Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial
Primary result · Change from baseline in HbA1cResult — go to the resultLeast squares mean difference −1.16 % 90% CI −1.47% to −0.86%Authors' conclusion
In adults with T2D, danuglipron reduced HbA1c, FPG, and body weight at week 16 compared with placebo, with a tolerability profile consistent with the mechanism of action.
Study context
- Population
- Adults with T2D inadequately controlled by diet and exercise, with or without metformin; 97 sites in 8 countries or regions; mean (SD) age 58.6 (9.3) years, 51% male316 completed treatment
- Participants
- 411 adults
- Comparison
- Oral danuglipron vs placebo
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- Week 16
Methodological detailsphase 2b, double-blind, placebo-controlled, parallel-group, 6-group, multicentre, Conducted July 7, 2020, to July 7, 2021; 16-week double-blind treatment and 4-week follow-up
- Phase 2b
- Double-blind
- Placebo-controlled
- Parallel-group
- 6-group
- Multicentre
- Conducted July 7, 2020, to July 7, 2021; 16-week double-blind treatment and 4-week follow-up
Primary result
As reported in the abstract
Least squares mean difference
−1.16 %
90% CI −1.47% to −0.86%
Danuglipron 120 mgvs Placebo
least squares mean difference −1.16 % (90% CI −1.47% to −0.86%)
Further findings
| Outcome | Least squares mean difference (kg) (90% CI) | |
|---|---|---|
| Change from baseline in body weight · week 16Danuglipron 80 mgvs Placebo | −2.04 (−3.01 to −1.07 kg) | |
| Change from baseline in body weight · week 16Danuglipron 120 mgvs Placebo | −4.17 (−5.15 to −3.18 kg) | |
| −10−505Difference, kg (linear scale) |
Change from baseline in fasting plasma glucose (FPG) · week 16
- Largest FPG reduction, least squares mean difference vs placebo
- −33.24 mg/dL (90% CI −45.63 to −20.84 mg/dL)
- FPG statistically significantly reduced vs placebo with all danuglipron doses
Change from baseline in body weight · week 16
- Body weight statistically significantly reduced vs placebo only with 80 mg and 120 mg twice daily
Safety
Adverse events · 16 weeks plus 4-week follow-up
- Most commonly reported adverse events were nausea, diarrhea and vomiting
Original publication
Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. Published 1 May 2023. doi:10.
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