A randomized, double‐blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of cetagliptin added to ongoing metformin therapy in patients with uncontrolled type 2 diabetes with metformin monotherapy
Authors' conclusion
The addition of cetagliptin once daily to metformin was more efficacious and well tolerated than metformin monotherapy in Chinese patients with type 2 diabetes who had inadequate glycaemic control with metformin monotherapy.
Study context
- Population
- Chinese patients with T2D with inadequate glycaemic control on metformin monotherapyrandomized 2:2:1
- Participants
- 446 patients
- Comparison
- Cetagliptin 100 mg or 50 mg once daily vs placebo, added to metformin
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- 24 weeks
Methodological detailsdouble-blind, placebo-controlled, randomized 2:2:1, 28-week open-label extension with cetagliptin 100 mg
- Double-blind
- Placebo-controlled
- Randomized 2:2:1
- 28-week open-label extension with cetagliptin 100 mg
Primary result
As reported in the abstract
Cetagliptin 100 mg
−1.17
± 0.794 · %
Cetagliptin 50 mg
−1.23
± 0.896 · %
Further findings
HbA1c <7.0% · 24 weeks
Haemoglobin A1c (HbA1c) <7.0% · 24 weeks
- Significantly greater proportion with both cetagliptin doses vs metformin monotherapy
HbA1c reduction by baseline HbA1c
- Greater HbA1c reductions with higher baseline HbA1c (≥8.5%)
HOMA β-function and systolic blood pressure
- Both combinations improved HOMA β-function index and decreased systolic blood pressure
Safety
- No increased risk of adverse effects with combination therapy; both generally well tolerated
Original publication
A randomized, double‐blind, placebo controlled, phase 3 trial to evaluate the efficacy and safety of cetagliptin added to ongoing metformin therapy in patients with uncontrolled type 2 diabetes with metformin monotherapy. Diabetes Obes Metab. Published 19 September 2023. doi:10.
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