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

Phase 3

Completed

• Conditions: Diabetes Type 2; Glucose Metabolism Disorders; Endocrine System Diseases; Metabolic Disease; Diabetes Mellitus
• Interventions: Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT05691712
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-02-05
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2025-07
• Results First Submitted: 2025-07-01
• Results First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Results First Posted: 2025-08-08
• Last Update Posted: 2025-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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 only if their ALT level is ≤3.0 times ULN.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 Milligram (mg) Tirzepatide	Tirzepatide	Participants received 5 mg of tirzepatide administered as subcutaneous (SC) injection via a single-dose injection pen (SDP) once weekly (QW) for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks until the maintenance dose of 5 mg was reached.
10 mg Tirzepatide	Tirzepatide	Participants received 10 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg) until the maintenance dose of 10 mg was reached.
15 mg Tirzepatide	Tirzepatide	Participants received 15 mg of tirzepatide administered as SC injection via a SDP QW for 40 weeks. The starting dose of tirzepatide was 2.5 mg QW, which increased by 2.5 mg every 4 weeks (2.5 mg to 5 mg to 7.5 mg to 10 mg to 12.5 mg to 15 mg) until the maintenance dose of 15 mg was reached.
Placebo	Placebo	Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])	Baseline, Week 40	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least squares (LS) mean was calculated using mixed model repeated measures (MMRM) for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)	Baseline, Week 40	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using MMRM for post-baseline measures: Variable = Baseline + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Mean Change From Baseline in Body Weight	Baseline, Week 40	LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)	Week 40	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100. Percentage of Participants with HbA1c \<7.0% (53 millimole/mole \[mmol/mol\]) and ≤6.5% (48 mmol/mol) is reported here.
Mean Change From Baseline in Fasting Serum Glucose	Baseline, Week 40	LSMean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]	Week 40	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \<5.7% (39 mmol/Mol) is reported here.
Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]	Week 40	HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentage of participants with HbA1c \<5.7% (39 mmol/Mol) is reported here.
Percentage of Participants Who Achieved Weight Loss of ≥5%	Week 40	Percentage of Participants who Achieved Weight Loss ≥5% is reported here.
Percentage of Participants Who Achieved Weight Loss of ≥15%	Week 40	Percentage of Participants who Achieved Weight Loss ≥15% is reported here.
Percent Change From Baseline in Daily Mean Insulin Glargine Dose	Baseline, Week 40	LS Mean was calculated using MMRM for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Change from Baseline) = Unstructured.
Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles	Baseline, Week 40	The SMBG data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. LS Mean was calculated using MMRM for post-baseline measures: Variable = Baseline + Baseline HbA1c (\<=8.0%, \>8.0%) + SGLT2i Use (Yes/No) + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Value) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured.
Percentage of Participants Who Achieved Weight Loss of ≥10%	Week 40	Percentage of Participants who Achieved Weight Loss ≥10% is reported here.
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 \<7.0%, Without Weight Gain (\<0.1 Kilogram \[kg\]) and Without Hypoglycemia, (Blood Glucose \<3.0 mmol/L \<54 Milligram/Deciliter \[mg/dL\]) is reported here
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 ≤6.5%, Without Weight Gain \<0.1 kg and Without Hypoglycemia (Blood glucose \<3.0 mmol/L \[54 mg/dL\]) is reported here.
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 \<7.0%, Without Weight Gain \<0.1 kg and Without Hypoglycemia (Blood Glucose \<3.9 mmol/L \[70 mg/dL\] or Severe Hypoglycemia) is reported here.
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	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) is reported here.

Trial Locations

Locations (25)

The Second People's Hospital of Hefei; 🇨🇳 Hefei, Anhui, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Pinggu District Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing General Hospital; 🇨🇳 Chongqing, Chongqing, China

Huizhou Municipal Central Hospital; 🇨🇳 Huizhou, Guangdong, China

The First Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The Fourth Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Henan University of Science &Technology; 🇨🇳 LuoyangShi, Henan, China

The Second Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

The First People's Hospital of Yueyang; 🇨🇳 Yueyang, Hunan, China

Scroll for more (15 remaining)