Safety and efficacy of an oral insulin ( Capsulin ) in patients with early‐stage type 2 diabetes: A dose‐ranging phase 2b study
Authors' conclusion
Capsulin oral insulin administered twice per day at a dose of 150 iu per capsule is safe, with no confirmed treatment-linked hypoglycaemic events, and results in significant decreases from baseline in HbA1c, FPG and triglycerides.
Study context
- Population
- Adults with T2D on metformin; mean (SD) age 48.5 (6.7) years, BMI 25.7 (2.8) kg/m², HbA1c 8.10% (0.65%)completed per protocol
- Participants
- 100 adults
- Comparison
- Oral regular human insulin capsules at 75, 150 or 300 iu BD
- Primary endpoint
- Change from baseline in HbA1c
- Follow-up
- 12 weeks
Methodological detailsopen-label, dose-ranging, phase 2b
- Open-label
- Dose-ranging
- Phase 2b
Primary result
As reported in the abstract
Change from baseline in HbA1c (least square mean decrease)
| Group | Value | Median decrease | P |
|---|---|---|---|
| 75 iu BD | least square mean −0.11% | ||
| 150 iu BD | least square mean decrease 0.52% | 0.6% | P = .004 |
| 300 iu BD | least square mean −0.42% |
Value
75 iu BDleast square mean −0.11%
150 iu BDleast square mean decrease 0.52%
300 iu BDleast square mean −0.42%
Median decrease
75 iu BD— not stated in the abstract
150 iu BD0.6%
300 iu BD— not stated in the abstract
P
75 iu BD— not stated in the abstract
150 iu BDP = .004
300 iu BD— not stated in the abstract
Secondary outcomes
| Outcome | 75 iu BD | 150 iu BD | 300 iu BD |
|---|---|---|---|
| Change in FPG · 12 weeksMean, mg/dl | −14.8 | −18.8 | −2.7 |
| P | — not stated in the abstract | P = .017 | — not stated in the abstract |
| TG | decrease 20% | ||
| Absolute decrease | — not stated in the abstract | −40 mg/dl | — not stated in the abstract |
— not stated in the abstract
- HbA1c change in subset with baseline HbA1c 9% to 9.5%, 150 iu BD
- 1.575% · average decrease
Body weight and systolic blood pressure
- No significant increases in body weight
- Significant decreases in systolic blood pressure in all groups
Safety
Adverse events and hypoglycaemia · 12 weeks
- Serious treatment-related adverse events
- 0
- Hypoglycaemia
- 0
Original publication
Safety and efficacy of an oral insulin ( Capsulin ) in patients with early‐stage type 2 diabetes: A dose‐ranging phase 2b study. Diabetes Obes Metab. Published 9 December 2022. doi:10.
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