ArticleBMC medicine2023
A multicentre, prospective, non-interventional study evaluating the safety of dapagliflozin in patients with type 2 diabetes in routine clinical practice in China (DONATE).
Article in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03156985 (Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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The trial behind it
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Multi-center, Single Arm, Observational Study to Evaluate the Safety of Dapagliflozin in Type 2 Diabetes Mellitus Patients in China
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.
- A systematic literature review on the burden of diabetic ketoacidosis in type 2 diabetes mellitus.Diabetes, obesity & metabolism · 2025Pooled it
- Real-world evidence of urinary tract infections and genital tract infections with sodium-glucose cotransporter-2 inhibitors (SGLT2i) alone or in combination with dipeptidyl peptidase-4 inhibitors (DPP4i) in individuals with type-2 diabetes mellitus in India.BMC endocrine disorders · 2026Observational
- Adverse Drug Reactions to SGLT2i Reported by Type 2 Diabetes New Users: An Active Surveillance Study.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Construction and validation of a clinical prediction model for diabetic ketoacidosis.Frontiers in medicine · 2025Article
- Influence of SGLT2i on Renal Progression in CKD Patients: A Multicenter Real-World Study in China.Kidney diseases (Basel, Switzerland)Article
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9 authors at 8 institutions in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundThere are few large-scale studies evaluating the safety of the sodium-glucose cotransporter-2 inhibitor, dapagliflozin, in Chinese patients with type 2 diabetes. DONATE, a multicentre, single-arm, prospective, non-interventional study, is the first real-world study evaluating the safety of dapagliflozin in Chinese patients with type 2 diabetes in routine clinical practice.
methodsBetween August 2017 and July 2020, patients with type 2 diabetes who had initiated dapagliflozin therapy and received ≥1 dose were prospectively recruited from 88 hospitals in China. Patients were subsequently followed up for 24 weeks; if patients discontinued dapagliflozin they were followed up for an additional 7 days after treatment discontinuation. The primary outcome was the proportion of patients with adverse events and serious adverse events, particularly key adverse events of special interest (AESI) including urinary tract infection, genital tract infection (typical symptoms with or without microbiological diagnosis) and hypoglycaemia (typical symptoms with or without blood glucose ≤3.9 mmol/L, or blood glucose ≤3.9 mmol/L without symptoms). Exploratory outcomes included the absolute change in metabolic parameters and the proportion of patients with other AESI including volume depletion, abnormal blood electrolytes, polyuria, renal impairment, diabetic ketoacidosis, hepatic impairment and haematuria.
resultsA total of 3000 patients were enrolled, of whom 2990 (99.7%) were included in the safety analysis set. Mean (SD) age was 52.6 (12.0) years, and 65.8% of patients were male. Mean (SD) duration of type 2 diabetes at enrolment was 8.4 (7.1) years. Mean (SD) treatment duration of dapagliflozin was 209.1 (157.6) days. Adverse events were reported in 35.4% (n = 1059) of patients during the 24-week follow-up period. Overall, 9.0% (n = 268) were related to treatment and 6.2% (n = 186) were serious. Urinary tract infection, genital tract infection and hypoglycaemia were reported in 2.3% (n = 70), 1.3% (n = 39) and 1.1% (n = 32) of patients, respectively. The proportion of patients with other AESI was also low: polyuria (0.7%; n = 21), volume depletion (0.3%; n = 9), renal impairment (0.3%; n = 8), hepatic impairment (0.2%; n = 7), haematuria (0.2%; n = 6) and diabetic ketoacidosis (0.1%; n = 2).
conclusionsThis study demonstrated that once-daily dapagliflozin was well tolerated in Chinese patients with type 2 diabetes and the overall safety profile of dapagliflozin in clinical practice in China was consistent with that reported in clinical trials.
trial registrationClinicalTrials.gov, NCT03156985. Registered on 16 May, 2017.
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