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Completed

NCT Number: NCT05691712

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second People's Hospital of Hefei, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Primary outcomes

  1. Mean Change From Baseline in HbA1c (Tirzepatide 10 or 15 Milligram [mg])

    Time frame: 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 outcomes

  1. Mean Change From Baseline in HbA1c (Tirzepatide 5 mg)

    Time frame: 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

  2. Mean Change From Baseline in Body Weight

    Time frame: 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

  3. Percentage of Participants With HbA1c <7.0% (53 Millimole/Mole [mmol/Mol]) and ≤6.5% (48 mmol/Mol)

    Time frame: 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.

  4. Mean Change From Baseline in Fasting Serum Glucose

    Time frame: 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

  5. Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 10 mg or 15 mg]

    Time frame: 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.

  6. Percentage of Participants With HbA1c <5.7% (39 mmol/Mol) [Tirzepatide 5 mg]

    Time frame: 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.

  7. Mean Change From Baseline in Daily Average 7-point Self-monitored Blood Glucose Profiles

    Time frame: 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.

  8. Percentage of Participants Who Achieved Weight Loss of ≥5%

    Time frame: Week 40

    Percentage of Participants who Achieved Weight Loss ≥5% is reported here.

  9. Percentage of Participants Who Achieved Weight Loss of ≥10%

    Time frame: Week 40

    Percentage of Participants who Achieved Weight Loss ≥10% is reported here.

  10. Percentage of Participants Who Achieved Weight Loss of ≥15%

    Time frame: Week 40

    Percentage of Participants who Achieved Weight Loss ≥15% is reported here.

  11. Percent Change From Baseline in Daily Mean Insulin Glargine Dose

    Time frame: 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.

  12. 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])

    Time frame: 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

  13. 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])

    Time frame: 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.

  14. 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)

    Time frame: 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.

  15. 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: SURPASS-CN-INS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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