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GEMIGLIPTIN LS15-0444 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Gemigliptin | EXPERIMENTAL | GEMIGLIPTIN LS15-0444 administered once a day for 24 weeks as add-on therapy to metformin |
| Vildagliptin | ACTIVE_COMPARATOR | Vildagliptin administered twice a day for 24 weeks as add-on therapy to metformin |
| Name | Type | Description |
|---|---|---|
| GEMIGLIPTIN LS15-0444 | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| vildagliptin | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| metformin | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria: * Patients with Type 2 diabetes mellitus. * Patients inadequately controlled with metformin at the maximal effective and tolerated dose of metformin for at least 12 weeks or who are on a stable dose of ≥1500 mg daily for a minimum of ≥4 weeks prior to study entry. * Signed infor...
GEMIGLIPTIN LS15-0444 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is intended for use as an add-on therapy to metformin in people whose blood sugar is inadequately controlled with metformin alone.
GEMIGLIPTIN LS15-0444 is being developed by Sanofi, a global biopharmaceutical company. Sanofi's stock is traded under the ticker symbol SNY.
GEMIGLIPTIN LS15-0444 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
GEMIGLIPTIN LS15-0444 has one completed Phase 3 trial, NCT02343926. This study compared the efficacy and safety of gemigliptin and vildagliptin as add-on therapy to metformin in people with Type 2 Diabetes inadequately controlled with metformin. The trial enrolled 443 participants in Russia.
Yes, GEMIGLIPTIN LS15-0444 is the same as gemigliptin. The drug is referred to by both names, with GEMIGLIPTIN LS15-0444 being the full designation used in clinical development.