The SURPASS-AP-Combo trial shows that addition of tirzepatide as 2L or 3L therapy is non-inferior & superior to insulin glargine for glycemic outcomes at 40 weeks in an Asia-Pacific (mostly Chinese) population w/ type 2 diabetes.
= 6) and India . The study consisted of a 1-week screening period, a 2-week lead-in period, a 40-week treatment period and a 4-week safety follow-up period .Patients were recruited and enrolled at the 66 study sites by investigators and randomly assigned 1:1:1:1 to tirzepatide 5 mg, 10 mg, 15 mg or insulin glargine using a computer-generated randomization sequence, which was implemented via an interactive web-response system .
Insulin glargine was administered once daily at bedtime by subcutaneous injection using a pre-filled pen. The starting dose was 6 IU d, which was then titrated using a treat-to-target algorithm to reach the fasting blood glucose target of 4.0–5.6 mmol LAll patients continued background therapy with metformin, with or without a sulphonylurea, at the same pre-study dose. Patients with severe, persistent hyperglycemia meeting pre-defined criteria could initiate rescue antihyperglycemic therapy.
Safety endpoints included the incidence of TEAEs, serious AEs and discontinuation of study treatment due to AEs. AEs of special interest included hypoglycemia, severe persistent hyperglycemia, thyroid safety, gastrointestinal disorders, diabetic retinopathy, MACE-4, allergic/hypersensitivity reactions and adjudicated pancreatic AEs. An independent committee adjudicated pancreatic AEs and MACE-4. Further safety endpoints included change from baseline in vital signs .
HbA1c was analyzed using Bio-Rad Variant II. FSG, lipids, pancreatic amylase, lipase and hepatic enzymes were analyzed using Roche Cobas C501. All of these tests were performed by central laboratories . Weight and waist circumference were measured at fasting visits.This study was designed to randomly assign patients to tirzepatide 5 mg, 10 mg or 15 mg or insulin glargine, respectively. The sample size calculation assumed at least a 0.
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