Effect of dapagliflozin on 24-hour glycemic variables in Japanese patients with type 2 diabetes mellitus receiving basal insulin supported oral therapy (DBOT): a multicenter, randomized, open-label, parallel-group study
Authors' conclusion
This study showed that the mean daily blood glucose and other daily glucose profiles were amended after 48-72 hours of dapagliflozin add-on in Japanese patients with type 2 diabetes who received BOT. The diabetes-related biochemical variables such as HbA1c and urinary 8OHdG were also obtained during the 12 weeks of dapagliflozin add-on without major adverse events. A preferable 24-hour glucose profile in 'time in ranges' and an improvement in reactive oxygen species by dapagliflozin warrant us to evaluate these benefits in larger clinical studies.
Study context
- Population
- Japanese patients with T2D receiving basal insulin supported oral therapy (BOT)
- Participants
- 36 patients
- Comparison
- Dapagliflozin add-on vs no add-on
- Dapagliflozin add-onn = 18
- No add-onn = 18reference
- Primary endpoint
- Change in mean daily blood glucose level before and after add-on or no add-on of dapagliflozin
- Follow-up
- 48-72 hours
Methodological detailsmulticenter, two-arm, open-label, parallel-group
- Multicenter
- Two-arm
- Open-label
- Parallel-group
Primary result
As reported in the abstract
- Dapagliflozin add-on: mean glucose decreased, 183-156 mg/dL
- p=0.001
Secondary outcomes
Other CGM metrics in Dapagliflozin add-on · 48-72 hours
- Maximum glucose decreased, 300-253
- P < 0.01
- SD glucose decreased, 57-45
- P < 0.05
- Time in range increased
- P < 0.05
- Time above range decreased with dapagliflozin add-on but not with no add-on
8OHdG and hemoglobin A1c (HbA1c) · 12 weeks
- 8OHdG and HbA1c decreased after dapagliflozin add-on
Original publication
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