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Also known as Zemiglo
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 patients whose blood sugar is not adequately controlled, including as add-on therapy to metformin. It has been studied in a Phase 3 trial in adults with Type 2 Diabetes.
GEMIGLIPTIN LS15-0444 targets DPP4, also known as dipeptidyl peptidase-4. It acts as a DPP4 inhibitor. By inhibiting this enzyme, the drug is designed to affect incretin hormones involved in glucose regulation, which is the mechanism explored for lowering blood sugar in Type 2 Diabetes Mellitus.
GEMIGLIPTIN LS15-0444 is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this DPP4 inhibitor in Type 2 Diabetes Mellitus.
GEMIGLIPTIN LS15-0444 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 3 trial for this asset has been completed, and no active trials are currently listed for it.
GEMIGLIPTIN LS15-0444 has been studied in one Phase 3 clinical trial, NCT02343926. This completed trial 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. It enrolled 443 participants in Russia.
Yes, GEMIGLIPTIN LS15-0444 is also known as gemigliptin. The identifier LS15-0444 refers to the same DPP4 inhibitor compound being developed by Sanofi for Type 2 Diabetes Mellitus.