Clinical trial

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

Active, not recruiting · Phase 4 · 7 countries · Registry ID NCT05433584

Active, not recruitingPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes

Full registry criteria

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.

Treatments and study arms

Tirzepatide

Drug

Administered SC

Antihyperglycemic medication

Drug

As prescribed

Primary outcomes

Change from Baseline in Hemoglobin A1c (HbA1c)Baseline, Week 104

Study locations

90 locations were listed when this page was built. The first 40 are shown.

Centro Médico Viamonte🇦🇷 Buenos Aires, Ciudad Aut, Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata🇦🇷 Mar del Plata, Buenos Aires, Argentina
CIAD Moron🇦🇷 Morón, Buenos Air, Argentina
Go Centro Medico San Nicolás🇦🇷 San Nicolás de los Arroyos, Buenos Aires, Argentina
9109-0126 Quebec Inc.🇨🇦 Montreal, Quebec, Canada
Bluewater Clinical Research Group Inc.🇨🇦 Sarnia, Ontario, Canada
Stouffville Medical Centre🇨🇦 Stouffville, Ontario, Canada
Dr. M.B. Jones Inc.🇨🇦 Victoria, British Columbia, Canada
Diabetespraxis Mergentheim🇩🇪 Bad Mergentheim, Germany
Diabetes- und Stoffwechselpraxis Bochum🇩🇪 Bochum, North Rhine-Westphalia, Germany
InnoDiab Forschung Gmbh🇩🇪 Essen, North Rhine-Westphalia, Germany
ClinPhenomics CVC GmbH🇩🇪 Frankfurt am Main, Hesse, Germany
Diabetes Zentrum Dr. Tews🇩🇪 Gelnhausen, Germany
RED-Institut GmbH🇩🇪 Oldenburg in Holstein, Schleswig-Holstein, Germany
Arztpraxis Christine Kosch Pirna🇩🇪 Pirna, Saxony, Germany
Zentrum für klinische Studien🇩🇪 Saint Ingbert, Saarland, Germany
Clalit Health Services - Atlit🇮🇱 Atlit, Southern District, Israel
Bnai Zion Medical Center🇮🇱 Haifa, Northern District, Israel
Linn Medical Center🇮🇱 Haifa, Ḥeifā, Israel
Edith Wolfson Medical Center🇮🇱 Holon, Central District, Israel
Hadassah Medical Center🇮🇱 Jerusalem, Jerusalem, Israel
Rabin Medical Center🇮🇱 Petah Tikva, Central District, Israel
Sheba Medical Center🇮🇱 Ramat Gan, Central District, Israel
Kaplan Medical Center🇮🇱 Rehovot, Central District, Israel
Clalit Health Services - Sakhnin Community Clinic🇮🇱 Sakhnin, Northern District, Israel
A.O.U.C. Policlinico di Bari🇮🇹 Bari, Apulia, Italy
AOU Renato Dulbecco🇮🇹 Catanzaro, Italy
Centro Cardiologico Monzino🇮🇹 Milan, Milano, Italy
Ospedale Civile Santa Croce Pronto Soccorso🇮🇹 Moncalieri, Piedmont, Italy
University of Naples Federico II🇮🇹 Naples, Campania, Italy
Ospedale san Giovanni di Dio-Diabetologia🇮🇹 Olbia, Sardinia, Italy
A.O.U. Policlinico Paolo Giaccone🇮🇹 Palermo, Sicily, Italy
Azienda Ospedaliera Universitaria Pisana🇮🇹 Pisa, Tuscany, Italy
Investigacion En Salud Y Metabolismo Sc🇲🇽 Chihuahua City, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario🇲🇽 Guadalajara, Jalisco, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"🇲🇽 Monterrey, Nuevo León, Mexico
San Juan Bautista School of Medicine - Clinical Research Unit🇵🇷 Caguas, PR, Puerto Rico
Dorado Medical Complex🇵🇷 Dorado, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site🇵🇷 San Juan, PR, Puerto Rico