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Also known as Vildagliptin (LAF237), Galvus, LAF237, LAF237A
vildagliptin · 72 trials · 13 indications
HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
| Arm | Type | Description |
|---|---|---|
| SU+metformin + Basal Insulin | ACTIVE_COMPARATOR | Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
| Metformin/vildagliptin + Basal Insulin | EXPERIMENTAL | Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG |
| Vildagliptin | EXPERIMENTAL | Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. |
| Placebo | PLACEBO_COMPARATOR | Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. |
| Glimepiride | ACTIVE_COMPARATOR | - |
| Vildagliptin (metformin + glimepiride) | EXPERIMENTAL | - |
| Placebo (metformin + glimepiride) | PLACEBO_COMPARATOR | - |
| Open Met add-on vildagliptin | OTHER | - |
| Open TZD add-on vildagliptin | OTHER | - |
| Open α-GI add-on vildagliptin | OTHER | - |
| Glinides add-on vildagliptin | OTHER | - |
| Vildagliptin Dose 1 | EXPERIMENTAL | - |
| Vildagliptin Dose 2 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | 50mg qd vildagliptin |
| 2 | PLACEBO_COMPARATOR | Placebo |
| vildagliptin + metformin | EXPERIMENTAL | - |
| metformin | ACTIVE_COMPARATOR | - |
| Sitagliptin | ACTIVE_COMPARATOR | - |
| TZD | ACTIVE_COMPARATOR | TZD + metformin |
| Vildagliptin + Metformin Dose 1 | EXPERIMENTAL | - |
| Vildagliptin + Metformin Dose 2 | EXPERIMENTAL | - |
| Gliclazide | ACTIVE_COMPARATOR | - |
| vildagliptin 50 mg qd + pioglitazone 45 mg qd | EXPERIMENTAL | vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks |
| vildagliptin 50 mg bd+ pioglitazone 45 mg qd | EXPERIMENTAL | vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks |
| Vildagliptin 50 mg bid + pioglitazone 45 mg qd | EXPERIMENTAL | Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks |
| Vildagliptin placebo + pioglitazone 45 mg qd | PLACEBO_COMPARATOR | Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks |
| LAF237 50 mg qd + glimepiride 4 mg qd | EXPERIMENTAL | LAF237 50 mg qd + glimepiride 4 mg qd |
| LAF237 50 mg bid + glimepiride 4 mg qd | EXPERIMENTAL | LAF237 50 mg bid + glimepiride 4 mg qd |
| LAF237 placebo + glimepiride 4 mg qd | PLACEBO_COMPARATOR | LAF237 placebo + glimepiride 4 mg qd |
| neuropathy | OTHER | patients with autonomic neuropathy |
| control | OTHER | patients without autonomic neuropathy (ewing score \<= 0.5) |
| Vildagliptin 25 mg qd in Renal Impaired (RI) patients | EXPERIMENTAL | - |
| Vildagliptin 50 mg qd in RI Patients | EXPERIMENTAL | - |
| Vildagliptin 25 mg qd in matched Healthy Volunteer (HV) | EXPERIMENTAL | - |
| Vildagliptin 50 mg qd in matched HV | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Vildagliptin | DRUG | 50 mg b.i.d |
| Metformin | DRUG | metformin is to be kept unchanged |
| sulfonylurea (SU) | DRUG | - |
| Basal Insulin | DRUG | - |
| Placebo | DRUG | Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks |
| Glimepiride | DRUG | - |
| Vildagliptin 50 mg bid | DRUG | - |
| Vildagliptin 50 mg qd | DRUG | - |
| sitagliptin | DRUG | 25mg qd |
| vildagliptin + metformin | DRUG | - |
| thiazolidinedione (TZD) | DRUG | TZD add-on to metformin |
| Vildagliptin 100 mg qd | DRUG | - |
| Metformin 1500 mg daily | DRUG | - |
| Vildagliptin matching placebo | DRUG | - |
| Glimepiride matching placebo | DRUG | - |
| Gliclazide | DRUG | - |
| pioglitazone | DRUG | pioglitazone 45 mg qd |
| Vildagliptin Placebo | DRUG | - |
| LAF237 placebo | DRUG | - |
| Metformin Comparator | DRUG | - |
| Vildagliptin (LAF237) | DRUG | - |
Inclusion Criteria: * T2DM patients inadequately controlled with metformin+ SU combination therapy at max tolerated doses and in whom the decision to start basal insulin has been taken * with stable metformin+ SU combination therapy for at least 12 weeks prior to randomization * with a glycemic tar...
Vildagliptin is used to treat type 2 diabetes and has also been studied in prediabetes, renal impairment, and healthy volunteers. It is a small molecule DPP4 inhibitor developed by Novartis AG (NVS). The clinical program includes 62 completed trials with a total enrollment of 27,375 participants across these metabolic indications.
Vildagliptin targets DPP4, also known as dipeptidyl peptidase-4. It is a DPP4 inhibitor, a small molecule that acts on this enzyme. By inhibiting DPP4, vildagliptin belongs to the incretin-based class of glucose-lowering agents used in type 2 diabetes. The target is recorded under ChEMBL identifier CHEMBL142703.
Vildagliptin is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor behind the clinical program, which includes 62 completed trials enrolling a total of 27,375 participants. The drug is a small molecule DPP4 inhibitor studied mainly in type 2 diabetes and related metabolic conditions.
Vildagliptin is in Phase 2 development according to its current program status. Its clinical record includes 62 completed trials and no active trials, with a total enrollment of 27,375 participants. The studies span Phase 2 and Phase 3 and cover type 2 diabetes, prediabetes, renal impairment, and healthy volunteer populations.
Vildagliptin has completed 62 trials, including NCT01871558, a Phase 3 study of vildagliptin plus metformin in type 2 diabetes patients starting basal insulin in France. NCT01582230 tested vildagliptin 50 mg twice daily added to insulin with or without metformin across China, the Philippines, Singapore, and Thailand. NCT01497522 and NCT01452113 are additional completed studies.