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TAK-559

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Takeda Pharmaceutical Company Limited|Last Updated: Nov 12, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment302

FDA Designations

No designations recorded

Clinical trial landscape

TAK-559 · 1 trial · 1 indication

Phase 3 1
NCT00763022Efficacy of TAK-559 in Treating Subjects With Type 2 Diabetes MellitusDiabetes Mellitus
COMPLETED302 Analytics
PHASE3COMPLETED
Efficacy of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Baseline in Glycosylated hemoglobin.
Weeks: 4, 8, 12, 16, 20 and Final Visit.

Secondary Endpoints

Change in Baseline in Glycosylated hemoglobin.
Weeks: 4, 8, 12, 16, 20 and Final Visit.
Change in Baseline in Fasting Plasma Glucose.
Weeks: 2, 4, 8, 12, 16, 20 and Final Visit.
Change in Baseline in Serum insulin.
Weeks: 4, 12, 16, 20 and Final Visit.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAK-559 16 mg QDEXPERIMENTAL -
TAK-559 32mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
TAK-559DRUGTAK-559 16 mg, tablets, orally, once daily for up to 26 weeks.
PlaceboDRUGTAK-559 placebo-matching tablets, orally, once daily for up to 26 weeks.
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Eligibility Criteria

Age Range25 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Is diagnosed with type 2 diabetes mellitus using American Diabetes Association diagnostic criteria, and on a stable dose of an oral anti-diabetic monotherapy prior to Screening A. * Had a glycosylated hemoglobin level greater than or equal to 8.0% and less than or equal to 10....

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Frequently asked questions about TAK-559

What is TAK-559 used for?

TAK-559 is an investigational small molecule being developed for the treatment of Diabetes Mellitus, specifically type 2 diabetes. It is intended to help manage blood sugar levels in patients with this condition. The drug is currently in Phase 3 clinical development, meaning it is still being studied and has not yet been approved for commercial use.

Who makes TAK-559?

TAK-559 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and efficacy of TAK-559 in patients with type 2 diabetes.

What phase is TAK-559 in?

TAK-559 is in Phase 3 clinical development. This is the final stage of testing before a potential regulatory submission. The drug is being studied in a randomized, double-blind, placebo-controlled trial to assess its efficacy in treating subjects with type 2 diabetes mellitus. It is not yet approved by regulatory authorities.

What clinical trials is TAK-559 in?

TAK-559 has one completed Phase 3 clinical trial registered under NCT00763022, titled "Efficacy of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus." This trial enrolled 302 participants aged 25 years and older, with no healthy volunteers included. The study was randomized, double-blind, and placebo-controlled.

Is TAK-559 FDA approved?

TAK-559 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of type 2 diabetes mellitus. The completed Phase 3 trial (NCT00763022) evaluated its efficacy, but the drug has not yet received regulatory approval and remains under investigation.