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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05691712

Collaborator

(none)

256

Enrollment

Locations

Arms

18.8

Anticipated Duration (Months)

8.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Type 2 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disease Endocrine System Diseases	Drug: Tirzepatide Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 6, 2023

Anticipated Primary Completion Date :

Aug 30, 2024

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second People's Hospital of Hefei	Hefei	Anhui	China	230011
2	Beijing Hospital	Beijing	Beijing	China	100005
3	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing	China	100020
4	Beijing Pinggu District Hospital	Beijing	Beijing	China	101200
5	Chongqing General Hospital	Chongqing	Chongqing	China	400014
6	Huizhou Municipal Central Hospital	Huizhou	Guangdong	China	516001
7	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
8	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
9	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan	China	471003
10	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450014
11	The First People's Hospital of Yueyang	Yueyang	Hunan	China	414000
12	Baotou Central Hospital	Bao Tou	Inner Mongolia	China	014040
13	Changzhou No.2 People's Hospital	Changzhou	Jiangsu	China	213000
14	Nanjing First Hospital	Nanjing	Jiangsu	China	210006
15	Zhongda Hospital Southeast University	Nanjing	Jiangsu	China	210009
16	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210011
17	The Affiliated Jiangyin Hospital of Southeast University Medical College	Wuxi Shi	Jiangsu	China	214400
18	Wuxi People's Hospital	Wuxi	Jiangsu	China	214003
19	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu	China	212000
20	The Third Hospital of Nanchang	Nanchang	Jiangxi	China	330009
21	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi	China	337055
22	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shaanxi	China	710077
23	Jinan Central Hospital	Jinan	Shandong	China	250013
24	West China Hospital of Sichuan University	Cheng Du	Sichuan	China	610041
25	Chengdu Fifth People's Hospital	Chengdu	Sichuan	China	611130
26	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
27	Tianjin Medical University Zhu Xianyi Memorial Hospital	Tianjin	Tianjin	China
28	The First People's Hospital of Yunnan Province	Kunming	Yunnan	China	650034
29	Huzhou Central Hospital	Huzhou	Zhejiang	China	313000

Sponsors and Collaborators

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