Oral insulin ( ORMD ‐0801) in type 2 diabetes mellitus: A dose‐finding 12‐week randomized placebo‐controlled study
Primary result · Placebo-adjusted HbA1c change from baselineResult — go to the resultPlacebo-adjusted HbA1c change −0.65%Authors' conclusion
Oral insulin (ORMD-0801) induced greater reductions in HbA1c when compared to placebo, and was safe and well tolerated in individuals with uncontrolled T2DM. The efficacy and safety findings support continued development of the 8-mg dose at bedtime, which is currently being evaluated in two Phase 3 trials.
Study context
- Population
- Adults with T2D on metformin or combination oral therapy with HbA1c ≥ 7.5% (58 mmol/mol); ≈60% male, age ≈56 years, HbA1c 9%-9.8%randomized
- Participants
- 373 adults
- Comparison
- Oral insulin at various doses vs placebo
Methodological detailsdose-finding, placebo-controlled
- Dose-finding
- Placebo-controlled
Primary result
Placebo-adjusted HbA1c change from baseline · Week 12
Placebo-adjusted HbA1c change
−0.65%
P = 0.046
As reported in the abstract
Further findings
| Outcome | Placebo-adjusted HbA1c change (%) | P value |
|---|---|---|
| Placebo-adjusted HbA1c change, excluding two sites with site interaction · Week 128 mg QD vs Placebo · ± 0.37%; −8.89 ± 4.01 mmol/mol; n = 15 | −0.81 | P = 0.028 |
| Placebo-adjusted HbA1c change, excluding two sites with site interaction · Week 128 mg BID vs Placebo · ± 0.37%; −8.95 ± 4.08 mmol/mol; n = 17 | −0.82 | P = 0.029 |
| Placebo-adjusted HbA1c change, excluding two sites with site interaction · Week 1232 mg QD vs Placebo · ± 0.26%; −5.89 ± 2.78 mmol/mol; n = 69 | −0.54 | P = 0.036 |
| Placebo-adjusted HbA1c change, excluding two sites with site interaction · Week 1232 mg BID vs Placebo · ± 0.26%; −5.80 ± 2.83 mmol/mol; n = 68 | −0.53 | P = 0.042 |
| Placebo-adjusted HbA1c change, excluding two sites with site interaction · Week 1216 mg QD vs Placebo · ± 0.37%; 2.76 ± 3.99 mmol/mol; n = 18; no effect | 0.25 | P = 0.48 |
| Placebo-adjusted HbA1c change, excluding two sites with site interaction · Week 1216 mg BID vs Placebo · ± 0.40%; −3.97 mmol/mol; n = 15; no effect | −0.36 | P = 0.36 |
| Placebo-adjusted HbA1c change, excluding two sites with site interaction · Week 1232 mg TID vs Placebo · ± 0.27%; −4.89 ± 2.90 mmol/mol; n = 69; no effect | −0.45 | P = 0.093 |
CGM and serum glucose
- Similar trends but not significant
Safety
- ORMD-0801 was safe, well tolerated and not associated with weight gain or hypoglycaemia
Original publication
Oral insulin ( ORMD ‐0801) in type 2 diabetes mellitus: A dose‐finding 12‐week randomized placebo‐controlled study. Diabetes Obes Metab. Published 21 November 2022. doi:10.
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