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Assessing the risk of ketoacidosis due to sodium-glucose cotransporter (SGLT)-2 inhibitors in patients with type 1 diabetes: A meta-analysis and meta-regression

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Musso, Giovanni, Sircana, Antonio, Saba, Francesca, Cassader, Maurizio, Gambino, Roberto·2020·PLOS Medicine
DOI 10.1371/journal.pmed.1003461PMC PMC7771708
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Abstract

Background: Sodium-glucose cotransporter-2 (SGLT2) inhibitors (SGLT2i) showed benefits in type 1 diabetes mellitus (T1DM), but the risk of diabetic ketoacidosis (DKA) limits their use. Ability to predict DKA risk and therapeutic responses would enable appropriate patient selection for SGLT2i. We conducted a meta-analysis and meta-regression of randomized controlled trials (RCTs) evaluating SGLT2i in T1DM to assess moderators of the relative risk (RR) of DKA, of glycemic (HbA1c, fasting plasma glucose, continuous glucose monitoring parameters, insulin dose, and insulin sensitivity indices) and non-glycemic (body mass index (BMI), systolic BP, renal function, albuminuria, and diabetic eye disorders) efficacy, and of other safety outcomes (including hypoglycemia, infections, major adverse cardiovascular events, and death). Methods and findings: We searched MEDLINE, Cochrane Library, EMBASE, ClinicalTrials.gov , Cochrane CENTRAL Register of Controlled Trials, and other electronic sources through August 30, 2020, for RCTs comparing SGLT2i with active comparators or placebo in adult patients with T1DM. Reviewers extracted data for relevant outcomes, performed random effects meta-analyses, subgroup analyses, and multivariable meta-regression. The strength of evidence was summarized with the GRADE approach. Among 9,914 records identified, 18 placebo-controlled RCTs (7,396 participants, 50% males, mean age 42 y (range 23 to 55 y), 5 different SGLT2i evaluated), were included. Main outcome measures were effect sizes and moderators of glycemic and non-glycemic efficacy and of safety outcomes. In a multivariable meta-regression model, baseline BMI (β = 0.439 [95% CI: 0.211, 0.666], p < 0.001) and estimated glucose disposal rate (eGDR) (β = −0.766 [−1.276, −0.256], p = 0.001) were associated with the RR of DKA (RR: 2.81; 95% CI:1.97, 4.01; p < 0.001, R 2 = 61%). A model including also treatment-related parameters (insulin dose change-to-baseline insulin sensitivity ratio and volume depletion) explained 86% of variance across studies in the risk of DKA (R 2 = 86%). The association of DKA with a BMI >27 kg/m 2 and with an eGDR <8.3 mg/kg/min was confirmed also in subgroup analyses. Among efficacy outcomes, the novel findings were a reduction in albuminuria (WMD: −9.91, 95% CI: −16.26, −3.55 mg/g, p = 0.002), and in RR of diabetic eye disorders (RR: 0.27[0.11, 0.67], p = 0.005) associated with SGLT2i. A SGLT2i dose-response gradient was consistently observed for main efficacy outcomes, but not for adverse events (AEs). Overall, predictors of DKA and of other AEs differed substantially from those of glycemic and non-glycemic efficacy. A limitation of our analysis was the relatively short (≤52 weeks) duration of included RCTs. The potential relevance for clinical practice needs also to be confirmed by real-world prospective studies. Conclusions: In T1DM, the risk of DKA and main therapeutic responses to SGLT2i are modified by baseline BMI and insulin resistance, by total insulin dose reduction-to-baseline insulin sensitivity ratio, and by volume depletion, which may enable the targeted use of these drugs in patients with the greatest benefit and the lowest risk of DKA.

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  • Cardiovascular and heart failure outcomes trials evaluating SGLT inhibition had low rates of ketoacidosis but excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis.

    “Although there were low rates of ketoacidosis in the cardiovascular and heart failure outcomes trials evaluating SGLT inhibition, these studies excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis (309,312).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2025 (2025) · cites this paper as [312]

    The Results section reports ketoacidosis risk in SGLT2-inhibitor trials involving people with type 1 diabetes, not rates in cardiovascular or heart-failure outcomes trials. Searches for those trials and for exclusions based on type 1 diabetes or recent ketoacidosis found no passage addressing the claim in our copy. (LLM, conf=0.72)

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  • Although there were low rates of ketoacidosis in the cardiovascular and heart failure outcomes trials evaluating SGLT inhibition, these studies excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis.

    “Although there were low rates of ketoacidosis in the cardiovascular and heart failure outcomes trials evaluating SGLT inhibition, these studies excluded individuals with type 1 diabetes and/or recent history of diabetic ketoacidosis (296,298).”

    From 10. Cardiovascular Disease and Risk Management: Standards of Care in Diabetes—2026 (2026) · cites this paper as [298]

    The Methods (Study selection; page unavailable) and Results (DKA; page unavailable) concern trials of SGLT2 inhibitors in people with type 1 diabetes, not the cardiovascular or heart-failure outcomes trials named in the claim. Searches for those trials’ ketoacidosis rates and exclusions, including recent DKA, found no passage addressing them in our copy. (LLM, conf=0.73)

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Authors
Musso, G., Sircana, A., Saba, F., Cassader, M., & Gambino, R.
Affiliations
  • Ospedale Humanitas Gradenigo (IT)
  • Azienda Ospedaliero Universitaria di Sassari (IT)
  • University of Turin (IT)
Corresponding author
Musso, Giovanni
ORCID
Venue
PLOS Medicine
Publisher
Public Library of Science (PLoS)
Published
2020-12-29
Volume
17
Issue
12
Pages
e1003461
ISSN
  • 1549-1277 (ISSN-L)
  • 1549-1676
DOI
10.1371/journal.pmed.1003461
PMC
PMC7771708
OpenAlex
W3116973135
Cited by
61
References
14
Citations by year
2026: 13 · 2025: 11 · 2024: 11 · 2023: 9 · 2022: 10 · 2021: 7
FWCI
1.04
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS Medicine (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
  • RePEc: Research Papers in Economics (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
SGLT2 inhibitors, type 1 diabetes, diabetic ketoacidosis, estimated glucose disposal rate, insulin dose, hypoglycemia, major adverse cardiovascular events, renal safety, albuminuria, drug safety, patient selection, continuous glucose monitoring, insulin sensitivity index, HbA1c, fasting blood glucose
MeSH terms
Sodium-Glucose Transporter 2 Inhibitors, Adult, Diabetes Mellitus, Type 1, Female, Humans, Male, Middle Aged, Risk Factors, Randomized Controlled Trials as Topic, Diabetic Ketoacidosis, Treatment Outcome, Risk Assessment, Young Adult

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