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ONO-5129

Phase 2

Type 2 Diabetes Mellitus | Small molecule | Metabolic |BrainsWay Ltd.|Last Updated: Jun 13, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment81

FDA Designations

No designations recorded

Clinical trial landscape

ONO-5129 · 1 trial · 1 indication

Phase 2 1
NCT00335712Pilot Study of ONO-5129 in Patients With Type 2 Diabetes MellitusType 2 Diabetes Mellitus
COMPLETED81 Analytics
PHASE2COMPLETED
Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Fasting Blood Glucose at week 8

Secondary Endpoints

Other glycemic control parameters (e.g., HbA1c, glycoalbumin)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ONO-5129DRUG -
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Eligibility Criteria

Age Range45 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Fasting Blood Glucose 126-250mg/dL 2. HbA1c 6.5-11% Exclusion Criteria: 1. Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization 2. History of myocardial infarction, coronary artery surgery 3. Other eligibility criteria as speci...

Countries:Japan
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Frequently asked questions about ONO-5129

What is ONO-5129 used for?

ONO-5129 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus. It is a metabolic therapeutic that has been studied in a Phase 2 clinical trial. The drug is not yet approved and remains in clinical development.

Who makes ONO-5129?

ONO-5129 is being developed by BrainsWay Ltd., a company traded on the NASDAQ under the ticker symbol BWAY. The drug is currently in Phase 2 clinical development for Type 2 Diabetes Mellitus.

What phase is ONO-5129 in?

ONO-5129 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a pilot study in patients with Type 2 Diabetes Mellitus. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ONO-5129 in?

ONO-5129 has been studied in one completed Phase 2 clinical trial, identified as NCT00335712. This was a pilot study involving 81 patients with Type 2 Diabetes Mellitus in Japan. The trial was randomized and double-blind, though it did not use a control group.

Is ONO-5129 the same as any other drug?

ONO-5129 is a distinct investigational drug candidate. No alternative names for ONO-5129 have been disclosed in the clinical trial information. It is being developed specifically for Type 2 Diabetes Mellitus and is not known to be identical to any other marketed medication.