Clinical trial
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
Active, not recruiting · Phase 3 · 6 countries · Registry ID NCT06297603
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 placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 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
ConditionType 2 Diabetes
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 moderate or severe renal impairment * Have been on the following stable diabetes treatment during 90 days prior to screening * basal insulin (≥20 International Units (IU)/day) with or without * metformin and/or SGLT2 inhibitor * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2) 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 a history of unstable or rapidly progressing renal disease * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification III or IV congestive heart failure * Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * 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
Placebo
Drug
Administered SC
Primary outcomes
Change from Baseline in Hemoglobin A1c (HbA1c) (%)Baseline, Week 52
Study locations
76 locations were listed when this page was built. The first 40 are shown.
CIPREC🇦🇷 Buenos Aires, Argentina
CIPREC🇦🇷 Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Buenos Aires, Argentina
Centro Médico Viamonte🇦🇷 Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl🇦🇷 Buenos Aires, Argentina
Mautalen Salud e Investigación🇦🇷 Buenos Aires, Argentina
CEDIC🇦🇷 CABA, Argentina
Centro Diabetológico Dr. Waitman🇦🇷 Córdoba, Argentina
Centro Médico Colón🇦🇷 Córdoba, Argentina
Centro de Investigaciones Clínicas Baigorria🇦🇷 Granadero Baigorria, Argentina
CIMeL🇦🇷 Lanus, Argentina
Centro de Investigaciones Médicas Mar del Plata🇦🇷 Mar del Plata, Argentina
DIM Clínica Privada🇦🇷 Ramos Mejía, Argentina
INECO Neurociencias Oroño🇦🇷 Rosario, Argentina
Instituto Médico Catamarca IMEC🇦🇷 Rosario, Argentina
Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica🇦🇷 Rosario, Argentina
Instituto de Investigaciones Clinicas Rosario🇦🇷 Rosario, Argentina
Centro de Diabetes Curitiba🇧🇷 Curitiba, Brazil
Instituto de Ensino e Pesquisa Clinica do Ceara🇧🇷 Fortaleza, Brazil
Centro de Pesquisas Clínicas Dr. Marco Mota🇧🇷 Maceió, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica🇧🇷 Rio de Janeiro, Brazil
Praxis Pesquisa Medica🇧🇷 Santo André, Brazil
Instituto de Pesquisa Clinica🇧🇷 São Paulo, Brazil
CEDOES🇧🇷 Vitória, Brazil
Clalit Health Services - Atlit🇮🇱 Atlit, Israel
Soroka Medical Center🇮🇱 Beersheba, Israel
Institute of Diabetes, Technology and Research - Clalit Health🇮🇱 Herzliya, Israel
Edith Wolfson Medical Center🇮🇱 Holon, Israel
Hadassah Medical Center🇮🇱 Jerusalem, Israel
Sheba Medical Center🇮🇱 Ramat Gan, Israel
Clalit Health Services - Sakhnin Community Clinic🇮🇱 Sakhnin, Israel
Enclifar Ensayos Clínicos Farmacológicos Sc🇲🇽 Chihuahua City, Mexico
Diseno y Planeacion en Investigacion Medica🇲🇽 Guadalajara, Mexico
Medical Care and Research SA de CV🇲🇽 Mérida, Mexico
FAICIC S. de R.L. de C.V.🇲🇽 Veracruz, Mexico
Centro de Endocrinologia Alcantara Gonzalez🇵🇷 Bayamón, Puerto Rico
Isis Clinical Research Center🇵🇷 Guaynabo, Puerto Rico
Mgcendo Llc🇵🇷 San Juan, Puerto Rico
Southmead Hospital🇬🇧 Bristol, United Kingdom