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)
320 patients around the world
Available in Puerto Rico, Argentina, United States
Eli Lilly and Company
10Research sites
320Patients around the world
This study is for people with
Diabetes
Diabetes mellitus type 2
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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).
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.
Sites
CEDIMBA - DIM Clínica Privada - Buenos Aires
Recruiting
Belgrano 136, Ramos Mejia, Buenos Aires.
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Viamonte, Cdad. Autónoma de Buenos Aires, Argentina
Centro Médico Viamonte SRL - CABA, Buenos Aires
Recruiting
Av. Córdoba 2019, CABA, Buenos Aires
Investigaciones Médicas IMOBA SRL
Recruiting
Viamonte 2168, C1056ABH Cdad. Autónoma de Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Zárate
Recruiting
Florestano Andrade 332, Zárate, Buenos Aires
Instituto de Investigaciones Clínicas - Rosario
Recruiting
Paraguay 160, S2000CVD Rosario, Santa Fe, Argentina
CEDIC Centro de Investigación Clínica - CABA, Buenos Aires
Recruiting
Jerónimo Salguero 2142, CABA, Buenos Aires
Centro Médico Colón
Recruiting
Av. Colon 1864, Córdoba
Centro Médico Cimel Chahin Chahin S.A.
Recruiting
Tucumán 1314, Lanús, Buenos Aires
Centro de Investigaciones Médicas Mar del Plata SRL