Status:
ACTIVE_NOT_RECRUITING
A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT05433584
Start Date
August 1 2022
End Date
November 1 2027
Last Update
December 12 2025
Active Locations (90)
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1
Cahaba Research - Trussville
Birmingham, Alabama, United States, 35235
2
San Fernando Valley Health Institute
Canoga Park, California, United States, 91304
3
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States, 90255
4
Velocity Clinical Research, San Diego
La Mesa, California, United States, 91942