Prusogliptin ( DBPR108 ) monotherapy in treatment‐naïve patients with type 2 diabetes: A randomized, double‐blind, active and placebo‐controlled, phase 3 study
Authors' conclusion
DBPR108 showed superiority to placebo and non-inferiority to sitagliptin in terms of glycaemic control over the initial 24 weeks in treatment-naïve patients with type 2 diabetes. Furthermore, its efficacy was sustained for up to 52 weeks.
Study context
- Population
- Adults with T2D not using glucose-lowering agents regularly for 8 weeks before screening; mean age 54.3 ± 10.5 years, 58% men, median T2D duration 0.38 (0.02, 2.65) years
- Participants
- 766 adults
- Comparison
- DBPR108 100 mg vs sitagliptin 100 mg vs placebo once daily
- DBPR108n = 462
- Sitagliptinn = 152
- Placebon = 152reference
- Primary endpoint
- Mean change in HbA1c from baseline
- Follow-up
- Week 24
Methodological detailsmulticentre, double-blind, active and placebo-controlled, phase 3, 28-week open-label extension
- Multicentre
- Double-blind
- Active and placebo-controlled
- Phase 3
- 28-week open-label extension
Primary result
As reported in the abstract
Change in HbA1c from baseline
DBPR108
−0.63
least square mean · SE 0.04% · %
Sitagliptin
−0.60
least square mean · SE 0.07% · %
Placebo
−0.02
least square mean · SE 0.07% · %
Mean treatment difference, % (95% CI)
DBPR108vs Placebosuperior to placebo
−0.61(−0.77% to −0.44%)
DBPR108vs Sitagliptinnon-inferior to sitagliptin
−0.03(−0.19% to 0.13%)
Further findings
HbA1c at baseline
Mean, %
| Outcome | DBPR108 | Sitagliptin | Placebo |
|---|---|---|---|
| Change in HbA1c from baseline · week 52 | −0.50 (SD 0.97%) | −0.46 (SD 0.96%) | −0.41 (SD 0.95%) |
- Change in HbA1c from baseline: all patients received DBPR108 100 mg in weeks 24–52 open-label extension
Fasting and postprandial plasma glucose; body weight
- DBPR108 significantly reduced fasting and postprandial plasma glucose and had little effect on body weight
Safety
- Incidence of adverse events comparable across all three groups
Original publication
Prusogliptin ( DBPR108 ) monotherapy in treatment‐naïve patients with type 2 diabetes: A randomized, double‐blind, active and placebo‐controlled, phase 3 study. Diabetes Obes Metab. Published 15 January 2024. doi:10.
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