Incresync
MetabolicΒ· 658 cited findingsΒ· 1 source document
What the regulatory reviews say
Incresync is a drug indicated for the treatment of type 2 diabetes mellitus. Its efficacy has been evaluated through various metrics, including DPP-4 inhibition and PPARΞ³ activation. Key efficacy findings include a decrease in plasma glucose AUC(0-90min) by 75% of control and an increase in plasma insulin levels by 146% of control. In clinical trials, Incresync demonstrated a decrease in plasma glucose levels by 57% of control when compared to pioglitazone, 78% of control when compared to metformin, and 38% of control when compared to pioglitazone + metformin. Hemoglobin A1 reduction was 82% of control when compared to pioglitazone + metformin.
Safety findings include lethal single oral doses of alogliptin in rats at 1471 mg/kg and in dogs at 368 mg/kg. The NOAEL for alogliptin in rats after 6 months exposure was 400 mg/kg/day. Deaths attributed to Alogliptin 12.5 mg were reported at 0.2%. The drug underwent Phase III trials with durations of 52 weeks for the main phase and 4 weeks for the run-in phase, involving up to 2638 subjects.
Regulatory milestones include Marketing Authorisation in the US on 25 January 2013 and in Japan on 1 July 2011. The Marketing Authorisation Application was submitted on 30 May 2012, with a positive opinion from the CHMP for Marketing Authorisation on 25 July 2013.
Key figures β cited to the source page
| Plasma glucose AUC(0-90min) decrease | 75 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.20 |
| Plasma insulin levels increase | 146 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.20 |
| Plasma glucose levels decrease (pioglitazone) | 57 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.25 |
| Plasma glucose levels decrease (metformin) | 78 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.25 |
| Hemoglobin A1 reduction (pioglitazone + metformin) | 82 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.25 |
| Deaths (Alogliptin 12.5 mg) | 0.2 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.97 |
| Marketing Authorisation in US | 25 January 2013 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.8 |
| CHMP positive opinion for Marketing Authorisation | 25 July 2013 | Takeda Pharmaceutical Company Limited β Incresync EMA EPAR p, p.9 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials β values are not head-to-head comparisons). Educational reference only β not medical or investment advice.