy

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: modified itt
Missing data

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Tirzepatide 5 mg subcutaneous once weekly Tirzepatide 5 mg	OAM monotherapy (SU, biguanide, AGI, TZD, glinide or SGLT2 inhibitor); lifestyle: not reported	148	148
A2	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg	OAM monotherapy (SU, biguanide, AGI, TZD, glinide or SGLT2 inhibitor); lifestyle: not reported	147	147
A3	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	OAM monotherapy (SU, biguanide, AGI, TZD, glinide or SGLT2 inhibitor); lifestyle: not reported	148	148

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	Tirzepatide 10 mg subcutaneous once weekly A2	Tirzepatide 15 mg subcutaneous once weekly A3
age	mean (years)	57.7	56.9	56.5
age	sd (years)	11.0	11.2	10.4
asian	n	148	147	148
black	n	0	0	0
female	n	29	34	44
hba1c	mean (percent)	8.53	8.56	8.59
hba1c	sd (percent)	1.15	1.05	1.09
hispanic	n	0	0	0
white	n	0	0	0

Analyses this trial contributes to

Results

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

HbA1c change (3 lines; O01)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52	A1	change	-2.57 percent	0.075	148	not stated; modified itt; registry:outcomes
52	A2	change	-2.98 percent	0.075	146	not stated; modified itt; registry:outcomes
52	A3	change	-3.02 percent	0.077	145	not stated; modified itt; registry:outcomes

Body weight change in kilograms (diabetes) (3 lines; O02)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
52	A1	change	-3.8 kg	0.51	148	not stated; modified itt; registry:outcomes
52	A2	change	-7.5 kg	0.51	146	not stated; modified itt; registry:outcomes
52	A3	change	-10.2 kg	0.52	145	not stated; modified itt; registry:outcomes

HbA1c below 7 percent (3 lines; O03)

Week	Arm	Statistic	Estimate	Events / N	Detail
52	A1	responders	92.57	148	not stated; modified itt; registry:outcomes
52	A2	responders	97.95	146	not stated; modified itt; registry:outcomes
52	A3	responders	96.55	145	not stated; modified itt; registry:outcomes

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

Arm	Statistic	Events / N	Detail
A1	events	1 / 148	not stated; modified itt; registry:outcomes
A2	events	1 / 147	not stated; modified itt; registry:outcomes
A3	events	3 / 148	not stated; modified itt; registry:outcomes

Weight loss of 5 percent or more (3 lines; O11A)

Week	Arm	Statistic	Estimate	Events / N	Detail
52	A1	responders	43.92	148	not stated; modified itt; registry:outcomes
52	A2	responders	70.55	146	not stated; modified itt; registry:outcomes
52	A3	responders	84.14	145	not stated; modified itt; registry:outcomes

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 148	not stated; safety; registry:adverse_events
A2	events	0 / 147	not stated; safety; registry:adverse_events
A3	events	0 / 148	not stated; safety; registry:adverse_events

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	2 / 148	not stated; safety; registry:adverse_events
A2	events	11 / 147	not stated; safety; registry:adverse_events
A3	events	11 / 148	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	2 / 148	not stated; randomized; registry:flow
A2	events	5 / 147	not stated; randomized; registry:flow
A3	events	11 / 148	not stated; randomized; registry:flow

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	14 / 148	not stated; safety; registry:adverse_events
A2	events	20 / 147	not stated; safety; registry:adverse_events
A3	events	40 / 148	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	4 / 148	not stated; safety; registry:adverse_events
A2	events	11 / 147	not stated; safety; registry:adverse_events
A3	events	15 / 148	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	11 / 148	not stated; safety; registry:adverse_events
A2	events	20 / 147	not stated; safety; registry:adverse_events
A3	events	20 / 148	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	12 / 148	not stated; safety; registry:adverse_events
A2	events	20 / 147	not stated; safety; registry:adverse_events
A3	events	22 / 148	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (9 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 148	not stated; safety; gallbladder polyp; registry:adverse_events
A1	events	0 / 148	not stated; safety; cholelithiasis; registry:adverse_events
A1	events	1 / 148	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	0 / 147	not stated; safety; gallbladder polyp; registry:adverse_events
A2	events	1 / 147	not stated; safety; cholelithiasis; registry:adverse_events
A2	events	1 / 147	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	0 / 148	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	1 / 148	not stated; safety; cholelithiasis; registry:adverse_events
A3	events	2 / 148	not stated; safety; gallbladder polyp; registry:adverse_events