A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

• Status: Not yet recruiting
• Trial end date: 2027-05-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Hypoglycemic Agents; Tirzepatide

Criteria

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.