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

Lilly

Status and phase: Completed; Phase 3

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

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05691712

18552

I8F-MC-GPIM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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257 participants in 4 patient groups, including a placebo group

5 Milligram (mg) Tirzepatide

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

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.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants received tirzepatide matched placebo administered as SC injection via a SDP QW for 40 weeks.

Treatment:

Drug: Placebo