SURPASS-CN-INS

CompletedPhase 3Results posted

A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes

A Randomized, Phase 3, Double Blind Trial Comparing the Effect of the Addition of Tirzepatide Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Participants With Type 2 Diabetes

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

257

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c ≥7%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05691712

Org study ID18552

Secondary IDI8F-MC-GPIMEli Lilly and Company

Timeline

Milestones

Study first posted2023-01-20actual

Study start2023-02-05actual

Primary completion2024-07-01actual

Study completion2024-07-01actual

Last update posted2025-08-08actual

Results first posted2025-08-08actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Have type 2 diabetes mellitus (T2DM)

•Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol)

•Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days

•Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²)

Exclusion criteria

•Have type 1 diabetes mellitus (T1DM)

•Have a history of chronic or acute pancreatitis

•Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment

•Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2

•Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months

•Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months

•Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months

•Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory

•Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial only if their ALT level is ≤3.0 times ULN.

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Other (unclassified)

Weight & body composition

8 endpoints

Secondary/registry result

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilograms (kg)	95% CI
5 mg Tirzepatide	-2.7	—
10 mg Tirzepatide	-4.8	—
15 mg Tirzepatide	-4.3	—
Placebo	1.7	—

LS Mean Difference-4.495% CI-5.8 – -2.9p<0.001Mixed Models Analysis

LS Mean Difference-6.595% CI-8.0 – -5.0p<0.001Mixed Models Analysis

LS Mean Difference-6.095% CI-7.5 – -4.5p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants Who Achieved Weight Loss of ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	25.81	—
10 mg Tirzepatide	49.12	—
15 mg Tirzepatide	60.00	—
Placebo	1.72	—

Secondary/registry result

Percentage of Participants Who Achieved Weight Loss of ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	8.06	—
10 mg Tirzepatide	21.05	—
15 mg Tirzepatide	25.45	—
Placebo	0.00	—

Secondary/registry result

Percentage of Participants Who Achieved Weight Loss of ≥15%

Time frame:Week 40

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	4.84	—
10 mg Tirzepatide	5.26	—
15 mg Tirzepatide	9.09	—
Placebo	0.00	—

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieved Weight Loss of ≥15%

Time frame:Week 40

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

23 endpoints

Primary/registry result

Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), millimoles per mole (mmol/mol)	95% CI
10 mg Tirzepatide	-26.1	—
15 mg Tirzepatide	-25.9	—
Placebo	-9.96	—

LS Mean Difference-16.195% CI-19.9 – -12.36p<0.001Mixed Models Analysis

LS Mean Difference-15.995% CI-19.7 – -12.10p<0.001Mixed Models Analysis

Primary/protocol endpoint

Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), mmol/mol	95% CI
5 mg Tirzepatide	-23.0	—
Placebo	-9.96	—

LS Mean Difference-13.0695% CI-16.8 – -9.34p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg TirzepatideHbA1c <7.0%	75.81	—
HbA1c ≤6.5%	59.68	—
10 mg TirzepatideHbA1c <7.0%	78.95	—
HbA1c ≤6.5%	77.19	—
15 mg TirzepatideHbA1c <7.0%	78.18	—
HbA1c ≤6.5%	69.09	—
PlaceboHbA1c <7.0%	17.24	—
HbA1c ≤6.5%	6.90	—

Secondary/registry result

Mean Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), milligram per deciliter (mg/dL)	95% CI
5 mg Tirzepatide	-45.5	—
10 mg Tirzepatide	-52.5	—
15 mg Tirzepatide	-51.0	—
Placebo	-23.7	—

LS Mean Difference-21.995% CI-32.4 – -11.3p<0.001Mixed Models Analysis

LS Mean Difference-28.995% CI-39.6 – -18.1p<0.001Mixed Models Analysis

LS Mean Difference-27.395% CI-38.2 – -16.5p<0.001Mixed Models Analysis

Secondary/registry result

Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
10 mg Tirzepatide	17.54	—
15 mg Tirzepatide	25.45	—
Placebo	0.00	—

Secondary/registry result

Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	9.68	—
Placebo	0.00	—

Secondary/registry result

Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles

Time frame:Baseline, Week 40

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimoles per liter per day(mmol/L/day)	95% CI
5 mg TirzepatideMorning Premeal - Fasting	-2.62	—
Morning 2-hour Postmeal	-4.78	—
Midday Premeal	-2.87	—
Midday 2-hour Postmeal	-4.05	—
Evening Premeal	-2.84	—
Evening 2-hour Postmeal	-3.97	—
Bedtime	-3.41	—
10 mg TirzepatideMorning Premeal - Fasting	-2.53	—
Morning 2-hour Postmeal	-5.34	—
Midday Premeal	-3.52	—
Midday 2-hour Postmeal	-4.10	—
Evening Premeal	-3.64	—
Evening 2-hour Postmeal	-4.52	—
Bedtime	-4.19	—
15 mg TirzepatideMorning Premeal - Fasting	-2.80	—
Morning 2-hour Postmeal	-5.05	—
Midday Premeal	-3.26	—
Midday 2-hour Postmeal	-3.65	—
Evening Premeal	-3.20	—
Evening 2-hour Postmeal	-4.42	—
Bedtime	-3.85	—
PlaceboMorning Premeal - Fasting	-2.22	—
Morning 2-hour Postmeal	-2.57	—
Midday Premeal	-1.32	—
Midday 2-hour Postmeal	-1.46	—
Evening Premeal	-0.95	—
Evening 2-hour Postmeal	-1.47	—
Bedtime	-1.71	—

Secondary/registry result

Percent Change From Baseline in Daily Mean Insulin Glargine Dose

Time frame:Baseline, Week 40

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	95% CI
5 mg Tirzepatide	23.90	—
10 mg Tirzepatide	21.95	—
15 mg Tirzepatide	18.21	—
Placebo	69.28	—

Secondary/registry result

Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL])

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	59.68	—
10 mg Tirzepatide	70.18	—
15 mg Tirzepatide	67.27	—
Placebo	5.17	—

Secondary/registry result

Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL])

Time frame:Week 40

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Body weight, absolute change (kg), Documented hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	46.77	—
10 mg Tirzepatide	70.18	—
15 mg Tirzepatide	61.82	—
Placebo	1.72	—

Secondary/registry result

Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Severe hypoglycemia

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	51.61	—
10 mg Tirzepatide	57.89	—
15 mg Tirzepatide	47.27	—
Placebo	5.17	—

Secondary/registry result

Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Severe hypoglycemia

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
5 mg Tirzepatide	38.71	—
10 mg Tirzepatide	57.89	—
15 mg Tirzepatide	43.64	—
Placebo	1.72	—

Secondary/protocol endpoint

Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles

Time frame:Baseline, Week 40

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With HbA1c <7.0%, Without Weight Gain (<0.1 Kilogram [kg]) and Without Hypoglycemia, (Blood Glucose <3.0 mmol/L <54 Milligram/Deciliter [mg/dL])

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.0 mmol/L [54 mg/dL])

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c <7.0%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Severe hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants With HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood Glucose <3.9 mmol/L [70 mg/dL] or Severe Hypoglycemia)

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

componentsHbA1c <6.5% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Severe hypoglycemia

LOINC 4548-4

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Percent Change From Baseline in Daily Mean Insulin Glargine Dose

Time frame:Baseline, Week 40

percent change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and safety of tirzepatide added to basal insulin in patients with type 2 diabetes in China (SURPASS-CN-INS): a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial.
The lancet. Diabetes & endocrinology2025 Dec (month)PMID41167231doi:10.1016/S2213-8587(25)00248-7via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.