GZQA
Research type
Research Study
Full title
A Phase 3, Randomized, Multicenter, Double-blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared with Placebo in Adult Participants with Type 2 Diabetes, Moderate or Severe Renal Impairment with Inadequate Glycemic Control on Basal Insulin with or without Metformin and/or SGLT2 inhibitor (TRANSCEND-T2D-3)
IRAS ID
1008972
Contact name
Veronica Acevedo
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
Type 2 diabetes (T2D) is a metabolic condition characterised by impaired glycemic control caused by increased insulin resistance and progressive beta cell failure and consequently inadequate insulin secretion. T2D is frequently associated with comorbidities, such as overweight or obesity, hypertension, increased blood lipoprotein concentrations, and a higher risk for macro- and microvascular complications, including chronic kidney disease (CKD).
Due to the progressive nature of T2D, many people will require basal insulin therapy usually in combination with oral antihyperglycemic medications to reach or maintain glycemic goals. While increasing the basal insulin dose improves glycemic control, it may be associated with
increased risk of hypoglycemia, especially in patients with Stage 3 and 4 CKD, and weight gain, limiting the intensification of basal insulin. Tirzepatide has shown significant improvement in glycemic control, weight reduction, and lower insulin glargine use when compared to placebo.
The purpose of this study is to investigate the efficacy and safety of retatrutide 4 mg, 9 mg, or 12 mg administered once weekly (QW) for 52 weeks compared with placebo for mean change from baseline in HbA1c in participants with T2D with inadequate glycemic control and moderate or severe renal impairment treated with insulin glargine alone or a combination of insulin glargine with or without metformin and/or SGLT2 inhibitor. The combination of insulin glargine and retatrutide is expected to provide improved glycemic control and attenuate the weight gain (or induce weight reduction) associated with the up titration of insulin glargine.
This study will consist of 3 periods - screening (35 days), treatment (52 weeks), and safety follow-up (4 weeks).REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0049
Date of REC Opinion
13 Mar 2024
REC opinion
Further Information Favourable Opinion