Efficacy and safety of janagliflozin as add‐on therapy to metformin in Chinese patients with type 2 diabetes inadequately controlled with metformin alone: A multicentre, randomized, double‐blind, placebo‐controlled, phase 3 trial
Authors' conclusion
Janagliflozin 25 or 50 mg once-daily added to metformin therapy significantly improved glycaemic control, reduced body weight and systolic blood pressure, improved high-density lipoprotein cholesterol and insulin sensitivity, and was generally well-tolerated by Chinese T2D patients who had poor glycaemic control with metformin monotherapy.
Study context
- Population
- Chinese patients with T2D inadequately controlled with metformin monotherapy, HbA1c ≥7.0% and ≤10.5%randomized 1:1:1
- Participants
- 421 patients
- Comparison
- Janagliflozin 25 or 50 mg once daily vs placebo, added to metformin
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- Week 24
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
Placebo-adjusted least squares mean change
−0.58 %
P < 0.0001
Janagliflozin 25 mg
Placebo-adjusted least squares mean change
−0.58 %
P < 0.0001
Janagliflozin 50 mg
Further findings
HbA1c <7.0% · week 24
FPG, 2-hour postprandial glucose, body weight, systolic BP, HDL-C, insulin sensitivity · week 24
- Both doses significantly reduced FPG, 2-hour postprandial glucose, body weight and systolic BP, and improved HDL-C and insulin sensitivity vs placebo
- P < 0.05 for all
- Improvement trends retained during the 28-week extension
Safety
Severe hypoglycaemia · 52 weeks
- No severe hypoglycaemia occurred throughout the whole 52-week treatment
Tolerability
- Janagliflozin 25 or 50 mg generally well tolerated
Original publication
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