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MBX-102

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Gilead Sciences, Inc.|Last Updated: May 1, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment396

FDA Designations

No designations recorded

Clinical trial landscape

MBX-102 · 1 trial · 1 indication

Phase 2 1
NCT00353587Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on InsulinType 2 Diabetes
COMPLETED396 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Metaglidasen in Type 2 Diabetes in Patients Suboptimally Controlled on Insulin
Type 2 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate effects of MBX-102 administered orally at doses of 200, 400 and 600 mg daily for 16 weeks, on glucose control, as measured by HbA1c
Evaluate safety of MBX-102 with particular emphasis on endpoints of weight gain and edema
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MBX-102 200 mgEXPERIMENTALMBX-102 200 mg once daily for 16 weeks
MBX-102 400 mgEXPERIMENTALMBX-102 400 mg once daily for 16 weeks
MBX-102 600 mgEXPERIMENTALMBX-102 600 mg once daily for 16 weeks
Sugar PillPLACEBO_COMPARATORPlacebo comparator once daily for 16 weeks
ActosACTIVE_COMPARATORActos 30 mg once daily for 16 weeks

Interventions

NameTypeDescription
MBX-102DRUGMBX-102 200 mg once daily for 16 weeks
PlaceboDRUGMBX-102 Placebo once daily for 16 weeks
ActosDRUGActos 30 mg once daily for 16 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * Type 2 diabetes (as described by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus24) treated with insulin alone (a stable dose of long and/or intermediate-acting insulin or pre-mixed insulin e.g., "70/30") ≥ 30 units/day for at least 3 months, but ...

Countries:United StatesArgentinaIndiaIsrael
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Frequently asked questions about MBX-102

What is MBX-102 used for?

MBX-102 is a small molecule being developed for the treatment of Type 2 Diabetes. It is currently in Phase 2 clinical development and is being studied in patients whose blood sugar is not adequately controlled with insulin therapy.

What does MBX-102 target?

The specific molecular target of MBX-102 has not been disclosed. It is a small molecule therapeutic being developed for Type 2 Diabetes, but its mechanism of action is not publicly detailed in the available information.

Who makes MBX-102?

MBX-102 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes.

What phase is MBX-102 in?

MBX-102 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it is not yet approved by regulatory authorities. The drug remains investigational and is being studied for its potential use in Type 2 Diabetes.

What clinical trials is MBX-102 in?

MBX-102 has one completed clinical trial, identified as NCT00353587. This was a Phase 2, randomized, double-blind, placebo-controlled study that enrolled 396 participants with Type 2 Diabetes who were suboptimally controlled on insulin. The trial was conducted in the United States, Argentina, India, and Israel.

Is MBX-102 the same as Metaglidasen?

Yes, MBX-102 is also known as Metaglidasen. The clinical trial NCT00353587, which evaluated the drug in Type 2 Diabetes, refers to it as Metaglidasen. Both names refer to the same investigational small molecule being developed by Gilead Sciences.