A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
SURPASS-CN-INS
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
2 other identifiers
interventional
257
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2023
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 20, 2023
CompletedStudy Start
First participant enrolled
February 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedResults Posted
Study results publicly available
August 8, 2025
CompletedAugust 8, 2025
July 1, 2025
1.4 years
January 11, 2023
July 1, 2025
July 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Baseline, Week 40
Secondary Outcomes (15)
Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)
Baseline, Week 40
Mean Change From Baseline in Body Weight
Baseline, Week 40
Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)
Week 40
Mean Change From Baseline in Fasting Serum Glucose
Baseline, Week 40
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]
Week 40
- +10 more secondary outcomes
Study Arms (4)
5 Milligram (mg) Tirzepatide
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
The Second People's Hospital of Hefei
Hefei, Anhui, 230011, China
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
Beijing Pinggu District Hospital
Beijing, Beijing Municipality, 101200, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001, China
The First Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
LuoyangShi, Henan, 471003, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
The First People's Hospital of Yueyang
Yueyang, Hunan, 414000, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014040, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213000, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
WuxiShi, Jiangsu, 214400, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330009, China
The First Affiliated Hospital of Xi'an Medical University
Xi'an, Shaanxi, 710077, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 611130, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Huzhou Central Hospital
Huzhou, Zhejiang, 313000, China
Related Publications (1)
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.
PMID: 41167231DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2023
First Posted
January 20, 2023
Study Start
February 5, 2023
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
August 8, 2025
Results First Posted
August 8, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- ata are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.