Clinical trial
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
Active, not recruiting · Phase 3 · 5 countries · Registry ID NCT06260722
Active, not recruitingPhase 3Interventional
What this study is about
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.
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
ConditionDiabetes Mellitus, Type 2
Full registry criteria
Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) * Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Have Type 1 Diabetes (T1D) * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification IV congestive heart failure * Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * Have a known clinically significant gastric emptying abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.
Treatments and study arms
Retatrutide
Drug
Administered SC.
Semaglutide
Drug
Administered SC.
Primary outcomes
Change from Baseline in Hemoglobin A1c (HbA1c) (%)Baseline, Week 80
Study locations
77 locations were listed when this page was built. The first 40 are shown.
CIPREC🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
Centro Médico Viamonte🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
Fundación Respirar🇦🇷 Buenos Aires, Argentina
Mautalen Salud e Investigación🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
Stat Research S.A.🇦🇷 Buenos Aires, Buenos Aires F.D., Argentina
CEMEDIAB🇦🇷 C.a.b.a., Buenos Aires F.D., Argentina
Instituto Centenario🇦🇷 CABA, Buenos Aires F.D., Argentina
CARE - Centro de Alergia y Enfermedades Respiratorias🇦🇷 Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro Diabetológico Dr. Waitman🇦🇷 Córdoba, Argentina
Centro Medico Privado San Vicente Diabetes🇦🇷 Córdoba, Córdoba Province, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes🇦🇷 Godoy Cruz, Mendoza Province, Argentina
Centro de Investigaciones Clínicas Baigorria🇦🇷 Granadero Baigorria, Santa Fe Province, Argentina
Instituto de Investigaciones Clinicas Rosario🇦🇷 Rosario, Santa Fe Province, Argentina
Aggarwal and Associates Limited🇨🇦 Brampton, Ontario, Canada
Centricity Research Brampton Endocrinology🇨🇦 Brampton, Ontario, Canada
University of Calgary - Clinical Trials Unit🇨🇦 Calgary, Alberta, Canada
Alberta Diabetes Institute🇨🇦 Edmonton, Alberta, Canada
Hamilton Medical Research Group🇨🇦 Hamilton, Ontario, Canada
The Wharton Medical Clinic Clinical Trials Inc🇨🇦 Hamilton, Ontario, Canada
Winterberry Research Inc.🇨🇦 Hamilton, Ontario, Canada
9109-0126 Quebec Inc.🇨🇦 Montreal, Quebec, Canada
Bluewater Clinical Research Group Inc.🇨🇦 Sarnia, Ontario, Canada
Maple Leaf Research🇨🇦 Toronto, Ontario, Canada
Prime Health Clinical Research🇨🇦 Toronto, Ontario, Canada
Private Practice - Dr. Nigel Jagan🇨🇦 Whitby, Ontario, Canada
Enclifar Ensayos Clínicos Farmacológicos Sc🇲🇽 Chihuahua City, Mexico
Instituto de Diabetes, Obesidad y Nutricion🇲🇽 Cuernavaca, Morelos, Mexico
Diseno y Planeacion en Investigacion Medica🇲🇽 Guadalajara, Jalisco, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares🇲🇽 Mexico City, Mexico City, Mexico
Hospital de Jésus, I.A.P.🇲🇽 Mexico City, Mexico City, Mexico
RM Pharma Specialists🇲🇽 Mexico City, Mexico City, Mexico
Cardiolink Clin Trials🇲🇽 Monterrey, Nuevo León, Mexico
Clínica García Flores SC🇲🇽 Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"🇲🇽 Monterrey, Nuevo León, Mexico
Instituto Veracruzano en Investigación Clínica S.C.🇲🇽 Veracruz, Mexico
Advanced Clinical Research, LLC🇵🇷 Bayamón, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site🇵🇷 San Juan, Puerto Rico
University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States