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

Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05691712
• Other study ID #: 18552
• Secondary ID: I8F-MC-GPIM
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 5, 2023
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Metabolic Disease
• Metabolic Diseases

Intervention

Drug:
• Tirzepatide
Administered SC as add-on to the pre-trial background medication.
• Placebo
Administered SC as add-on to the pre-trial background medication.

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongolia
China	Beijing Hospital	Beijing	Beijing
China	Beijing Pinggu District Hospital	Beijing	Beijing
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	Chengdu Fifth People's Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	ChengDu	Sichuan
China	Chongqing General Hospital	Chongqing	Chongqing
China	The First Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second People's Hospital of Hefei	Hefei	Anhui
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Jinan Central Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Henan University of Science &Technology	LuoyangShi	Henan
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The Affiliated Jiangyin Hospital of Southeast University Medical College	WuxiShi	Jiangsu
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shaanxi
China	The First People's Hospital of Yueyang	Yueyang	Hunan
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change from Baseline in HbA1c (Tirzepatide 10 or 15 milligram [mg])		Baseline, Week 40
Secondary	Mean Change from Baseline in HbA1c (Tirzepatide 5 mg)		Baseline, Week 40
Secondary	Mean Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Percentage of Participants with HbA1c <7.0% (53 millimole/mole [mmol/mol]) and =6.5% (48 mmol/mol)		Week 40
Secondary	Mean Change from Baseline in Fasting Serum Glucose		Baseline, Week 40
Secondary	Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 10 mg or 15 mg]		Week 40
Secondary	Percentage of Participants with HbA1c <5.7% (39 mmol/mol) [Tirzepatide 5 mg]		Week 40
Secondary	Mean Change from Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles		Baseline, Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =5%		Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =10%		Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =15%		Week 40
Secondary	Percentage Change from Baseline in Daily Mean Insulin Glargine Dose		Baseline, Week 40
Secondary	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
Secondary	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
Secondary	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
Secondary	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