Vipdomet
Metabolic· 925 cited findings· 1 source document
What the regulatory reviews say
Vipdomet is a fixed-dose combination drug containing alogliptin and metformin, indicated for the treatment of type 2 diabetes mellitus. Alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, demonstrated an IC50 for DPP-4 inhibition of 6-18 nM. In studies, alogliptin decreased plasma glucose AUC(0-90min) by 75% of control and increased plasma insulin levels by 146% of control. When combined with metformin, alogliptin decreased plasma glucose AUC(0-120min) by 37-38%. The addition of pioglitazone to alogliptin and metformin further decreased plasma glucose AUC(0-120min) by 55%.
Key efficacy findings include a change from baseline in HbA1c ranging from -0.44% to -0.56% and a change from baseline in FPG ranging from -1.4 to -2.0 mmol/L. Safety data involved 6354 subjects receiving alogliptin, with 4201 subjects receiving alogliptin in combination with metformin. Metformin is contraindicated in male patients with serum creatinine levels >135 µmol/L and female patients with serum creatinine levels >110 µmol/L.
Vipdomet received Marketing Authorisation on 25 January 2013, following a CHMP positive opinion on 25 July 2013. Proposed commercial dosage strengths for alogliptin/metformin include 6.25mg+850mg, 6.25mg+1000mg, 12.5mg+850mg, and 12.5mg+1000mg.
Key figures — cited to the source page
| Alogliptin IC50 for DPP-4 inhibition | 6-18 | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.17 |
| Plasma glucose AUC(0-90min) decrease (alogliptin) | 75 | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.17 |
| Plasma glucose AUC(0-120min) decrease (alogliptin + metformin) | 37-38 | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.21 |
| HbA1c change from baseline | -0.54 | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.70 |
| FPG change from baseline | -2.0 | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.70 |
| Serum creatinine level for male patients (metformin contraindication) | >135 | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.54 |
| Marketing Authorisation date | 25 January 2013 | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.7 |
| Alogliptin/metformin combination dosage strengths proposed for commercial use | 6.25mg+850mg, 6.25mg+1000mg, 12.5mg+850mg and 12.5mg+1000mg | Takeda Pharmaceutical Company Limited — Vipdomet EMA EPAR pu, p.55 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.