rDNA insulin glargine U300 &amp;ndash; a critical appraisal

Wang, Fei; Zassman, Stefanie; Goldberg, Philip A.

doi:10.2147/dmso.s87873

Cited by 11 publications

(9 citation statements)

References 43 publications

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“…As T2DM progresses, the need of patients for glycemic control gradually increases, and most patients eventually require insulin for glycemic control ( 44 ). Glargine is the first long-acting basal analog of insulin with superior glucose-lowering effects ( 45 , 46 ). But unfortunately, it increases the risk of weight gain and hypoglycemia ( 47 ), which are risk factors of T2DM, so the guidelines do not recommend insulin for all patients with T2DM ( 48 ).…”

Section: Discussionmentioning

confidence: 99%

Optimal dose of tirzepatide for type 2 diabetes mellitus: A meta-analysis and trial sequential analysis

Yin

et al. 2022

Front. Cardiovasc. Med.

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ObjectiveThe purpose of this study is to evaluate the optimal dose of tirzepatide (TZP) for the treatment of type 2 diabetes mellitus (T2DM) by meta-analysis and trial sequential analysis (TSA).MethodsClinical trials of TZP for T2DM were obtained by searching 8 databases with a time limit from database creation to May 2022. Mean differences (MD) and 95% confidence intervals (95%CI) were used for continuous variables, and relative risk (RR) and 95%CI were used for dichotomous variables.ResultsCompared with TZP 5 mg, meta-analysis showed that TZP 10 mg significantly reduced glycosylated hemoglobin type A1c (HbA1c) (MD −0.24, 95%CI −0.31~-0.17, P < 0.00001), fasting serum glucose (FSG) (MD −5.82, 95%CI −8.35~-3.28, P < 0.00001) and weight (MD −2.47, 95%CI −2.95~-1.98, P < 0.00001), and TZP 15 mg significantly reduced HbA1c (MD −0.37, 95%CI −0.44~-0.29, P < 0.00001), FSG (MD −8.52, 95%CI −11.07~-5.98, P < 0.00001) and weight (MD −4.63, 95%CI −5.45~-3.81, P < 0.00001). Compared with TZP 10 mg, TZP 15 mg dramatically reduced HbA1c (MD −0.12, 95%CI −0.19~-0.05, P = 0.001), FSG (MD −2.73, 95%CI −5.29~-0.17, P = 0.04) and weight (MD −2.18, 95%CI −2.67~-1.70, P < 0.00001). The TSA indicated that the benefits observed in the current information set were conclusive, except for the FSG of “TZP 15 mg vs. TZP 10 mg”. In terms of safety endpoints, meta-analysis revealed that there was no significant difference in the serious adverse events (AEs), major adverse cardiovascular events-4 (MACE-4), cardiovascular death, hypertension, cancer and hypoglycemic of the three dose groups of TZP. Compared with TZP 5 mg, TZP 10 mg increased total adverse events (RR 1.06, 95%CI 1.01~1.11, P = 0.03) and gastrointestinal (GI) AEs (RR 1.17, 95%CI 1.03~1.33, P = 0.02), and TZP 15 mg increased total AEs (RR 1.10, 95%CI 1.05~1.15, P = 0.0001). There were no significant differences in total AEs and GI AEs for TZP 15 mg compared to TZP 10 mg. The TSA demonstrated that the total AEs of “TZP 15 mg vs. TZP 5 mg” were conclusive.ConclusionsTZP 15 mg >TZP 10 mg > TZP 5 mg in terms of lowering glycemia and reducing weight. TZP 5 mg > TZP 10 mg = TZP 15 mg in terms of safety. On this basis, we recommend TZP 5 mg as the first-choice dose for patients with T2DM to minimize AEs while reducing glycemia and weight. If patients cannot effectively control their glycemia after taking TZP 5 mg, it is recommended to take TZP 15 mg directly to achieve the best effect of glycemic reduction. However, most of the included studies have the background of basic medication, the independent efficacy and safety of different doses of TZP still need to be tested.Systematic review registrationUnique Identifier: CRD42022341966.

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Section: Discussionmentioning

confidence: 99%

Optimal dose of tirzepatide for type 2 diabetes mellitus: A meta-analysis and trial sequential analysis

Yin

et al. 2022

Front. Cardiovasc. Med.

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“…Confirmed or severe nocturnal hypoglycemia was significantly lower in 1 study (16) but not in other shorter trials (15). Insulin glargine U-300 may require a higher dose than insulin glargine U-100 and may result in less weight gain (15,17).…”

Section: Basal Insulin and Basal-bolus Injection Therapymentioning

confidence: 90%

Glycemic Management in Adults With Type 1 Diabetes

McGibbon¹,

Adams²,

Ingersoll³

et al. 2018

Canadian Journal of Diabetes

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“…A pertinent observation was of a difference in dose requirement of basal insulin that was both statistically and clinically significant and in favour of Gla‐100 over Gla‐300, for both the T1D and T2D populations. Both RCTs and real‐world evidence (RWE) studies have shown that the basal insulin doses for Gla‐300 needed to achieve equivalent glycaemic control were 10%‐20% higher than for Gla‐100 in T1D and T2D patients 8,12,18,21,26‐29 . This difference is more pronounced in insulin‐naïve populations treated with Gla‐300 or Gla‐100.…”

Section: Discussionmentioning

confidence: 99%

Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: A systematic literature review and meta‐analysis

Joshi

Singh

Marwah

et al. 2023

Diabetes Obesity Metabolism

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Aim: To compare the clinical efficacy and safety of glargine-U100 (Lantus/Gla-100) with glargine-U300 (Toujeo/Gla-300) in adult patients with type 2 diabetes (T2D) and type 1 diabetes (T1D). Materials and Methods:A literature search on Gla-300/Gla-100 in diabetes management was conducted using the MEDLINE/Embase/Cochrane databases from inception to 10 January 2021. Eligible studies considered for inclusion were paralleldesign, randomized controlled trials (RCTs). The Cochrane risk-of-bias tool was used to evaluate the quality of the included studies. The random-effects model was applied for interpretation of the results.Results: Of 5348 records screened, 592 were assessed for eligibility and 15 RCTs were considered for data extraction and meta-analysis (T2D [N = 10; n = 7082]; T1D [N = 5; n = 2222]). In patients with T1D, all safety parameters were comparable between Gla-100 and Gla-300. In T2D, statistically significant differences were observed in favour of Gla-300 over Gla-100 for nocturnal and total hypoglycaemia.For efficacy parameters, a statistically and clinically significant difference favouring Gla-100 in basal insulin dose requirement was observed for both T2D and T1D.Change in HbA1c showed a statistically but not clinically significant reduction with Gla-100 compared with Gla-300 in T1D. Statistically significant but clinically less relevant differences favoured Gla-300 for control of body weight in T1D and T2D and Gla-100 for fasting blood glucose in T2D.Conclusions: Gla-100 and Gla-300 had comparable efficacy and safety profiles in both T1D and T2D populations. Gla-300 showed a lower risk of nocturnal and total hypoglycaemia, significant in insulin-experienced/exposed patients with T2D.Patients on Gla-300 required significantly more units of insulin daily than the Gla-100 group to achieve equivalent efficacy.

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rDNA insulin glargine U300 – a critical appraisal

Cited by 11 publications

References 43 publications

Optimal dose of tirzepatide for type 2 diabetes mellitus: A meta-analysis and trial sequential analysis

Optimal dose of tirzepatide for type 2 diabetes mellitus: A meta-analysis and trial sequential analysis

Glycemic Management in Adults With Type 1 Diabetes

Comparative clinical efficacy and safety of insulin glargine 300 U/ml (Toujeo) versus insulin glargine 100 U/ml in type 2 diabetes and type 1 diabetes: A systematic literature review and meta‐analysis

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