Ongoing 3

TRANSCEND-T2D-2

TRANSCEND-T2D-2: Type 2 Diabetes Insulin Combination Trial

Phase 3 trial evaluating retatrutide as add-on to basal insulin in adults with type 2 diabetes inadequately controlled on insulin therapy.

Definition

TRANSCEND-T2D-2 — Phase 3 trial evaluating retatrutide as add-on to basal insulin in adults with type 2 diabetes inadequately controlled on insulin therapy.

Trial Facts

PropertyValue
Trial NameTRANSCEND-T2D-2
Phase3
Statusongoing
Enrollment1,200 participants
Start DateMarch 1, 2024
Conditionstype 2 diabetes

Study Overview

TRANSCEND-T2D-2 evaluates retatrutide as an add-on therapy for patients with type 2 diabetes who are not achieving adequate glycemic control with basal insulin. This population represents a significant unmet need — millions of patients remain above HbA1c targets despite insulin use, and adding medications that also promote weight loss (rather than weight gain) is a key therapeutic goal.

Study Design

Population

Adults with type 2 diabetes:

  • Currently on stable basal insulin (with or without metformin)
  • HbA1c 7.0-10.0%
  • BMI ≥25 kg/m²

Key Question

Can retatrutide improve glycemic control in insulin-treated patients while also reducing body weight and potentially allowing insulin dose reduction?

Endpoints

Primary: HbA1c change from baseline Key secondary:

  • Insulin dose reduction
  • Body weight change
  • Hypoglycemia incidence
  • Proportion achieving HbA1c <7% without clinically significant hypoglycemia

Clinical Context

Insulin therapy often causes weight gain (typically 2-4 kg), creating a vicious cycle in patients with T2D and obesity. A therapy that improves glycemic control while enabling weight loss and insulin dose reduction would represent a major advance for this population.

Sources Used On This Page

  1. 1
    eli-lilly-2024
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