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Clinical Trials in Mexico / NCT05433584
Active, not recruiting Phase 4

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

NCT05433584 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 4
Started
2022-08-01
Last updated
2025-12-12

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Tirzepatide →Antihyperglycemic medication

Tirzepatide: Administered SC

Antihyperglycemic medication: As prescribed

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (90)

FacilityCityRegionStatus
Cahaba Research - Trussville Birmingham Alabama
San Fernando Valley Health Institute Canoga Park California
Velocity Clinical Research, Huntington Park Huntington Park California
Velocity Clinical Research, San Diego La Mesa California
Clinical Trials Research Lincoln California
Velocity Clinical Research, Westlake Los Angeles California
Catalina Research Institute, LLC Montclair California
Velocity Clinical Research, North Hollywood North Hollywood California
Velocity Clinical Research, Panorama City Panorama City California
Western University of Health Sciences Pomona California
Velocity Clinical Research, Santa Ana Santa Ana California
New England Research Associates, LLC Bridgeport Connecticut
Excel Medical Clinical Trials Boca Raton Florida
Alliance for Multispecialty Research, LLC Coral Gables Florida
South Florida Clinical Research Institute Margate Florida
Emory University School of Medicine- Grady Campus Atlanta Georgia
Center for Advanced Research & Education Gainesville Georgia
Qualmedica Research, LLC Evansville Indiana
Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa
Qualmedica Research Bowling Green Kentucky
NECCR PrimaCare Research Fall River Massachusetts
SKY Integrative Medical Center/SKYCRNG Ridgeland Mississippi
StudyMetrix Research City of Saint Peters Missouri
Clinvest Research LLC Springfield Missouri
Research Foundation of SUNY - University of Buffalo Buffalo New York
Lucas Research, Inc Morehead City North Carolina
The Corvallis Clinic, P.C. Corvallis Oregon
Clinical Research of Philadelphia Philadelphia Pennsylvania
Preferred Primary Care Physicians Uniontown Pennsylvania
Tribe Clinical Research, LLC Greenville South Carolina
Velocity Clinical Research, Spartanburg Spartanburg South Carolina
Dallas Diabetes Research Center Dallas Texas
Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata Mar del Plata Buenos Aires
Go Centro Medico San Nicolás San Nicolás de los Arroyos Buenos Aires
CIAD Moron Morón Buenos Air
Centro Médico Viamonte Buenos Aires Ciudad Aut
Dr. M.B. Jones Inc. Victoria British Columbia
Bluewater Clinical Research Group Inc. Sarnia Ontario
Stouffville Medical Centre Stouffville Ontario

+ 50 more sites — see the full list on the official registry below.

On this site

📄 Mounjaro (tirzepatide) drug profile →

More Eli Lilly and Company trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05433584 on ClinicalTrials.gov ↗ ← All trials in Mexico