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A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes (SURPASS-CN-INS)

Primary Purpose

Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Second People's Hospital of HefeiRecruiting
  • Beijing ChaoYang Hospital
  • Beijing Pinggu District HospitalRecruiting
  • Chongqing General HospitalRecruiting
  • Huizhou Municipal Central HospitalRecruiting
  • The First Hospital of Harbin Medical UniversityRecruiting
  • The First Affiliated Hospital of Henan University of Science &TechnologyRecruiting
  • The Second Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The First People's Hospital of YueyangRecruiting
  • Baotou Central HospitalRecruiting
  • Changzhou No.2 People's HospitalRecruiting
  • Nanjing First HospitalRecruiting
  • Zhongda Hospital Southeast UniversityRecruiting
  • The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • The Affiliated Jiangyin Hospital of Southeast University Medical CollegeRecruiting
  • Wuxi People's HospitalRecruiting
  • The Third Hospital of NanchangRecruiting
  • Dalian University - The Affiliated Zhongshan Hospital
  • The First Affiliated Hospital of Xi'an Medical UniversityRecruiting
  • Jinan Central HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Chengdu Fifth People's HospitalRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Tianjin Medical University Zhu Xianyi Memorial Hospital
  • The First People's Hospital of Yunnan Province
  • Huzhou Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

Placebo

Arm Description

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

10 mg tirzepatide administered SC once a week.

15 mg tirzepatide administered SC once a week.

Participants will receive a tirzepatide matched placebo.

Outcomes

Primary Outcome Measures

Mean Change from Baseline in HbA1c (Tirzepatide 10 or 15 milligram [mg])

Secondary Outcome Measures

Mean Change from Baseline in HbA1c (Tirzepatide 5 mg)
Mean Change from Baseline in Body Weight
Percentage of Participants with HbA1c <7.0% (53 millimole/mole [mmol/mol]) and ≤6.5% (48 mmol/mol)
Mean Change from Baseline in Fasting Serum Glucose
Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 10 mg or 15 mg]
Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 5 mg]
Mean Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Percentage of Participants Who Achieved Weight Loss of ≥5%
Percentage of Participants Who Achieved Weight Loss of ≥10%
Percentage of Participants Who Achieved Weight Loss of ≥15%
Percentage Change from Baseline in Daily Mean Insulin Glargine Dose
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 with HbA1c ≤6.5%, Without Weight Gain <0.1 kg and Without Hypoglycemia (Blood glucose <3.0 mmol/L [54 mg/dL])
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)
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)

Full Information

First Posted
January 11, 2023
Last Updated
October 5, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05691712
Brief Title
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes
Acronym
SURPASS-CN-INS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 mg tirzepatide administered SC once a week.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 mg tirzepatide administered SC once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a tirzepatide matched placebo.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC as add-on to the pre-trial background medication.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC as add-on to the pre-trial background medication.
Primary Outcome Measure Information:
Title
Mean Change from Baseline in HbA1c (Tirzepatide 10 or 15 milligram [mg])
Time Frame
Baseline, Week 40
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in HbA1c (Tirzepatide 5 mg)
Time Frame
Baseline, Week 40
Title
Mean Change from Baseline in Body Weight
Time Frame
Baseline, Week 40
Title
Percentage of Participants with HbA1c <7.0% (53 millimole/mole [mmol/mol]) and ≤6.5% (48 mmol/mol)
Time Frame
Week 40
Title
Mean Change from Baseline in Fasting Serum Glucose
Time Frame
Baseline, Week 40
Title
Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 10 mg or 15 mg]
Time Frame
Week 40
Title
Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 5 mg]
Time Frame
Week 40
Title
Mean Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles
Time Frame
Baseline, Week 40
Title
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time Frame
Week 40
Title
Percentage of Participants Who Achieved Weight Loss of ≥10%
Time Frame
Week 40
Title
Percentage of Participants Who Achieved Weight Loss of ≥15%
Time Frame
Week 40
Title
Percentage Change from Baseline in Daily Mean Insulin Glargine Dose
Time Frame
Baseline, Week 40
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
The Second People's Hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230011
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13500507079
First Name & Middle Initial & Last Name & Degree
Wu Dai
Facility Name
Beijing ChaoYang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
01085231000
First Name & Middle Initial & Last Name & Degree
Guang Wang
Facility Name
Beijing Pinggu District Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101200
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13911080328
First Name & Middle Initial & Last Name & Degree
yufeng li
Facility Name
Chongqing General Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8613983685857
First Name & Middle Initial & Last Name & Degree
Hongman Wang
Facility Name
Huizhou Municipal Central Hospital
City
Huizhou
State/Province
Guangdong
ZIP/Postal Code
516001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu Li
Facility Name
The First Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Kuang
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang Shi
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hongwei Jiang
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15838123695
First Name & Middle Initial & Last Name & Degree
Qingju Li
Facility Name
The First People's Hospital of Yueyang
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414000
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13007301236
First Name & Middle Initial & Last Name & Degree
Xiaoyue Wang
Facility Name
Baotou Central Hospital
City
Bao Tou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhu
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8613616125500
First Name & Middle Initial & Last Name & Degree
Xinhua Ye
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ling li
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yibing Lu
Facility Name
The Affiliated Jiangyin Hospital of Southeast University Medical College
City
Wuxi Shi
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenlong Huang
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
051082700775
First Name & Middle Initial & Last Name & Degree
lan xu
Facility Name
The Third Hospital of Nanchang
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330009
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
13479111177
First Name & Middle Initial & Last Name & Degree
Peng Duan
Facility Name
Dalian University - The Affiliated Zhongshan Hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
13940839879
First Name & Middle Initial & Last Name & Degree
Wei Duan
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710077
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Li
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
15318816218
First Name & Middle Initial & Last Name & Degree
Xiaolin Dong
Facility Name
West China Hospital of Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18980601658
First Name & Middle Initial & Last Name & Degree
zhenmei an
Facility Name
Chengdu Fifth People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
611130
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8613730683979
First Name & Middle Initial & Last Name & Degree
Hongyi Cao
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
18322017516
First Name & Middle Initial & Last Name & Degree
Ming Liu
Facility Name
Tianjin Medical University Zhu Xianyi Memorial Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Chen
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650034
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
13888612322
First Name & Middle Initial & Last Name & Degree
Yan Wang
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zhejiang
ZIP/Postal Code
313000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianping Yao

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/

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

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