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LMF237 50

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Novartis AG|Last Updated: Feb 23, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment171

FDA Designations

No designations recorded

Clinical trial landscape

LMF237 50 · 1 trial · 1 indication

Phase 3 1
NCT01811485Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin MonotherapyDiabetes Mellitus, Type 2
COMPLETED171 Analytics
PHASE3COMPLETED
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups
Baseline to 14 weeks

HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.

Secondary Endpoints

Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups
Baseline to 14 weeks
Percentage of Patients Meeting Responder Rates in HbA1c
Baseline, 14 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks
Baseline to 14 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LMF237 50/250 mgEXPERIMENTALPatients took LMF237 50/250 mg twice daily for 14 weeks
LMF237 50/500 mgEXPERIMENTALPatients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
PlaceboPLACEBO_COMPARATORPatients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks

Interventions

NameTypeDescription
LMF237 50/250 mgDRUGCorresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily
LMF237 50/500 mgDRUGCorresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily
PlaceboDRUGMatching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily
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Eligibility Criteria

Age Range20 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites30

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...

Countries:Japan
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Frequently asked questions about LMF237 50

What is LMF237 50 used for?

LMF237 50 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus (T2DM). It is intended for patients whose diabetes is inadequately controlled with vildagliptin monotherapy. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes LMF237 50?

LMF237 50 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 3 clinical trials for Type 2 Diabetes Mellitus, though it remains investigational and has not been approved for commercial use.

What phase is LMF237 50 in?

LMF237 50 is in Phase 3 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not received regulatory approval. The Phase 3 trial has been completed, but the drug is still considered investigational until it is approved by health authorities.

What clinical trials is LMF237 50 in?

LMF237 50 has one completed Phase 3 clinical trial, identified as NCT01811485. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of LMF237 in 171 patients with Type 2 Diabetes Mellitus inadequately controlled with vildagliptin monotherapy. The trial was conducted in Japan and enrolled adults aged 20 years and older.

Is LMF237 50 the same as vildagliptin?

No, LMF237 50 is not the same as vildagliptin. Vildagliptin is an existing diabetes medication used as monotherapy, while LMF237 50 is an investigational drug being studied as an add-on treatment for patients whose diabetes is not adequately controlled with vildagliptin alone. LMF237 50 is in Phase 3 clinical development.