Diabetologia · 2025
Effects of insulin regimens for type 2 diabetes mellitus: a systematic review and network meta-analysis.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод в очереди
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Bertuol Vanderlei C, Iorra Fernando, Vieceli Tarsila, Tonolli Nicole T, Zappelini Roberta, van der Sand Luiza, Leitão Cristiane B, Rados Dimitris V
Аннотация
AIMS/HYPOTHESIS: Insulin therapy is essential for managing hyperglycaemia in type 2 diabetes mellitus when oral or non-insulin injectable agents are no longer effective. However, the comparative effectiveness and safety of different insulin regimens remain uncertain. We aimed to compare the effects of basal, basal-bolus, biphasic and prandial insulin regimens on glycaemic management, weight, severe hypoglycaemia, insulin dose and quality of life in adults with type 2 diabetes.
METHODS: We conducted a systematic review and network meta-analysis of RCTs. PubMed, EMBASE, the Cochrane Library and ClinicalTrials.gov were searched through to September 2025. The inclusion criteria for studies were RCTs enrolling adults with type 2 diabetes that compared at least two of the specified insulin regimens over ≥12 weeks. Pairs of reviewers independently screened studies, extracted data and assessed risk of bias using the Cochrane RoB-2 tool. Network meta-analyses were performed using a frequentist random-effects model, with basal insulin as the reference.
RESULTS: Fifty-eight RCTs involving 19,122 participants were included. Compared with basal insulin, HbA1c reduction was -3.4 mmol/mol (95% CI -4.9, -1.9 mmol/mol) (-0.31% [95% CI -0.45%, -0.17%]) with a basal-bolus insulin regimen, -2.7 mmol/mol (95% CI -3.7, -1.6 mmol/mol) (-0.24% [95% CI -0.34%, -0.15%]) with biphasic insulin and -4.1 mmol/mol (95% CI -6.2, -2.1 mmol/mol) (-0.38% [95% CI -0.57%, -0.19%]) with prandial insulin. These results were classified as being of moderate confidence due to incoherence. All regimens were associated with approximately 30% increased probability of achieving HbA1c target, 1 kg greater weight gain, and a borderline increase in the risk of severe hypoglycaemia. Insulin doses were slightly higher with basal-bolus and biphasic regimens. Quality-of-life data were limited. Subgroup analyses for insulin initiation and intensification yielded consistent results.
CONCLUSIONS/INTERPRETATION: Complex insulin regimens provide modest glycaemic benefits over basal insulin but are associated with greater weight gain and a suggested higher risk of hypoglycaemia. These results are based on evidence of moderate confidence. These trade-offs support the need for individualised regimen selection, informed by clinical context, patient preferences and treatment goals.
TRIAL REGISTRATION: PROSPERO registration no. CRD42020181473.
FUNDING: This research was supported by the Committee for the Development of Higher Education Personnel (CAPES) and the Hospital de Clínicas de Porto Alegre - FIPE HCPA.
METHODS: We conducted a systematic review and network meta-analysis of RCTs. PubMed, EMBASE, the Cochrane Library and ClinicalTrials.gov were searched through to September 2025. The inclusion criteria for studies were RCTs enrolling adults with type 2 diabetes that compared at least two of the specified insulin regimens over ≥12 weeks. Pairs of reviewers independently screened studies, extracted data and assessed risk of bias using the Cochrane RoB-2 tool. Network meta-analyses were performed using a frequentist random-effects model, with basal insulin as the reference.
RESULTS: Fifty-eight RCTs involving 19,122 participants were included. Compared with basal insulin, HbA1c reduction was -3.4 mmol/mol (95% CI -4.9, -1.9 mmol/mol) (-0.31% [95% CI -0.45%, -0.17%]) with a basal-bolus insulin regimen, -2.7 mmol/mol (95% CI -3.7, -1.6 mmol/mol) (-0.24% [95% CI -0.34%, -0.15%]) with biphasic insulin and -4.1 mmol/mol (95% CI -6.2, -2.1 mmol/mol) (-0.38% [95% CI -0.57%, -0.19%]) with prandial insulin. These results were classified as being of moderate confidence due to incoherence. All regimens were associated with approximately 30% increased probability of achieving HbA1c target, 1 kg greater weight gain, and a borderline increase in the risk of severe hypoglycaemia. Insulin doses were slightly higher with basal-bolus and biphasic regimens. Quality-of-life data were limited. Subgroup analyses for insulin initiation and intensification yielded consistent results.
CONCLUSIONS/INTERPRETATION: Complex insulin regimens provide modest glycaemic benefits over basal insulin but are associated with greater weight gain and a suggested higher risk of hypoglycaemia. These results are based on evidence of moderate confidence. These trade-offs support the need for individualised regimen selection, informed by clinical context, patient preferences and treatment goals.
TRIAL REGISTRATION: PROSPERO registration no. CRD42020181473.
FUNDING: This research was supported by the Committee for the Development of Higher Education Personnel (CAPES) and the Hospital de Clínicas de Porto Alegre - FIPE HCPA.