Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial.

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From: The Lancet(Vol. 398, Issue 10295)
Publisher: Elsevier B.V.
Document Type: Article
Length: 610 words

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Summary Background Despite advancements in care, many people with type 2 diabetes do not meet treatment goals; thus, development of new therapies is needed. We aimed to assess efficacy, safety, and tolerability of novel dual glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist tirzepatide monotherapy versus placebo in people with type 2 diabetes inadequately controlled by diet and exercise alone. Methods We did a 40-week, double-blind, randomised, placebo-controlled, phase 3 trial (SURPASS-1), at 52 medical research centres and hospitals in India, Japan, Mexico, and the USA. Adult participants ([greater than or equal to]18 years) were included if they had type 2 diabetes inadequately controlled by diet and exercise alone and if they were naive to injectable diabetes therapy. Participants were randomly assigned (1:1:1:1) via computer-generated random sequence to once a week tirzepatide (5, 10, or 15 mg), or placebo. All participants, investigators, and the sponsor were masked to treatment assignment. The primary endpoint was the mean change in glycated haemoglobin (HbA.sub.1c) from baseline at 40 weeks. This study is registered with ClinicalTrials.gov, NCT03954834. Findings From June 3, 2019, to Oct 28, 2020, of 705 individuals assessed for eligibility, 478 (mean baseline HbA.sub.1c 7*9% [63 mmol/mol], age 54*1 years [SD 11*9], 231 [48%] women, diabetes duration 4*7 years, and body-mass index 31*9 kg/m.sup.2) were randomly assigned to tirzepatide 5 mg (n=121 [25%]), tirzepatide 10 mg (n=121 [25%]), tirzepatide 15 mg (n=121 [25%]), or placebo (n=115 [24%]). 66 (14%) participants discontinued the study drug and 50 (10%) discontinued the study prematurely. At 40 weeks, all tirzepatide doses were superior to placebo for changes from baseline in HbA.sub.1c, fasting serum glucose, bodyweight, and HbA.sub.1c targets of less than 7*0% ( Interpretation Tirzepatide showed robust improvements in glycaemic control and bodyweight, without increased risk of hypoglycaemia. The safety profile was consistent with GLP-1 receptor agonists, indicating a potential monotherapy use of tirzepatide for type 2 diabetes treatment. Funding Eli Lilly and Company. Author Affiliation: (a) Dallas Diabetes Research Center at Medical City, Dallas, TX, USA (b) MultiCare Rockwood Clinic, Spokane, WA, USA (c) National Research Institute, Los Angeles, CA, USA (d) Takatsuki Red Cross Hospital, Osaka, Japan (e) Eli Lilly and Company, Indianapolis, IN, USA * Correspondence to: Dr Julio Rosenstock, Dallas Diabetes Research Center at Medical City, Dallas, TX 75230, USA Byline: Julio Rosenstock, MD [juliorosenstock@dallasdiabetes.com] (a), Carol Wysham, MD (b), Juan P Frías, MD (c), Shizuka Kaneko, MD (d), Clare J Lee, MD (e), Laura Fernández Landó, MD (e), Huzhang Mao, PhD (e), Xuewei Cui, PhD (e), Chrisanthi A Karanikas, MS (e), Vivian T Thieu, PhD (e)

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Gale Document Number: GALE|A667906692