Saxagliptin combined with additional oral antihyperglycaemic agents in drug‐naive diabetic patients with high glycosylated haemoglobin: A 24‐week, multicentre, randomized, open‐label, active parallel‐controlled group clinical trial in China ( SUCCESS )
Authors' conclusion
Initial treatment with a DPP-4 inhibitor combined with Metform, alpha-glycosidase inhibitor or sulphonylurea was safe and effective for patients with newly diagnosed T2DM and high HbA1c. DPP-4 inhibitor combined with Met showed the best efficacy for this population.
Study context
- Population
- Drug-naive Chinese patients with newly diagnosed T2D, 8.0% ≤ HbA1c ≤ 11.0%, aged 18–80 years, body mass index (BMI) 19–40 kg/m²583 completed
- Participants
- 648 patients
- Comparison
- Saxagliptin combined with metformin vs acarbose vs gliclazide modified release (MR)
- Saxagliptin (Saxa) + metformin (Met)n = 216
- Saxa + Acan = 216
- Saxa + gliclazide (Gli)n = 216
- Primary endpoint
- Absolute change in HbA1c from baseline
- Follow-up
- 24 weeks
Methodological detailsmulticentre, open-label, active parallel-controlled, 24-week, Conducted between 30 December 2014 and 1 November 2017
- Multicentre
- Open-label
- Active parallel-controlled
- 24-week
- Conducted between 30 December 2014 and 1 November 2017
Primary result
As reported in the abstract
Change in HbA1c from baseline
Saxa + Met
−2.9
mean · 95% CI −3.1–-2.8 · %
Saxa + Aca
−2.6
mean · 95% CI −2.8–-2.5 · %
Saxa + Gli
−2.8
mean · 95% CI −2.9–-2.6 · %
Saxa + Aca vs Saxa + Met: P = 0.010 · Saxa + Gli vs Saxa + Met: P = 0.18
- Overall difference across the three arms
- overall p = .04
Secondary outcomes
Patients achieving HbA1c <7.0% · 24 weeks
Patients achieving HbA1c ≤6.5% · 24 weeks
- Patients achieving HbA1c <7.0% — Overall difference across the three arms
- overall p = .05
- Patients achieving HbA1c ≤6.5% — Overall difference across the three arms
- overall p = 0.10
Safety
- Rates of minor or symptomatic hypoglycaemia were very low
Original publication
Saxagliptin combined with additional oral antihyperglycaemic agents in drug‐naive diabetic patients with high glycosylated haemoglobin: A 24‐week, multicentre, randomized, open‐label, active parallel‐controlled group clinical trial in China ( SUCCESS ). Diabetes Obes Metab. Published 14 October 2022. doi:10.
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