A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes (SURPASS-EARLY)

Lilly

Status and phase: Active, not recruiting; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Antihyperglycemic medication; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05433584

2022-5010733-40-00 (Other Identifier)

2022-000130-42 (EudraCT Number)

17205

I8F-MC-GPHE (Other Identifier)

U1111-1282-0263 (Registry Identifier)

Details and patient eligibility

About

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Enrollment: 780 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.

• Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.

• Have been on a stable treatment of metformin only at least 90 days preceding baseline

  • with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
  • <1500 mg/day in case of intolerance of full therapeutic dose.

Exclusion criteria

• Have type 1 diabetes mellitus

• Have a history of chronic or acute pancreatitis any time prior to study entry

• Have a history of

  • proliferative diabetic retinopathy
  • diabetic macular edema, or
  • no proliferative diabetic retinopathy requiring immediate or urgent treatment

• Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry

  • myocardial infarction
  • percutaneous coronary revascularization procedure
  • carotid stenting or surgical revascularization
  • nontraumatic amputation
  • peripheral vascular procedure (e.g., stenting or surgical revascularization)
  • cerebrovascular accident (stroke), or congestive heart failure

• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)

• Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies

• Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.

• Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.

  • Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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780 participants in 2 patient groups

Tirzepatide

Experimental group

Description:

Participants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)

Treatment:

Drug: Tirzepatide

Intensified Conventional Care Dose

Active Comparator group

Description:

Participants will receive an antihyperglycemic medication

Treatment:

Drug: Antihyperglycemic medication