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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glucose Metabolism Disorders; Diabetes Mellitus; Endocrine System Diseases; Metabolic Disease; Diabetes Type 2
• Intervention / Treatment: Drug: Tirzepatide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230011
      • The Second People's Hospital of Hefei
      • Contact: Phone Number: 13500507079
      • Principal Investigator: Wu Dai
  • Beijing
    • Beijing, Beijing, China, 101200
      • Beijing Pinggu District Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Chongqing General Hospital
      • Principal Investigator: Hong Man Wang
  • Guangdong
    • Huizhou, Guangdong, China, 516001
      • Huizhou Municipal Central Hospital
      • Principal Investigator: Shu Li
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The First Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Hospital of Harbin Medical University
  • Henan
    • Luoyang Shi, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University
  • Hunan
    • Yueyang, Hunan, China, 414000
      • The First People's Hospital of Yueyang
  • Inner Mongolia
    • Bao Tou, Inner Mongolia, China, 014040
      • Baotou Central Hospital
      • Principal Investigator: Yan Zhu
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital
    • Wuxi Shi, Jiangsu, China, 214400
      • The Affiliated Jiangyin Hospital of Southeast University Medical College
    • Zhenjiang, Jiangsu, China, 212000
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330009
      • The Third Hospital of Nanchang
  • Shaanxi
    • Xi'an, Shaanxi, China, 710077
      • The First Affiliated Hospital of Xi'an Medical University
      • Principal Investigator: Ya Li
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Sichuan
    • Cheng Du, Sichuan, China, 610041
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China, 611130
      • Chengdu Fifth People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Huzhou, Zhejiang, China, 313000
      • Huzhou Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 mg Tirzepatide; 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.	Drug: Tirzepatide; Administered SC as add-on to the pre-trial background medication.; Other Names: LY3298176
Experimental: 10 mg Tirzepatide; 10 mg tirzepatide administered SC once a week.	Drug: Tirzepatide; Administered SC as add-on to the pre-trial background medication.; Other Names: LY3298176
Experimental: 15 mg Tirzepatide; 15 mg tirzepatide administered SC once a week.	Drug: Tirzepatide; Administered SC as add-on to the pre-trial background medication.; Other Names: LY3298176
Placebo Comparator: Placebo; Participants will receive a tirzepatide matched placebo.	Drug: Placebo; Administered SC as add-on to the pre-trial background medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Change from Baseline in HbA1c (Tirzepatide 10 or 15 milligram [mg])	Baseline, Week 40

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 5 mg]	Week 40
Mean Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles	Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5%	Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10%	Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15%	Week 40
Percentage Change from Baseline in Daily Mean Insulin Glargine Dose	Baseline, Week 40
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])	Week 40
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])	Week 40
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)	Week 40
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)	Week 40

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 18552; I8F-MC-GPIM (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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