Tirzepatide Associated With Improved Health-Related Quality of Life in Adults With Obesity or Overweight in SURMOUNT-4.

Objective: In SURMOUNT-4, participants with obesity or overweight regained substantial weight after tirzepatide withdrawal, whereas continued treatment resulted in additional weight reduction. We evaluated the effect of continued tirzepatide treatment on health-related quality of life (HRQoL) in SURMOUNT-4.

Methods: Participants who achieved tirzepatide maximum tolerated dose (MTD; 10 or 15 mg; N = 670) during a 36-week (W) lead-in period were randomized (1:1) to continue receiving tirzepatide MTD or switch to placebo through W88.

Early-Onset Obesity and Tirzepatide Treatment: A Post Hoc Analysis of the SURMOUNT Clinical Trials.

Objective: People with early-onset obesity (diagnosed at age < 25 years) may present with more cardiometabolic abnormalities and obesity-related complications. This post hoc analysis assessed baseline characteristics and body weight (BW) changes with tirzepatide in people with early- versus later-onset obesity.

Methods: Participants (N = 3782) from SURMOUNT-1, SURMOUNT-3, and SURMOUNT-4 randomized to tirzepatide or placebo were included.

Weight reduction over time in tirzepatide-treated participants by early weight loss response: Post hoc analysis in SURMOUNT-1.

Aims: The objective was to assess weight reduction at Weeks 24 and 72 in participants treated with tirzepatide based on weight reduction response after 12 weeks of treatment in the SURMOUNT-1 trial.

Materials And Methods: This post hoc analysis included participants treated with tirzepatide who received ≥75% of the assigned treatment doses and had weight measurements at Weeks 0, 12, 24 and 72. Participants were categorized based on the 12-week response to tirzepatide: late responders (<5% weight reduction at Week 12) or early responders (≥5% weight reduction at Week 12).

Tirzepatide and health-related quality of life in adults with obesity or overweight: Results from the SURMOUNT-3 phase 3 randomized trial.

Aims: Tirzepatide reduced weight significantly more than placebo in adults with obesity/overweight who had already achieved ≥5% weight reduction with a 12-week intensive lifestyle intervention (randomized population) in SURMOUNT-3, a phase 3, 72-week, randomized, double-blind clinical trial. This analysis evaluated health-related quality of life (HRQoL) with tirzepatide versus placebo treatment in the SURMOUNT-3 randomized population and selected subgroups.

Materials And Methods: The randomized population received placebo (N = 292) or tirzepatide maximum tolerated dose (N = 287) for 72 weeks.

Tirzepatide Was Associated with Improved Health-Related Quality of Life in Adults with Obesity or Overweight and Type 2 Diabetes: Results from the Phase 3 SURMOUNT-2 Trial.

Introduction: In SURMOUNT-2, a phase 3, randomized clinical trial, tirzepatide treatment resulted in clinically meaningful reduction in bodyweight among people with obesity or overweight and T2D. The current analysis evaluated the effects of tirzepatide treatment on self-reported health-related quality of life (HRQoL) outcomes among SURMOUNT-2 participants.

Methods: SURMOUNT-2 participants were randomly assigned (1:1:1) to receive either tirzepatide 10 mg (n = 312), tirzepatide 15 mg (n = 311), or placebo (n = 315) for 72 weeks as an adjunct to diet and exercise.

Body composition changes during weight reduction with tirzepatide in the SURMOUNT-1 study of adults with obesity or overweight.

Aims: We assessed changes in body composition following tirzepatide treatment in a substudy of participants with obesity or overweight from the SURMOUNT-1 trial, overall and post hoc in clinically relevant subgroups.

Materials And Methods: Substudy participants (n = 160 of the 2539 in SURMOUNT-1) underwent dual-energy X-ray absorptiometry (DXA) at baseline and Week 72. Body composition parameters were evaluated by analysis of covariance, logistic regression or Fisher's exact test.

Time to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials.

The rate of weight reduction during obesity treatment declines over time and eventually reaches a weight plateau. We investigated factors associated with time to weight plateau (TTWP) in tirzepatide-treated participants with obesity or overweight in a post-hoc analysis of SURMOUNT-1 and SURMOUNT-4 trials. Participants adherent to tirzepatide treatment and achieving ≥5% weight loss by primary endpoint (week 72 SURMOUNT-1; week 88 SURMOUNT-4) were included.

Gastrointestinal tolerability and weight reduction associated with tirzepatide in adults with obesity or overweight with and without type 2 diabetes in the SURMOUNT-1 to -4 trials.

Aims: This analysis evaluated whether gastrointestinal (GI) adverse events (AEs) including nausea, vomiting, diarrhoea (N/V/D) and dyspepsia were associated with weight reduction with tirzepatide across the SURMOUNT-1 to -4 trials.

Materials And Methods: SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D). Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.

Key Strategies for Overcoming Psychological Insulin Resistance in Adults with Type 2 Diabetes: The UK Subgroup in the EMOTION Study.

Introduction: Many patients with type 2 diabetes mellitus (T2DM) delay initiation of insulin therapy despite healthcare professional (HCP) advice. This phenomenon has been referred to as 'psychological insulin resistance' (PIR), and various contributing factors have been identified. Studies discussing approaches to overcoming PIR are lacking.

Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26-week PRONTO-T1D study.

Aims: To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26-week, treat-to-target, phase 3 trial.

Materials And Methods: After an 8-week lead-in to optimize basal insulin glargine or degludec, patients were randomized to double-blind mealtime URLi (n = 451) or lispro (n = 442), or open-label post-meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non-inferiority margin 0.

Ultra-Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Substudy.

This study evaluated glucose control by continuous glucose monitoring (CGM) during treatment with ultra-rapid lispro (URLi) or lispro used in combination with insulin glargine or degludec in adults with type 1 diabetes in a substudy of the PRONTO-T1D study. Ambulatory glucose profiles were evaluated in 269 patients from PRONTO-T1D assigned to double-blind URLi ( = 97) or lispro ( = 99) given 0-2 min before the start of the meal (mealtime), or open-label URLi ( = 73) given 20 min after the meal (postmeal URLi). Blinded CGM was used for up to 14 days before baseline and the 26-week primary endpoint.

Key factors for overcoming psychological insulin resistance: an examination of patient perspectives through content analysis.

Objective: To understand participant perceptions about insulin and identify key behaviors of healthcare professionals (HCPs) that motivated initially reluctant adults from seven countries (n=40) who had type 2 diabetes (T2D) to start insulin treatment.

Research Design And Methods: Telephone interviews were conducted with a subset of participants from an international investigation of adults with T2D who were reluctant to start insulin (EMOTION). Questions related to: (a) participants' thoughts about insulin before and after initiation; (b) reasons behind responses on the survey that were either 'not helpful at all' or 'helped a lot'; (c) actions their HCP may have taken to help start insulin treatment; and (d) advice they would give to others in a similar situation of starting insulin.

Basal insulin persistence in Brazilian participants with T2DM.

Objective: Real-world effectiveness of basal insulin therapy is affected by poor treatment persistence, often occurring soon after initiation. This analysis is part of an international cross-sectional study conducted in T2DM patients and is intended to describe the reasons behind non-persistence to insulin therapy in Brasil.

Methods: Responders to an online survey in seven countries were classified as continuers (no gap of ≥7 days), interrupters (interrupted therapy for ≥7 days within first 6 months, then restarted), and discontinuers (terminated therapy for ≥7 days within first 6 months, and did not start it again before the survey).

Identifying solutions to psychological insulin resistance: An international study.

Aims: To identify actions of healthcare professionals (HCPs) that facilitate the transition to insulin therapy (IT) in type 2 diabetes (T2D) adults.

Methods: Included were T2Ds in seven countries (n = 594) who reported initial IT reluctance but eventually began IT. An online survey included 38 possible HCP actions: T2Ds indicated which may have occurred and their helpfulness.

Associated factors that influenced persistence with basal analog insulin therapy among people with type 2 diabetes: An exploratory analysis from a UK real-world sample.

Aim: Real-world effectiveness of insulin therapy is affected by poor treatment persistence, often occurring soon after initiation. An international cross-sectional survey of people with type 2 diabetes mellitus (T2DM) has been conducted to describe reasons for non-persistence with insulin therapy.

Methods: Responders to an online survey in 7 countries were classified as continuers (no gap of ≥7days), interrupters (interrupted therapy for ≥7days within first 6 months, then restarted), and discontinuers (terminated therapy for ≥7days within first 6 months, no restart before survey).

Insulin non-persistence among people with type 2 diabetes: how to get your patients to stay on insulin therapy.

Continuing use of medication is key to effective treatment and positive health outcomes, particularly in chronic conditions such as diabetes. However, in primary care, non-persistence (i.e.

Identifying insulin treatment responders with a composite measure: beyond Hba1c < 7% in patients with type 2 diabetes.

Objectives: Many insulin-treated patients with type 2 diabetes (T2D) do not reach hemoglobin A1c (HbA1c) < 7%, but have clinically relevant HbA1c reductions. Using an integrated database (IDB) of 53 insulin lispro clinical trials and a real-world evidence (RWE) database of T2D patients initiating insulin therapy, an expanded HbA1c measure was used to identify responders to insulin therapy.

Methods: Analysis included 4,908 patients (IDB) and 1,134 patients (RWE) with T2D treated with any insulin regimen with a baseline and ≥1 post-baseline HbA1c.

Initiation of Basal Insulin Analog Treatment for Type 2 Diabetes and Reasons Behind Patients' Treatment Persistence Behavior: Real-World Data from Germany.

Background: Poor treatment persistence can affect the real-world effectiveness of insulin therapy. A cross-sectional online survey in 942 patients with type 2 diabetes from 7 different countries evaluated patient experience when initiating basal insulin and the reasons behind insulin persistence patterns. Here, we report the quantitative results for the subset of patients from Germany.

Correlates of basal insulin persistence among insulin-naïve people with type 2 diabetes: results from a multinational survey.

Background And Objective: People with T2DM who initiate basal insulin therapy often stop therapy temporarily or permanently soon after initiation. This study analyzes the reasons for and correlates of stopping and restarting basal insulin therapy among people with T2DM.

Methods: An online survey was completed by 942 insulin-naïve adults with self-reported T2DM from Brazil, France, Germany, Japan, Spain, UK, and US.

Basal insulin initiation use and experience among people with type 2 diabetes mellitus with different patterns of persistence: results from a multi-national survey.

Background And Objective: People with type 2 diabetes mellitus (T2DM) often interrupt basal insulin treatment soon after initiation. This study aimed to describe the experiences during and after basal insulin initiation among people with T2DM with different persistence patterns.

Methods: Adults with T2DM from France, Germany, Spain, UK, US, Brazil, and Japan were identified from consumer panels for an online survey.

Basal Insulin Persistence, Associated Factors, and Outcomes After Treatment Initiation: A Retrospective Database Study Among People with Type 2 Diabetes Mellitus in Japan.

Introduction: The objective of this study was to assess basal insulin persistence, associated factors, and economic outcomes for insulin-naïve people with type 2 diabetes mellitus (T2DM) in Japan.

Methods: People aged at least 18 years with T2DM with first claim for basal insulin between May 2006 and April 2013 (index date), no insulin use before index date, and continuous insurance coverage for 6 months before (baseline) and 12 months after index date were selected from the Japan Medical Center Database. On the basis of whether there were at least 30-day gaps in basal insulin treatment, patients were classified as continuers (no gap), interrupters (at least one prescription after gap), and discontinuers (no prescription after gap).

Basal insulin persistence, associated factors, and outcomes after treatment initiation among people with type 2 diabetes mellitus in the US.

Objective: To assess basal insulin persistence, associated factors, and economic outcomes for insulin-naïve people with type 2 diabetes mellitus (T2DM) in the US.

Research Design And Methods: People aged ≥18 years diagnosed with T2DM initiating basal insulin between April 2006 and March 2012 (index date), no prior insulin use, and continuous insurance coverage for 6 months before (baseline) and 24 months after index date (follow-up period) were selected using de-identified administrative claims data in the US. Based on whether there were ≥30 day gaps in basal insulin use in the first year post-index, patients were classified as continuers (no gap), interrupters (≥1 prescription after gap), and discontinuers (no prescription after gap).