What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Tirzepatide, Antihyperglycemic medication for type 2 diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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.
Study sites by state
Alabama
- Cahaba Research - Trussville — Birmingham
California
- San Fernando Valley Health Institute — Canoga Park
- Velocity Clinical Research, Huntington Park — Huntington Park
- Velocity Clinical Research, San Diego — La Mesa
- Clinical Trials Research — Lincoln
- Velocity Clinical Research, Westlake — Los Angeles
- Catalina Research Institute, LLC — Montclair
- Velocity Clinical Research, North Hollywood — North Hollywood
- Velocity Clinical Research, Panorama City — Panorama City
- Western University of Health Sciences — Pomona
- Velocity Clinical Research, Santa Ana — Santa Ana
Connecticut
- New England Research Associates, LLC — Bridgeport
Florida
- Excel Medical Clinical Trials — Boca Raton
- Alliance for Multispecialty Research, LLC — Coral Gables
- South Florida Clinical Research Institute — Margate
Georgia
- Emory University School of Medicine- Grady Campus — Atlanta
- Center for Advanced Research & Education — Gainesville
Indiana
- Qualmedica Research, LLC — Evansville
Iowa
- Iowa Diabetes and Endocrinology Research Center — West Des Moines
Kentucky
- Qualmedica Research — Bowling Green
Massachusetts
- NECCR PrimaCare Research — Fall River
Mississippi
- SKY Integrative Medical Center/SKYCRNG — Ridgeland
Missouri
- StudyMetrix Research — City of Saint Peters
- Clinvest Research LLC — Springfield
New York
- Research Foundation of SUNY - University of Buffalo — Buffalo
North Carolina
- Lucas Research, Inc — Morehead City
Oregon
- The Corvallis Clinic, P.C. — Corvallis
Pennsylvania
- Clinical Research of Philadelphia — Philadelphia
- Preferred Primary Care Physicians — Uniontown
South Carolina
- Tribe Clinical Research, LLC — Greenville
- Velocity Clinical Research, Spartanburg — Spartanburg
Texas
- Dallas Diabetes Research Center — Dallas
View the official record on ClinicalTrials.gov →
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