Once-Weekly Insulin Icodec vs. Once-Daily Insulin Glargine U100 for type 2 diabetes: a systematic review and meta-analysis of phase 2 randomized controlled trials

Silva, Rodrigo Ribeiro e; Gauza, Mateus de Miranda; Guisso, Maria Eduarda Schramm; Silva, Júlia Opolski Nunes da; Kohara, Suely Keiko

doi:10.20945/2359-3997000000614

Cited by 11 publications

(5 citation statements)

References 20 publications

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“…In this meta‐analysis, once‐weekly insulin icodec showed superiority with a higher HbA1c reduction in comparison with once‐daily basal insulin analogues. This result is similar to the meta‐analysis of phase 2 studies of once‐weekly insulin icodec ( p = .002) 18 . There was no significant difference with respect to the FPG between insulin icodec and the comparators, which is in par with previous phase 2 meta‐analysis 18 .…”

Section: Discussionsupporting

confidence: 86%

“…This result is similar to the meta‐analysis of phase 2 studies of once‐weekly insulin icodec ( p = .002) 18 . There was no significant difference with respect to the FPG between insulin icodec and the comparators, which is in par with previous phase 2 meta‐analysis 18 . The pooled analysis to estimate the proportion of patients achieving HbA1c <7% was superior with once‐weekly insulin icodec in comparison with the comparators.…”

Section: Discussionsupporting

confidence: 84%

“…The TIR (70‐180 mg/dl) and TBR <70 mg/dl was comparably similar with once‐weekly insulin icodec and comparators; however, TBR (<54 mg/dl) was higher in insulin icodec and TAR (>180 mg/dl) was higher for the comparator group. There was significantly great weight reduction with insulin icodec as compared with the comparators in this meta‐analysis, which was not similar when compared with the meta‐analysis of phase 2 18 . In addition, the total insulin dose ratio in the insulin icodec group was higher when compared with other insulin analogues.…”

Section: Discussioncontrasting

confidence: 64%

“…With respect to the incidence of hypoglycaemia, there was a higher incidence of level 1 hypoglycaemia with insulin icodec compared with the comparators, whereas there was no significant difference in clinically significant hypoglycaemia (level 2), severe hypoglycaemia (level 3) and combined (level 2/3) hypoglycaemia with once‐weekly insulin icodec in comparison with the once‐daily basal insulin analogues. The adverse events profile between insulin icodec and comparators was comparably similar with no statistically significant differences, akin to the adverse effect profile in phase 2 meta‐analysis 18 . There was no significant difference with respect to the rate of hypoglycaemia per patient‐year for level 1, level 2, level 3 and combined level 2/3 hypoglycaemia.…”

Section: Discussionmentioning

confidence: 59%

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Efficacy and safety of once‐weekly insulin icodec in type 2 diabetes: A meta‐analysis of ONWARDS phase 3 randomized controlled trials

Shetty,

Suvarna

2024

Diabetes Obesity Metabolism

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AimInsulin icodec is a novel ultra‐long action basal insulin analogue designed for once‐weekly administration. With the merit of once‐a‐week administration, it promises better adherence and greater treatment satisfaction because of reduced injection frequency. The purpose of this study was to ascertain the efficacy and safety of once‐weekly insulin icodec in comparison with other basal insulin analogues in the management of type 2 diabetes.Materials and MethodsThe PRISMA guidelines were followed during the conduct of this study. For the eligible studies, five databases and ClinicalTrials.gov were screened until July 2023. All randomized controlled trials comparing the efficacy and safety of insulin icodec in type 2 diabetes versus other insulin analogues were included. The extracted data were then analysed for meta‐analysis using RevMan 5.3 software.ResultsFive clinical trials with 3764 participants were included. The meta‐analysis showed that once‐weekly insulin icodec had higher glycated haemoglobin (HbA1c) reduction [mean difference −0.17%, 95% confidence interval (CI; −0.28 to −0.06), p = .003], with no significant difference in fasting plasma glucose compared with other insulin analogues. HbA1c achievement <7% [odds ratio 1.51, 95% CI (1.14‐1.99), p = .004] and HbA1c achievement <7% without hypoglycaemia [odds ratio 1.45, 95% CI (1.26‐1.67), p < .00001] were observed in higher proportions with insulin icodec compared with the comparator group. The percentage of time spent in the target glycaemic range was comparatively similar between insulin icodec and the comparator [mean difference 2.42%, 95% CI (0.01‐4.84), p = .05]. There was a significantly higher incidence of level 1 hypoglycaemia with insulin icodec but no significant difference was seen for the incidence of levels 2, 3 and combined 2/3 hypoglycaemia. Any adverse events and adverse events related to basal insulin were comparably similar in insulin icodec and comparators. The subgroup analysis of once‐weekly insulin icodec with individual insulin analogues (glargine U100 and degludec) showed that insulin icodec had similar efficacy with insulin glargine U100 but superior efficacy with higher HbA1c reduction with insulin icodec compared with insulin degludec. The safety profile was comparable between insulin icodec and glargine U100, whereas insulin icodec reported higher incidence of hypoglycaemia events and any adverse events when compared with degludec.ConclusionOnce‐weekly insulin icodec showed a better HbA1c reduction with a higher proportion of patients achieving HbA1c targets in comparison with once‐daily basal insulin analogues. They were no major safety concerns with respect to hypoglycaemia or adverse events.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 84%

Section: Discussioncontrasting

confidence: 64%

Section: Discussionmentioning

confidence: 59%

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Efficacy and safety of once‐weekly insulin icodec in type 2 diabetes: A meta‐analysis of ONWARDS phase 3 randomized controlled trials

Shetty,

Suvarna

2024

Diabetes Obesity Metabolism

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“…However, this meta-analysis included only 453 patients. [22] Our meta-analysis included the recently updated Phase 2 and III clinical trials involving a total of 2391 patients, and conducted a subgroup analysis to explore the impact of prior insulin-treated, insulin type, and treatment duration on the outcome. Therefore, our results are more reliable and instructive.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of once-weekly basal insulin versus once-daily basal insulin in patients with type 2 diabetes: A systematic review and meta-analysis

Wang,

Xiao,

Liang

et al. 2023

Medicine

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Background: Once-weekly insulin is expected to improve treatment compliance and durability and lead to better glycemic control. Several clinical trials on once-weekly insulin have recently been published. We conducted a systematic review and meta-analysis to investigate the efficacy and safety of once-weekly insulin versus once-daily insulin in type 2 diabetes (T2D). Methods: The following databases were searched for studies: PubMed, EMBASE, and Cochrane library (From January 1, 1946 to May 9, 2023). All randomized trials comparing weekly versus daily insulin in T2D were eligible for inclusion. Data analysis was performed using STATA 17.0 software (Stata Corporation, College Station, TX). The main outcomes and indexes included reduction in Hemoglobin A1c (HbA1c), fasting plasma glucose and bodyweight, proportion of patients achieving HbA1c < 7%, time-in-range 70 to 180 mg/dL and adverse events. Results: This systematic review and meta-analysis included 7 randomized controlled studies involving 2391 patients (1347 receiving 1-week insulin and 1044 receiving 1-day insulin). Once-weekly insulin was not inferior to once-daily insulin in HbA1c change [estimated treatment difference (ETD) = −0.05; 95% confidence intervals (CI): −0.14 to 0.04), HbA1c < 7% (odds ratio = 1.14; 95% CI: 0.87–1.50), fasting plasma glucose (ETD = 0.09; 95% CI: −0.19 to 0.36) and body weight loss (ETD = 0.27; 95% CI: −0.36 to 0.91). In terms of time-in-range 70 to 180 mg/dL, weekly insulin was superior to daily insulin (MTD = 3.84; 95% CI: 1.55–6.08). Icodec was associated with higher incidence of all adverse events (odds ratio = 1.20; 95% CI: 1.03–1.48; P = .024), but did not result in high risk of serious and severe adverse events. Moreover, icodec and Basal Insulin Fc did not result in higher incidence of hypoglycemia compared with insulin daily. Conclusion: Our meta-analysis found that insulin weekly was well tolerated and effective for glycemic control. Once-weekly insulin was not inferior to once-daily insulin in both efficacy and safety in T2D.

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Clinical Outcomes With Once‐Weekly Insulin Icodec Versus Once‐Daily Insulin Glargine U100 in Insulin‐Naïve and Previously Insulin‐Treated Individuals With Type 2 Diabetes: A Meta‐Analysis of Randomised Controlled Trials

Ahmed,

Shafiq,

Javaid

et al. 2024

Endocrino Diabet & Metabol

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AimsThe once‐weekly insulin icodec, a new basal insulin analog, may positively support a reduction in injection frequency and improve adherence to therapy in type 2 diabetes (T2D). This study aimed to evaluate the safety and efficacy of insulin icodec compared with those of once‐daily glargine U100.MethodsA comprehensive literature search was conducted using PubMed/MEDLINE, Embase and the Cochrane Library from inception till September 2023. Data about clinical outcomes in both groups were extracted. Forest plots were generated using the random‐effects model by pooling odds ratios (ORs) and mean differences (MDs).ResultsFive randomised controlled trials and 2019 individuals with T2DM were included. In the pooled analysis, time in range was significantly higher (MD = 4.35; 95% CI: 1.65 to 7.05; p = 0.002) in the icodec group than in the once‐daily glargine group. The HbA1c levels were significantly reduced (MD = −0.13; 95% CI: −0.24 to −0.03; p = 0.02) in the weekly icodec group compared with those in the once‐daily glargine group. The weight gain was significantly less in the glargine group than in the weekly icodec group (MD = 0.41; 95% CI: 0.04 to 0.78; p = 0.03); however, in the subgroup analysis, this change became statistically insignificant in both insulin‐naïve and previously insulin‐treated individuals. The results were comparable across two groups for fasting plasma glucose levels, hypoglycaemia alert (Level 1), clinically significant (Level 2) or severe hypoglycaemia (Level 3), and adverse events.ConclusionInsulin icodec was associated with a reduction in glycated haemoglobin levels and higher time in range, with a similar safety profile as compared to insulin glargine U100. However, further evidence is still needed to reach a definitive conclusion.

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Once-Weekly Insulin Icodec vs. Once-Daily Insulin Glargine U100 for type 2 diabetes: a systematic review and meta-analysis of phase 2 randomized controlled trials

Cited by 11 publications

References 20 publications

Efficacy and safety of once‐weekly insulin icodec in type 2 diabetes: A meta‐analysis of ONWARDS phase 3 randomized controlled trials

Efficacy and safety of once‐weekly insulin icodec in type 2 diabetes: A meta‐analysis of ONWARDS phase 3 randomized controlled trials

Efficacy and safety of once-weekly basal insulin versus once-daily basal insulin in patients with type 2 diabetes: A systematic review and meta-analysis

Clinical Outcomes With Once‐Weekly Insulin Icodec Versus Once‐Daily Insulin Glargine U100 in Insulin‐Naïve and Previously Insulin‐Treated Individuals With Type 2 Diabetes: A Meta‐Analysis of Randomised Controlled Trials

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