Beta-Hydroxybutyrate Levels and Risk of Diabetic Ketoacidosis in Adults with Type 1 Diabetes Treated with Sotagliflozin
Primary result · Median fasting BHB change (baseline median 0.13 mmol/L)Result — go to the resultIncrease in median fasting BHB 0.04 mmol/L 95% CI 0.03–0.05Authors' conclusion
Incremental increases in baseline BHB and ΔBHB were associated with a higher DKA risk independent of treatment. Adding sotagliflozin to insulin increased median BHB over 24 weeks in patients with T1D and was associated with increased DKA events.
Study context
- Population
- Adults with T1D receiving sotagliflozin as an insulin adjunct or placebo; inTandem3 population for beta-hydroxybutyrate (BHB) analyses, pooled inTandem1–3 for diabetic ketoacidosis (DKA)pooled inTandem1–3 · inTandem3 population 1,402
- Participants
- 2,453 adults
- Comparison
- Sotagliflozin 400 mg vs placebo as insulin adjunct
- Primary endpoint
- Change in BHB from baseline (ΔBHB)
- Follow-up
- 24 weeks
Methodological detailsplacebo-controlled, pooled analysis
- Placebo-controlled
- Pooled analysis
Primary result
As reported in the abstract
Median fasting BHB change (baseline median 0.13 mmol/L)
Increase in median fasting BHB
0.04 mmol/L
95% CI 0.03–0.05
P < 0.001
Sotagliflozinvs Placebo
increase in median fasting BHB 0.04 mmol/L (95% CI 0.03–0.05); P < 0.001
- Patients with no or minimal changes in BHB over time
- 67%
Further findings
Factors associated with on-treatment BHB >0.6 or >1.5 mmol/L
- Baseline BHB and sotagliflozin use were associated with on-treatment BHB >0.6 or >1.5 mmol/L
- inTandem3 population; N = 1402
Predictors of DKA episodes
- Increase in DKA risk per 0.1-mmol/L increase in baseline BHB, independent of treatment
- 18%
- Increase in DKA risk per 0.1-mmol/L increase from baseline, independent of treatment
- 8%
- Age, insulin pump use, sotagliflozin use, baseline BHB and ΔBHB significantly associated with DKA
- Pooled analysis (inTandem1-3; N = 2453)
Safety
- Sotagliflozin use significantly associated with DKA episodes
Original publication
Beta-Hydroxybutyrate Levels and Risk of Diabetic Ketoacidosis in Adults with Type 1 Diabetes Treated with Sotagliflozin. Diabetes Technol Ther. Published 13 May 2024. doi:10.
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