Tolerability, safety and pharmacodynamics of oral, small‐molecule glucagon‐like peptide‐1 receptor agonist danuglipron for type 2 diabetes: A 12‐week, randomized, placebo‐controlled, Phase 2 study comparing different dose‐escalation schemes
Authors' conclusion
Danuglipron resulted in statistically significant reductions in HbA1c, FPG and body weight over 12 weeks, in the setting of higher discontinuation rates and incidence of gastrointestinal adverse events with higher target doses.
Study context
- Population
- Adults with T2D treated with metformin (mean HbA1c 8.19%) and adults with obesity without diabetes (mean BMI 37.3 kg/m²)T2D n = 123
- Comparison
- Danuglipron dose-escalation schemes vs placebo
- Primary endpoint
- Tolerability, safety and pharmacodynamics of different dose-escalation schemes
- Follow-up
- 12 weeks
Methodological detailsPhase 2a, double-blind, placebo-controlled, parallel-group
- Phase 2a
- Double-blind
- Placebo-controlled
- Parallel-group
Primary result
As reported in the abstract
Discontinuation from study medication
Danuglipron
27.3% to 72.7%
Placebo
16.7% to 18.8%
Further findings
| Outcome | Danuglipron | Placebo | P value |
|---|---|---|---|
| LS mean change from baseline in HbA1c (T2D) · Week 12Generally statistically significant | least squares mean −1.04% to −1.57% | least squares mean −0.32% | P < 0.05 |
| LS mean change from baseline in FPG (T2D) · Week 12Generally statistically significant | least squares mean −23.34 mg/dL to −53.94 | least squares mean −13.09 mg/dL | P < 0.05 |
| LS mean change from baseline in body weight (T2D) · Week 12Generally statistically significant | least squares mean −1.93 to −5.38 kg | least squares mean −0.42 kg | P < 0.05 |
Safety
| Outcome | Danuglipron | Placebo |
|---|---|---|
| Nausea (T2D) | 20.0%-47.6% | 12.5% |
| Vomiting (T2D) | 18.2%-40.9% | 12.5% |
Vomiting (T2D)
- GI adverse events generally related to target dose, not substantially affected by starting dose
Original publication
Tolerability, safety and pharmacodynamics of oral, small‐molecule glucagon‐like peptide‐1 receptor agonist danuglipron for type 2 diabetes: A 12‐week, randomized, placebo‐controlled, Phase 2 study comparing different dose‐escalation schemes. Diabetes Obes Metab. Published 13 June 2023. doi:10.
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