Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LMF237 50 · 1 trial · 1 indication
HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.
| Arm | Type | Description |
|---|---|---|
| LMF237 50/250 mg | EXPERIMENTAL | Patients took LMF237 50/250 mg twice daily for 14 weeks |
| LMF237 50/500 mg | EXPERIMENTAL | Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks |
| Placebo | PLACEBO_COMPARATOR | Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks |
| Name | Type | Description |
|---|---|---|
| LMF237 50/250 mg | DRUG | Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily |
| LMF237 50/500 mg | DRUG | Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily |
| Placebo | DRUG | Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily |
Inclusion Criteria: * Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy * HbA1c in the range of 7.0-10.0% * Body mass index in the range of 20-35 kg/m\^2 Exclusion Criteria: * Type 1 diabetes, monogenic diabetes, diabetes resulting from pancr...
LMF237 50 is an investigational small molecule developed for the treatment of type 2 diabetes mellitus. It was studied in patients whose blood glucose was inadequately controlled with vildagliptin monotherapy. The drug is in Phase 3 development and has not been approved for commercial use.
LMF237 50 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis sponsored the Phase 3 clinical trial evaluating the drug in patients with type 2 diabetes mellitus in Japan.
LMF237 50 is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA or any regulatory authority based on the available information.
LMF237 50 was evaluated in a single Phase 3 trial, NCT01811485, titled Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy. The trial enrolled 171 patients in Japan, was randomized, double-blind, and placebo-controlled, and has been completed.
The Phase 3 trial NCT01811485 was a randomized, double-blind, placebo-controlled study of LMF237 50 in patients with type 2 diabetes mellitus inadequately controlled with vildagliptin monotherapy. It enrolled 171 patients aged 20 years and older in Japan and has been completed.