Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled phase 3 trial
Authors' conclusion
Cetagliptin monotherapy was effective and well tolerated in Chinese patients with T2D who had inadequate glycaemic control on exercise and diet.
Study context
- Population
- Chinese patients with T2D and inadequate glycaemic control on exercise and dietrandomized 2:2:1
- Participants
- 504 patients
- Comparison
- Cetagliptin 50 mg or 100 mg once daily vs placebo
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, 24-week double-blind then 28-week open-label phase
- Double-blind
- Placebo-controlled
- 24-week double-blind then 28-week open-label phase
Primary result
As reported in the abstract
24 weeks
Placebo-subtracted HbA1c reduction
−0.72 %
Cetagliptin 50 mg
Placebo-subtracted HbA1c reduction
−0.72 %
Cetagliptin 100 mg
Cetagliptin 50 mg
−1.08
%
Cetagliptin 100 mg
−1.07
%
Placebo
−0.35
%
Further findings
HbA1c <7.0%
HbA1c <7.0%
- Significantly higher proportion with both doses vs placebo
HbA1c reduction by baseline HbA1c subgroup
- Greater HbA1c reduction with cetagliptin in patients with baseline HbA1c ≥8.5% than <8.5%
FPG and 2-hour postmeal plasma glucose
- Cetagliptin significantly lowered FPG and 2-hour postmeal plasma glucose vs placebo
Safety
- Incidence of adverse experiences similar between cetagliptin and placebo
- No drug-related hypoglycaemia reported
Original publication
Efficacy and safety of cetagliptin as monotherapy in patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled phase 3 trial. Diabetes Obes Metab. Published 3 September 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →