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 an investigational small molecule being developed for prediabetic state, healthy individuals, renal impairment, and Type 2 Diabetes Mellitus (T2DM). It is studied in conditions including Type 2 Diabetes and is currently in Phase 1 clinical development.
Vildagliptin is developed by Novartis AG, a pharmaceutical company traded on the stock exchange under the ticker symbol NVS. The drug is an investigational small molecule being studied for use in Type 2 Diabetes and related metabolic conditions.
Vildagliptin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for Type 2 Diabetes Mellitus and other conditions, with all 54 clinical trials completed to date.
Vildagliptin has completed 54 clinical trials, including NCT00414947, a bioequivalence study in healthy Chinese volunteers, and NCT00567047, a pharmacokinetic study in patients with renal impairment. These trials have enrolled over 25,000 participants across various conditions.
Vildagliptin is also known as LAF237. Clinical trials such as NCT00651105, which studied the effect of LAF237 on glucagon secretion in patients with Type 2 Diabetes and healthy subjects, refer to Vildagliptin by this alternative name.