A co‐formulation of pramlintide and insulin A21G ( ADO09 ) improves postprandial glucose and short‐term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes
Authors' conclusion
In comparison with aspart, ADO09 was well tolerated and effective in T1D across a wide range of dosage, significantly improving the average blood glucose level and body weight during 24 days of ambulatory treatment. Meal test profiles confirmed improvement of glycaemic patterns and other responses with ADO09.
Study context
- Population
- Adults with T1D using ≤40 U bolus insulin per day (LD, n = 28) or 40–75 U (HD, n = 16)LD n = 28
- Comparison
- Prandial ADO09 vs insulin aspart over 24 days
- Primary endpoint
- Glucose increments from 0 to 4 h after mixed-meal-tolerance test
- Follow-up
- End of treatment (24 days)
Methodological detailsdouble-blinded, two-period cross-over
- Double-blinded
- Two-period cross-over
Primary result
As reported in the abstract
Glucose increment 0–4 h after mixed-meal-tolerance test
Lower with ADO09 vs aspart, LD (not statistically significant)
39%
Lower with ADO09 vs aspart, HD
69%
Further findings
| Outcome | Estimate | P value |
|---|---|---|
| Mean CGM glucose during ambulatory treatment, ADO09 vs aspartADO09 vs Aspart · ± 7.9; lower with ADO09 | difference (LD) −8.2 mg/dl | P = 0.0001 |
| Mean CGM glucose during ambulatory treatment, ADO09 vs aspartADO09 vs Aspart · ± 10; lower with ADO09 | difference (HD) −7.0 mg/ml | P = 0.0127 |
| TIR (70-180 mg/dl), ADO09 vs aspartADO09 vs Aspart · improved with ADO09 | difference (LD) +4% | P = 0.0134 |
| TIR (70-180 mg/dl), ADO09 vs aspartADO09 vs Aspart · improved with ADO09 | difference (HD) +4% | P = 0.0432 |
Body weight with ADO09
kg
- Significant decline with ADO09, LD
- −0.8
- Significant decline with ADO09, HD
- −1.6
Safety
Events
| Outcome | ADO09 | Aspart |
|---|---|---|
| Hypoglycaemic events (LD) | 142 | 115 |
| Hypoglycaemic events (HD) | 96 | 79 |
- Hypoglycaemic events (LD): slightly more frequent with ADO09
- Hypoglycaemic events (HD): slightly more frequent with ADO09
Gastrointestinal and other events
- GI events more frequent with ADO09 but generally transient; no other safety signals
Original publication
A co‐formulation of pramlintide and insulin A21G ( ADO09 ) improves postprandial glucose and short‐term control of mean glucose, time in range, and body weight versus insulin aspart in adults with type 1 diabetes. Diabetes Obes Metab. Published 31 January 2023. doi:10.
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