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)

Launched by ELI LILLY AND COMPANY · Mar 1, 2024

Keywords

ClinConnect Summary

This clinical trial, called TRANSCEND-T2D-3, is exploring the effectiveness and safety of a new medication called retatrutide for people with Type 2 diabetes who also have moderate or severe kidney problems. The study is aimed at individuals who are not achieving good blood sugar control while using basal insulin, which is a type of insulin used to manage diabetes. Participants might also be using other medications, such as metformin or SGLT2 inhibitors. The trial will last about 14 months and includes up to 22 visits to the study site.

To be eligible for this study, participants should be between the ages of 65 and 74, have Type 2 diabetes with specific blood sugar levels, and have been stable on their current diabetes medications for at least 90 days. It's important that participants are at a stable weight and meet certain health criteria. However, individuals with Type 1 diabetes, recent serious health issues, or certain other medical conditions would not be eligible. Those who join the study can expect regular check-ups and to receive either the study medication or a placebo (a treatment that looks like the real medication but has no active ingredients) to see how well it works for them.

Gender

ALL

Eligibility 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