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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |