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

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Lilly

Status and phase

Active, not recruiting
Phase 4

Conditions

Type 2 Diabetes

Treatments

Drug: Tirzepatide
Drug: Antihyperglycemic medication

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)

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

Trial contacts and locations

89

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CT LILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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