Safety, tolerability, pharmacodynamics and pharmacokinetics following once‐daily doses of BI 187004, an inhibitor of 11 beta‐hydroxysteroid dehydrogenase‐1, over 28 days in patients with type 2 diabetes mellitus and overweight or obesity
Authors' conclusion
BI 187004 was generally well tolerated in patients with T2DM. Despite complete 11β-HSD1 inhibition, no clinically relevant effects were observed with BI 187004.
Study context
- Population
- Adults with T2D and overweight or obesity (BMI 28–40 kg/m²)
- Participants
- 103 adults
- Comparison
- BI 187004 as monotherapy or with metformin vs placebo
- Arm 1n = 62
- Arm 2n = 41
Methodological detailsphase II, placebo-controlled, multiple rising doses
- Phase II
- Placebo-controlled
- Multiple rising doses
Primary result
As reported in the abstract
28 days
- Significant increase in weighted mean plasma glucose with 80 and 240 mg BI 187004, not FPG
- p < .05
Further findings
Pharmacokinetics
- BI 187004 rapidly absorbed; exposure increased approximately dose-dependently
Safety
| Outcome | Arm 1 | Arm 2 |
|---|---|---|
| Drug-related adverse events | 22.6% | 24.4% |
Drug-related adverse events
- Most frequent: headache, diarrhoea, flushing and dizziness
Heart rate
- Dose-dependent increase in heart rate with BI 187004
Original publication
Safety, tolerability, pharmacodynamics and pharmacokinetics following once‐daily doses of BI 187004, an inhibitor of 11 beta‐hydroxysteroid dehydrogenase‐1, over 28 days in patients with type 2 diabetes mellitus and overweight or obesity. Diabetes Obes Metab. Published 22 December 2022. doi:10.
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