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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