Lilly's Dual GIP/GLP-1 Receptor Agonist Tirzepatide Demonstrates Significant Glycemic and Weight Control in Type 2 Diabetes Patients: SURPASS-5 Phase 3 Data Published in JAMA

News on February 12, 2022 /BioValleyBIOON/ -- According to data from a Phase 3 clinical study (SURPASS-5) recently published in the Journal of the American Medical Association (JAMA):Type 2 diabetes patients receiving titrated insulin glargine therapy but with inadequate blood glucose controlDiabetesIn patients, titration of insulin glargine + subcutaneous injection of tirzepatide (LY3298176) significantly improved glycemic control and reduced body weight.See details:Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes：The SURPASS-5 Randomized Clinical Trial。

Tirzepatide (LY3298176) is developed byEli LillyA novel once-weekly dual agonist of glucose-dependent insulinotropic polypeptide (GIP, also known as gastric inhibitory polypeptide) receptor and glucagon-like peptide-1 (GLP-1) receptor. Both GIP and GLP-1 are gut-secreted hormones that can promote insulin secretion.

Tirzepatide integrates two insulinotropic actions into a single molecule, representing a treatment for type 2DiabetesA new class of drugs.In addition, tirzepatide is also being developed for weight management, for the treatment of heart failure with preserved ejection fraction (HFpEF), and as a potential treatment for nonalcoholic steatohepatitis (NASH).

Currently, tirzepatide treats type 2DiabetesThe New Drug Application (NDA) for adult patients is currently under review by the U.S. FDA, with approval results expected in May 2022. Notably, inFDAAt the same time of NDA submission,Eli LillyA Priority Review Voucher (PRV) was also submitted to expedite the NDA review. In addition, tirzepatide is currently under review by the European Medicines Agency (EMA).

SURPASS-5 is a 40-week randomized, double-blind trial in people with type 2 diabetes who have inadequate blood sugar control on titrated insulin glargine (with or without metformin).DiabetesThe study was conducted in patients, comparing the efficacy and safety of three doses (5mg, 10mg, 15mg) of tirzepatide (once weekly, subcutaneous injection) as an add-on therapy versus placebo. The enrolled patients had an average diabetes duration of 13.3 years, a baseline A1C of 8.31%, a baseline weight of 95.2 kg, and a baseline insulin glargine dose of 37.6 units/day.

In this study, two types of estimands (Efficacy Estimand and Treatment-Regimen Estimand) were used to compare treatment differences. The Efficacy Estimand refers to the efficacy before discontinuation of the study drug or initiation of rescue therapy for persistent severe hyperglycemia. The Treatment-Regimen Estimand refers to the efficacy regardless of whether the study drug is continued or whether rescue therapy is used for persistent severe hyperglycemia.

The results showed that, with two kinds of estimation methods, the study reached the primary endpoint and key secondary endpoint:All three doses of tirzepatide showed better effects in lowering blood glucose (A1C) and reducing body weight compared to placebo.Among patients treated with three doses of tirzepatide, 85-90% achieved A1C <7% (the treatment goal for diabetes patients recommended by the American Diabetes Association [ADA]), compared to 34% in the placebo group (all p<0.001).

Compared with the placebo group, the most common treatment-related adverse events in the tirzepatide group were diarrhea (12%-21% vs 10%) and nausea (13%-18% vs 3%). (Bioon.com)

Source of Original Text:Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes：The SURPASS-5 Randomized Clinical Trial