Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled on diet and exercise: A multicentre, randomized, double‐blind, placebo‐controlled, Phase 3 trial
Authors' conclusion
Janagliflozin 25 mg and 50 mg monotherapy once-daily effectively improved glycaemic control, reduced body weight and blood pressure, improved HDL cholesterol and insulin sensitivity, and was generally well tolerated.
Study context
- Population
- Drug-naive Chinese patients with T2DM inadequately controlled on diet and exercise, HbA1c ≥7.0% (53 mmol/mol) and ≤10.5% (91 mmol/mol)randomized 1:1:1
- Participants
- 432 patients
- Comparison
- Janagliflozin 25 mg or 50 mg once daily vs placebo
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- 24 weeks
Methodological detailsmulticentre, double-blind, placebo-controlled, Phase 3, 28-week extension period
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 3
- 28-week extension period
Primary result
As reported in the abstract
Week 24
Each group vs placeboPlacebo-adjusted least squares mean change, % (95% CI)P value
Janagliflozin 25 mg−8.7 mmol/mol (95% CI −10.7 mmol/mol to −6.8 mmol/mol)
−0.80(−0.98% to −0.62%)
P < 0.001Janagliflozin 50 mg−9.6 mmol/mol (95% CI −11.6 mmol/mol to −7.7 mmol/mol)
−0.88(−1.06% to −0.70%)
P < 0.001Further findings
HbA1c <7.0% (53 mmol/mol) achieved · Week 24
FPG, 2-hour postprandial glucose, body weight, systolic blood pressure, HDL-C, insulin sensitivity
- Both doses significantly decreased FPG, 2-hour postprandial glucose, body weight and systolic BP, and increased HDL-C and insulin sensitivity vs placebo (P < 0.05 for all)
- Improvement trends sustained during the 28-week extension period
Safety
Overall adverse events
Urinary tract and genital fungal infections; severe hypoglycaemia; ketoacidosis
- Incidence of urinary tract infections and genital fungal infections was low
- No severe hypoglycaemia or ketoacidosis occurred
Original publication
Efficacy and safety of janagliflozin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled on diet and exercise: A multicentre, randomized, double‐blind, placebo‐controlled, Phase 3 trial. Diabetes Obes Metab. Published 20 January 2023. doi:10.
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