Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial
Authors' conclusion
Cofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D.
Study context
- Population
- Drug-naïve patients with inadequately controlled T2D, China; median age 54.0 yearsrandomized 1:1:1
- Participants
- 475 patients
- Comparison
- Cofrogliptin 10 mg or 25 mg once every 2 weeks vs placebo
- Cofrogliptin 10 mgn = 158
- Cofrogliptin 25 mgn = 158
- Placebon = 159reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsmulticentre, double-blind, placebo-controlled, phase 3, 28-week open-label extension
- Multicentre
- Double-blind
- Placebo-controlled
- Phase 3
- 28-week open-label extension
Primary result
As reported in the abstract
Each group vs placeboLS mean difference, % (95% CI)P value
Cofrogliptin 10 mg
−0.63(−0.81 to −0.46)
P < 0.0001Cofrogliptin 25 mg
−0.59(−0.77 to −0.42)
P < 0.0001Further findings
Least-squares (LS) mean, %
| Outcome | Cofrogliptin 10 mg | Cofrogliptin 25 mg | Placebo |
|---|---|---|---|
| LS mean change in HbA1c from baseline after additional 28 weeks of open-label cofrogliptin 25 mg · end of study | −0.86 (SE 0.07) | −0.74 (SE 0.07) | −0.89 (SE 0.07) |
- LS mean change in HbA1c from baseline after additional 28 weeks of open-label cofrogliptin 25 mg: open-label extension; 401 entered
Safety
Adverse events · entire study
- Common AEs: hyperuricaemia, hyperlipidaemia, hypertriglyceridaemia, increased lipase, upper respiratory tract infection, urinary tract infection
- Hypoglycaemic events did not significantly differ between groups
Original publication
Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double‐blind, placebo‐controlled, phase 3 trial. Diabetes Obes Metab. Published 21 October 2024. doi:10.
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