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TAK-875

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Takeda Pharmaceutical Company Limited|Last Updated: Apr 13, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials3
Total Enrollment1,747

FDA Designations

No designations recorded

Clinical trial landscape

TAK-875 · 7 trials · 3 indications

Phase 3 4Phase 2 2Phase 1 1
NCT01585792Double Blind Comparative Study of TAK-875Diabetic Patients
COMPLETED80 Analytics
NCT01433419Open-label Study of TAK-875Diabetes Mellitus
COMPLETED333 Analytics
NCT01433406Long-term Study of TAK-875Diabetes Mellitus
COMPLETED1,222 Analytics
NCT01433393Double-blind Comparative Study of TAK-875Diabetes Mellitus
COMPLETED192 Analytics
PHASE3COMPLETED
Double Blind Comparative Study of TAK-875
Diabetic PatientsUnlock trial analytics
PHASE3COMPLETED
Open-label Study of TAK-875
Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
Long-term Study of TAK-875
Diabetes MellitusUnlock trial analytics
PHASE3COMPLETED
Double-blind Comparative Study of TAK-875
Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Blood glucose
4 weeks
Adverse events
HbA1c
Change from Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline and Week 12.

The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 relative to baseline.

Change from Baseline in Glycosylated Hemoglobin at Week 12.
Baseline and Week 12
TAK-875 maximum observed plasma concentration (Cmax)
Day 14
TAK-875 time at which Cmax occurred (Tmax)
Day 14
TAK-875 area under the plasma concentration-time curve from time 0 to time tau, where tau is the length of a dosing interval AUC(0-tau)
Day 14
TAK-875 renal clearance (CLr)
Day 14
TAK-875 metabolite (M-I) Cmax
Day 14
TAK-875 M-I Tmax
Day 14
TAK-875 M-I AUC(0-tau)
Day 14
TAK-875 M-I renal clearance CLr
Day 14

Secondary Endpoints

Change from Baseline in Fasting Plasma Glucose
Baseline and Week 12.
Change from Baseline in Fasting Plasma Glucose at Week 12.
Baseline and Week 12
Change from Baseline in Body Weight at Week 12.
Baseline and Week 12
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Study Design & Arms

PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAK-875 25 mgEXPERIMENTAL -
TAK-875 50 mgEXPERIMENTAL -
GlimepirideACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Placebo QDPLACEBO_COMPARATOR -
TAK-875 25 mg QDEXPERIMENTAL -
TAK-875 50 mg QDEXPERIMENTAL -
Sitagliptin 100 mg QDEXPERIMENTAL -
TAK-875 25 mg QD + Sitagliptin 100 mg QDEXPERIMENTAL -
TAK-875 50 mg QD + Sitagliptin 100 mg QDEXPERIMENTAL -
TAK-875 6.25 mg QDEXPERIMENTAL -
TAK-875 100 mg QDEXPERIMENTAL -
TAK-875 200 mg QDEXPERIMENTAL -
Glimepiride 2 mg or 4mg QDACTIVE_COMPARATOR -
1EXPERIMENTAL -

Interventions

NameTypeDescription
TAK-875DRUG -
GlimepirideDRUG -
PlaceboDRUG -
SitagliptinDRUGSitagliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
TAK-875 and SitagliptinDRUGTAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * The participant is an outpatient. * The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: * The participant has any serious cardiac disease, serious cerebro...

Countries:JapanUnited StatesGuatemalaMexico
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Frequently asked questions about TAK-875

What is TAK-875 used for?

TAK-875 is an investigational small molecule being developed for type 2 diabetes mellitus. It has been studied in clinical trials for its effects on blood sugar control, including in combination with sitagliptin, and in long-term studies for diabetes management.

Who makes TAK-875?

TAK-875 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has sponsored clinical trials of the drug in patients with type 2 diabetes.

What phase is TAK-875 in?

TAK-875 has completed Phase 3 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. Its development program includes completed Phase 1, Phase 2, and Phase 3 studies.

What clinical trials has TAK-875 been in?

TAK-875 has been studied in several completed trials. NCT00949091 examined its pharmacokinetics and pharmacodynamics in type 2 diabetes. NCT01007097 and NCT01414920 assessed efficacy and safety, including with sitagliptin. NCT01433406 was a long-term study in diabetes.

How does TAK-875 work?

TAK-875 is a small molecule developed for type 2 diabetes. Its specific molecular target has not been disclosed in the available clinical trial information. The drug has been evaluated for its ability to improve glycemic control in diabetic patients.

Is TAK-875 the same as any other drug?

TAK-875 is the only name provided for this investigational drug. No alternative names have been identified in the clinical trial records. It is distinct from other diabetes medications studied in combination with it, such as sitagliptin.