Phase 3 · Tirzepatide

SURPASS-CN-INS trial results

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

Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg]) (millimoles per mole (mmol/mol)), Baseline, Week 40. 10 mg Tirzepatide: -26.1; 15 mg Tirzepatide: -25.9; Placebo: -9.96.

Participants: 257
Status: completed
Completed: 2024-07-01
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT05691712), updated at source Aug 8, 2025. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What SURPASS-CN-INS measured first

Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])millimoles per mole (mmol/mol) · Baseline, Week 40 · least squares mean

10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
-26.1(1.367)	-25.9(1.386)	-9.96(1.340)

Side effects by arm

Side effects in SURPASS-CN-INS

Percent of participants affected, Baseline up to week 44. The most common events the registry lists.

Event	5 mg Tirzepatide	10 mg Tirzepatide	15 mg Tirzepatide	Placebo
Any serious event	12.3%	7.7%	12.7%	10.9%
Diarrhoea	26.2%	36.9%	36.5%	7.8%
Decreased appetite	29.2%	24.6%	31.7%	0%
Lipase increased	18.5%	21.5%	9.5%	3.1%
Upper respiratory tract infection	20%	16.9%	17.5%	14.1%
Amylase increased	6.2%	12.3%	4.8%	3.1%
Nausea	4.6%	10.8%	11.1%	3.1%
Abdominal distension	10.8%	4.6%	6.3%	0%
Hyperuricaemia	6.2%	4.6%	9.5%	3.1%
Vomiting	6.2%	9.2%	6.3%	0%
Hyperlipidaemia	3.1%	7.7%	4.8%	6.3%
Toothache	4.6%	3.1%	0%	6.3%
Blood creatine phosphokinase increased	3.1%	0%	0%	6.3%
Cough	3.1%	1.5%	0%	6.3%
Palpitations	0%	6.2%	0%	3.1%
Constipation	6.2%	3.1%	3.2%	1.6%
Dyspepsia	6.2%	0%	3.2%	1.6%
Fatigue	0%	6.2%	1.6%	3.1%
Headache	4.6%	6.2%	0%	0%
Benign prostatic hyperplasia	4.8%	5%	0%	0%

Secondary outcomes

What else it measured

Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)mmol/mol · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=62	Placebon=58
-23.0(1.329)	-9.96(1.340)

Mean Change From Baseline in Body Weightkilograms (kg) · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
-2.7(0.52)	-4.8(0.54)	-4.3(0.55)	1.7(0.53)

Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)percentage of participants · Week 40 · number

Measure	5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
HbA1c <7.0%	75.81	78.95	78.18	17.24
HbA1c ≤6.5%	59.68	77.19	69.09	6.90

Mean Change From Baseline in Fasting Serum Glucosemilligram per deciliter (mg/dL) · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
-45.5(3.73)	-52.5(3.87)	-51.0(3.94)	-23.7(3.84)

Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]percentage of participants · Week 40 · number

10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
17.54	25.45	0.00

Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]percentage of participants · Week 40 · number

5 mg Tirzepatiden=62	Placebon=58
9.68	0.00

Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profilesmillimoles per liter per day(mmol/L/day) · Baseline, Week 40 · least squares mean

Measure	5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=63
Morning Premeal - Fasting	-2.62(0.127)	-2.53(0.132)	-2.80(0.136)	-2.22(0.131)
Morning 2-hour Postmeal	-4.78(0.300)	-5.34(0.306)	-5.05(0.313)	-2.57(0.300)
Midday Premeal	-2.87(0.247)	-3.52(0.258)	-3.26(0.263)	-1.32(0.253)
Midday 2-hour Postmeal	-4.05(0.318)	-4.10(0.325)	-3.65(0.335)	-1.46(0.322)
Evening Premeal	-2.84(0.264)	-3.64(0.276)	-3.20(0.285)	-0.95(0.271)
Evening 2-hour Postmeal	-3.97(0.347)	-4.52(0.351)	-4.42(0.367)	-1.47(0.346)
Bedtime	-3.41(0.287)	-4.19(0.297)	-3.85(0.307)	-1.71(0.298)

Percentage of Participants Who Achieved Weight Loss of ≥5%percentage of participants · Week 40 · number

5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
25.81	49.12	60.00	1.72

Percentage of Participants Who Achieved Weight Loss of ≥10%percentage of participants · Week 40 · number

5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
8.06	21.05	25.45	0.00

Percentage of Participants Who Achieved Weight Loss of ≥15%percentage of participants · Week 40 · number

5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
4.84	5.26	9.09	0.00

Percent Change From Baseline in Daily Mean Insulin Glargine Dosepercent change · Baseline, Week 40 · least squares mean

5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
23.90(6.424)	21.95(6.471)	18.21(6.364)	69.28(8.826)

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])percentage of participants · Week 40 · number

5 mg Tirzepatiden=62	10 mg Tirzepatiden=57	15 mg Tirzepatiden=55	Placebon=58
59.68	70.18	67.27	5.17

The trial

How SURPASS-CN-INS was run

The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.

5 Milligram (mg) Tirzepatide: Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose injection pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
10 mg Tirzepatide: Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
15 mg Tirzepatide: Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
Placebo: Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Who could join the trial

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.

Published papers

Papers from SURPASS-CN-INS

Guo L, Dong X, Ma J, Liu M, Lu Y, Wang H, Li Q, Li L, Deng Y, Xu J. 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. Lancet Diabetes Endocrinol. 2025 Dec;13(12):1015-1029. doi: 10.1016/S2213-8587(25)00248-7. Epub 2025 Oct 27.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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