Clinical Trials in Canada / 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 Canada tracker
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
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)
- Change from Baseline in Hemoglobin A1c (HbA1c) — Baseline, Week 104
Trial sites (90)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Canada
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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 Canada