Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
vildagliptin · 71 trials · 12 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 | ACTIVE_COMPARATOR | sitagliptin (25mg qd) |
| 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 |
| 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Vildagliptin is used for Type 2 Diabetes Mellitus (T2DM), including pre-diabetes, renal impairment, and related diabetes mellitus type 2 conditions. It is a small molecule being developed by Novartis AG as an investigational therapy. The drug is currently in Phase 1 clinical development, though it has completed multiple Phase 2 trials.
Vildagliptin is a small molecule developed for Type 2 Diabetes Mellitus. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being studied for its effects on postprandial lipid parameters and glycemic control in patients with type 2 diabetes.
Vildagliptin is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. The drug is an investigational small molecule intended for the treatment of Type 2 Diabetes Mellitus and related conditions.
Vildagliptin is currently in Phase 1 clinical development. However, it has completed 54 clinical trials, including several Phase 2 studies. These completed trials have enrolled a total of 25,132 participants. The drug is not approved and remains investigational.
Vildagliptin has completed 54 clinical trials, including NCT00099957, NCT00238498, NCT00821977, and NCT00860288. These trials studied the drug's efficacy and safety in patients with Type 2 Diabetes, both as monotherapy and as add-on therapy to metformin. All trials are completed, with no active trials ongoing.
Vildagliptin is also known by the brand name Galvus, though this alternative name is not provided in the available data. The drug is being developed by Novartis AG for Type 2 Diabetes Mellitus and is currently in Phase 1 clinical development.