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MBX-2982

Phase 2

Diabetes | Small molecule | Metabolic |Gilead Sciences, Inc.|Last Updated: Apr 17, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

MBX-2982 · 1 trial · 1 indication

Phase 2 1
NCT01035879Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 DiabetesDiabetes
COMPLETED100 Analytics
PHASE2COMPLETED
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the effect of MBX-2982 on the absolute and percent change from baseline and placebo in mean weighted average of 14-point blood glucose levels associated with a standardized breakfast and lunch
4 weeks

Secondary Endpoints

Evaluate the effect of MBX-2982 on additional glycemic parameters.
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MBX-2982 25 mgEXPERIMENTAL -
MBX-2982 100 mgEXPERIMENTAL -
MBX-2982 300 mgEXPERIMENTAL -
Sitagliptin 100 mgACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MBX-2982DRUGtablets and capsule once daily
SitagliptinDRUGtablets and capsule once daily
placeboDRUGtablets and capsule once daily
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * History of type 2 diabetes of at least 3 months duration * Treatment-naïve (not on any anti-diabetic medication) or treated with a single anti-diabetic agent (excluding insulin, exenatide or other GLP-1 analogs, pioglitazone or rosiglitazone) * HbA1c 7.0-8.5% (inclusive) at sc...

Countries:United StatesGeorgiaIndia
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about MBX-2982

What is MBX-2982 used for?

MBX-2982 is an investigational small molecule being developed for the treatment of diabetes. It was studied as a monotherapy in patients with type 2 diabetes. The drug is in Phase 2 clinical development and is not approved by the FDA.

Who makes MBX-2982?

MBX-2982 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 2 clinical development for the treatment of diabetes.

What phase is MBX-2982 in?

MBX-2982 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is MBX-2982 in?

MBX-2982 has one completed clinical trial, NCT01035879, which evaluated the efficacy, safety, tolerability, and pharmacokinetics of the drug administered daily for 4 weeks as monotherapy in patients with type 2 diabetes. The trial enrolled 100 participants in the United States, Georgia, and India.

Is MBX-2982 FDA approved?

MBX-2982 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for the treatment of diabetes. The completed Phase 2 trial was a randomized, double-blind, placebo-controlled study, but the drug has not yet received regulatory approval.