Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name SURPASS-CN-INS

NCTNCT05691712Other id18552Other idI8F-MC-GPIM

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 257 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Randomized · Double masking
Countries: 1 country
China
Start: 5 Feb 2023
Primary completion: 1 Jul 2024
Completion: 1 Jul 2024
First posted: 20 Jan 2023
Last update posted: 8 Aug 2025
Conditions: Diabetes Type 2 · Diabetes Mellitus · Glucose Metabolism Disorders · Metabolic Disease · Endocrine System Diseases

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 3
SURPASS-CN-INS
NCT05691712
5 Feb 2023 to 1 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TirzepatideDrug
PlaceboDrug

Arms4

Experimental
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.
Experimental
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.
Experimental
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 comparator
Placebo
Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])
Time frame · Baseline, Week 40
Registry description
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

Secondary outcomes(15)

Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)
Time frame · Baseline, Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using 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
Mean Change From Baseline in Body Weight
Time frame · Baseline, Week 40
Registry description
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + 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
Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)
Time frame · Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of Participants with HbA1c \<7.0% (53 millimole/mole \[mmol/mol\]) and ≤6.5% (48 mmol/mol) is reported here.
Mean Change From Baseline in Fasting Serum Glucose
Time frame · Baseline, Week 40
Registry description
LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + 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
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]
Time frame · Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \<5.7% (39 mmol/Mol) is reported here.
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]
Time frame · Week 40
Registry description
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \<5.7% (39 mmol/Mol) is reported here.
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Time frame · Baseline, Week 40
Registry description
The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + 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.
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time frame · Week 40
Registry description
Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Percentage of Participants Who Achieved Weight Loss of ≥10%
Time frame · Week 40
Registry description
Percentage of Participants who Achieved Weight Loss ≥10% is reported here.
Percentage of Participants Who Achieved Weight Loss of ≥15%
Time frame · Week 40
Registry description
Percentage of Participants who Achieved Weight Loss ≥15% is reported here.
Percent Change From Baseline in Daily Mean Insulin Glargine Dose
Time frame · Baseline, Week 40
Registry description
LS Mean was calculated using MMRM for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
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
Registry description
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 \[mg/dL\]) is reported here
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
Registry description
Percentage of Participants with HbA1c ≤6.5%, Without Weight Gain \<0.1 kg and Without Hypoglycemia (Blood glucose \<3.0 mmol/L \[54 mg/dL\]) is reported here.
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
Registry description
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) is reported here.
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
Registry description
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) is reported here.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 40

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

Group	Value (millimoles per mole (mmol/mol))	Spread
10 mg Tirzepatide	-26.1	1.367
15 mg Tirzepatide	-25.9	1.386
Placebo	-9.96	1.340

Secondary and other outcome results(7)

Secondary outcomeLeast squares mean· Baseline, Week 40

Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)

Group	Value (mmol/mol)	Spread
5 mg Tirzepatide	-23.0	1.329
Placebo	-9.96	1.340

Secondary outcomeLeast squares mean· Baseline, Week 40

Mean Change From Baseline in Body Weight

Group	Value (kilograms (kg))	Spread
5 mg Tirzepatide	-2.7	0.52
10 mg Tirzepatide	-4.8	0.54
15 mg Tirzepatide	-4.3	0.55
Placebo	1.7	0.53

Secondary outcomeNumber· Week 40

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

Group	Value (percentage of participants)
5 mg Tirzepatide	75.81
10 mg Tirzepatide	78.95
15 mg Tirzepatide	78.18
Placebo	17.24

Secondary outcomeLeast squares mean· Baseline, Week 40

Mean Change From Baseline in Fasting Serum Glucose

Group	Value (milligram per deciliter (mg/dL))	Spread
5 mg Tirzepatide	-45.5	3.73
10 mg Tirzepatide	-52.5	3.87
15 mg Tirzepatide	-51.0	3.94
Placebo	-23.7	3.84

Secondary outcomeNumber· Week 40

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

Group	Value (percentage of participants)
10 mg Tirzepatide	17.54
15 mg Tirzepatide	25.45
Placebo	0.00

Secondary outcomeNumber· Week 40

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

Group	Value (percentage of participants)
5 mg Tirzepatide	9.68
Placebo	0.00

Secondary outcomeLeast squares mean· Baseline, Week 40

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

Group	Value (millimoles per liter per day(mmol/L/day))	Spread
5 mg Tirzepatide	-2.62	0.127
10 mg Tirzepatide	-2.53	0.132
15 mg Tirzepatide	-2.80	0.136
Placebo	-2.22	0.131

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
5 mg TirzepatideParticipants received 5 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 until the maintenance dose of 5 mg was reached.	1 / 65	8 / 65	45 / 65
10 mg TirzepatideParticipants 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.	0 / 65	5 / 65	49 / 65
15 mg TirzepatideParticipants 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.	0 / 63	8 / 63	49 / 63
PlaceboParticipants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.	0 / 64	7 / 64	31 / 64

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

18 results

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.

Guo et al. 2025The lancet. Diabetes & endocrinologycited by 4

PMID 41167231DOI 10.1016/s2213-8587(25)00248-7PUB-41167231

Full text at the publisher18 results

Publisher page See results (18)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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