Adherence to app-based dose guidance for once-weekly insulin icodec in insulin-naive individuals with type 2 diabetes: Post hoc analysis of ONWARDS 5.

Aims: In ONWARDS 5 (NCT04760626), a 52-week, Phase 3a trial in insulin-naive type 2 diabetes, 542/1085 participants were randomized to once-weekly insulin icodec with a dosing guide app to assist titration (icodec with app). This post hoc analysis of the icodec with app group assessed titration behaviours and associations between app-based dose guidance adherence and outcomes.

Materials And Methods: App-based dose guidance and manual overrides were assessed.

Continuous glucose monitoring in noninsulin-treated type 2 diabetes: A critical review of reported trials with an updated systematic review and meta-analysis of randomised controlled trials.

Aims: We aimed to review the observational and randomised clinical trial evidence and provide pragmatic recommendations for using continuous glucose monitoring (CGM) in individuals living with noninsulin-treated type 2 diabetes (T2DM).

Materials And Methods: We first undertook a narrative review of observational studies that enrolled noninsulin-users or mixed populations of noninsulin and insulin-users with T2DM as well as randomised controlled trials (RCTs) that enrolled mixed populations with T2DM. We then performed a systematic review of the RCTs that specifically enrolled noninsulin-treated populations with T2DM and compared CGM to BGM/usual care.

Discrete Choice Experiments and Conjoint Analyses in Health Screening Programs for Type 2 Diabetes and Liver Disease: A Scoping Review.

Background: We aimed to summarize the evidence on the use of discrete choice experiments (DCEs) and conjoint analyses to quantify stakeholders' preferences for screening programs for type 2 diabetes (T2D) and liver diseases, with a specific focus on metabolic dysfunction-associated steatotic liver disease (MASLD).

Methods: For this scoping review, five databases (MEDLINE [PubMed], PubMed Central, EMBASE [Ovid], Europe PMC, Google Scholar) were searched with the assistance of a librarian, and deduplicated records were screened by two independent reviewers. Inclusion criteria: using DCE/CA, addressing screening programs for T2D and liver disease, published in English, French, or Spanish after January 1990.

Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes.

Background: Cagrilintide and semaglutide have each been shown to induce weight loss as monotherapies. Data are needed on the coadministration of cagrilintide and semaglutide (called CagriSema) for weight management in adults with type 2 diabetes, including those in a subgroup who are undergoing continuous glucose monitoring.

Methods: In this phase 3a, double-blind, randomized, placebo-controlled trial conducted in 12 countries, we assigned adults with a body-mass index of 27 or more, a glycated hemoglobin level of 7 to 10%, and type 2 diabetes in a 3:1 ratio to receive once-weekly cagrilintide-semaglutide (2.

Oral Semaglutide and Cardiovascular Outcomes in People With Type 2 Diabetes, According to SGLT2i Use: Prespecified Analyses of the SOUL Randomized Trial.

Background: Both GLP-1 (glucagon-like peptide-1) receptor agonists and SGLT2 (sodium-glucose cotransporter-2) inhibitors (SGLT2i) improve cardiovascular outcomes in people with type 2 diabetes and cardiovascular or chronic kidney disease. However, there are limited data about the effect of combining these agents on cardiovascular and safety outcomes.

Methods: The SOUL trial (Semaglutide Cardiovascular Outcomes Trial; NCT03914326) randomized 9650 participants with type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease to oral semaglutide or placebo.

Efficacy and hypoglycaemia outcomes with once-weekly insulin icodec versus once-daily basal insulin in individuals with type 2 diabetes by kidney function: A post hoc participant-level analysis of the ONWARDS 1-5 trials.

Aim: This post hoc analysis of ONWARDS 1-5 assessed the efficacy and hypoglycaemia outcomes with once-weekly insulin icodec (icodec) versus once-daily basal insulin comparators (degludec, glargine U100 or glargine U300) in insulin-naive (ONWARDS 1, 3 and 5) and insulin-experienced (ONWARDS 2 and 4) adults (aged ≥18 years) with type 2 diabetes (T2D) by kidney function subgroup.

Materials And Methods: Treatment outcomes were analysed by trial according to kidney function subgroup (estimated glomerular filtration rate [eGFR] ≥90; eGFR 60-<90; eGFR 30-<60; eGFR <30; all mL/min/1.73m).

Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment.

Background: Insulin efsitora alfa (efsitora) is a new basal insulin designed for once-weekly administration. Data on safety and efficacy have been limited to small, phase 1 or phase 2 trials.

Methods: We conducted a 52-week, phase 3, parallel-design, open-label, treat-to-target trial involving adults with type 2 diabetes who had not previously received insulin.

Once-weekly insulin icodec compared with daily basal insulin analogues in type 2 diabetes: Participant-level meta-analysis of the ONWARDS 1-5 trials.

Aim: To perform a participant-level post hoc meta-analysis of Phase 3a trials in type 2 diabetes (T2D) to characterize the hypoglycaemia safety and glycaemic efficacy of once-weekly insulin icodec (icodec).

Materials And Methods: All ONWARDS 1-5 randomized participants were pooled as overall T2D, insulin-naive, an insulin-experienced subgroups, and by once-daily trial comparator (degludec or glargine U100). The main outcomes included incidence and rates of clinically significant and severe hypoglycaemia.

Clinical perspectives on the frequency of hypoglycemia in treat-to-target randomized controlled trials comparing basal insulin analogs in type 2 diabetes: a narrative review.

The objective of this review was to comprehensively present and summarize trends in reported rates of hypoglycemia with one or two times per day basal insulin analogs in individuals with type 2 diabetes to help address and contextualize the emerging theoretical concern of increased hypoglycemic risk with once-weekly basal insulins.Hypoglycemia data were extracted from treat-to-target randomized clinical trials conducted during 2000-2022. Published articles were identified on PubMed or within the US Food and Drug Administration submission documents.

Continuous Glucose Monitoring-Based Metrics and Hypoglycemia Duration in Insulin-Experienced Individuals With Long-standing Type 2 Diabetes Switched From a Daily Basal Insulin to Once-Weekly Insulin Icodec: Post Hoc Analysis of ONWARDS 2 and ONWARDS 4.

Objective: This post hoc analysis assessed continuous glucose monitoring (CGM)-based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4).

Research Design And Methods: Time in range (TIR) (3.9-10.

Primary and Secondary Cardiovascular and Kidney Prevention With Canagliflozin: Insights From the CANVAS Program and CREDENCE Trial.

Background: This study evaluated the effects of canagliflozin in patients with type 2 diabetes with and without prevalent cardiovascular disease (secondary and primary prevention).

Methods And Results: This was a pooled participant-level analysis of the CANVAS (Canagliflozin Cardiovascular Assessment Study) Program and CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) trial. The CANVAS Program included participants with type 2 diabetes at elevated cardiovascular risk, whereas the CREDENCE trial included participants with type 2 diabetes and albuminuric chronic kidney disease.

Gastrointestinal adverse events and weight reduction in people with type 2 diabetes treated with tirzepatide in the SURPASS clinical trials.

Aims: To evaluate gastrointestinal adverse events (AEs) and the impact of nausea, vomiting or diarrhoea (N/V/D) and any gastrointestinal (GI) AEs overall on weight change with tirzepatide across the SURPASS-1 to -5 clinical trials.

Materials And Methods: Participants with type 2 diabetes were randomized to receive once-weekly tirzepatide (5, 10 or 15 mg) or comparator (placebo, semaglutide 1 mg once weekly, or titrated daily basal insulins) as monotherapy or added on to background antihyperglycaemic medication(s). This post hoc analysis subdivided participants within each trial into subgroups that self-reported (yes/no) any N/V/D or GI AEs.

Once-Weekly Insulin Icodec With Dosing Guide App Versus Once-Daily Basal Insulin Analogues in Insulin-Naive Type 2 Diabetes (ONWARDS 5) : A Randomized Trial.

Background: Inadequate dose titration and poor adherence to basal insulin can lead to suboptimal glycemic control in persons with type 2 diabetes (T2D). Once-weekly insulin icodec (icodec) is a basal insulin analogue that is in development and is aimed at reducing treatment burden.

Objective: To compare the effectiveness and safety of icodec titrated with a dosing guide app (icodec with app) versus once-daily basal insulin analogues (OD analogues) dosed per standard practice.

Insulin Icodec Weekly: A Basal Insulin Analogue for Type 2 Diabetes.

Insulin icodec is a once-weekly basal insulin analogue in late-phase clinical development. Similar efficacy and safety of icodec to once-daily basal insulin analogues have been reported in over 4,200 participants with type 2 diabetes from three phase II and five phase III trials. Indeed, glycated haemoglobin reduction was superior for icodec among insulin-naïve participants (ONWARDS 1, 3 and 5) and in those switching from a daily basal insulin in ONWARDS 2, with the latter trial demonstrating improved diabetes treatment satisfaction scores with insulin icodec versus insulin degludec.