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NCT05691712CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 8 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
257 (actual)
First submitted
11 Jan 2023
Start date
5 Feb 2023
Primary completion date
1 Jul 2024
Lead sponsor
Eli Lilly and Company
NCT number
NCT05691712

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 257
  • From 5 Feb 2023 to the primary completion date, 1 Jul 2024
  • 25 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Have type 1 diabetes mellitus (T1DM)
  • Have a history of chronic or acute pancreatitis
  • 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

Lab values

  • 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.

Other

  • Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Baotou Central Hospital
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BaotouChinaUnknown status
Beijing Pinggu District Hospital
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BeijingChinaUnknown status
Beijing Hospital
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BeijingChinaUnknown status
Changzhou No.2 People's Hospital
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ChangzhouChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Chengdu Fifth People's Hospital
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ChengduChinaUnknown status
Chongqing General Hospital
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ChongqingChinaUnknown status
The Fourth Hospital of Harbin Medical University
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HarbinChinaUnknown status
The First Hospital of Harbin Medical University
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HarbinChinaUnknown status
The Second People's Hospital of Hefei
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HefeiChinaUnknown status
Huizhou Municipal Central Hospital
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HuizhouChinaUnknown status
Huzhou Central Hospital
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HuzhouChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The First Affiliated Hospital of Henan University of Science &Technology
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LuoyangShiChinaUnknown status
The Third Hospital of Nanchang
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NanchangChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University
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NanjingChinaUnknown status
Nanjing First Hospital
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NanjingChinaUnknown status
Zhongda Hospital Southeast University
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NanjingChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
The Affiliated Jiangyin Hospital of Southeast University Medical College
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WuxiShiChinaUnknown status
The First Affiliated Hospital of Xi'an Medical University
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Xi'anChinaUnknown status
The First People's Hospital of Yueyang
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YueyangChinaUnknown status
The Second Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.