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Alogliptin Benzoate

Phase 3

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Takeda Pharmaceutical Company Limited|Last Updated: Oct 19, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment152

FDA Designations

No designations recorded

Clinical trial landscape

Alogliptin Benzoate · 1 trial · 1 indication

Phase 3 1
NCT02856113Phase 3 Alogliptin Pediatric StudyDiabetes Mellitus, Type 2
COMPLETED152 Analytics
PHASE3COMPLETED
Phase 3 Alogliptin Pediatric Study
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Baseline and Week 26

Change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) was collected at Week 26 relative to Baseline. Mixed model for repeated measures (MMRM) was used for the analysis.

Secondary Endpoints

Change From Baseline in HbA1c at Weeks 12, 18, 39 and 52
Baseline and Weeks 12, 18, 39 and 52
Percentage of Participants With Clinically Significant Physical Examination Findings
From Day 1 to end of treatment period (up to 52 weeks)
Percentage of Participants With Abnormal Vital Signs Values
From Day 1 to end of treatment period (up to 52 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORAlogliptin matching-placebo tablets, orally, once daily (QD) for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.
Alogliptin 25 mgEXPERIMENTALAlogliptin 25 mg tablets, orally, QD for 52 weeks and background antidiabetic therapy (metformin and/or insulin), if applicable, maintained at the same dose throughout the first 26 weeks of the treatment period.

Interventions

NameTypeDescription
Alogliptin BenzoateDRUGAlogliptin benzoate tablets.
PlaceboDRUGAlogliptin placebo-matching tablets.
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Eligibility Criteria

Age Range10 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: 1. Has a confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World Health Organization (WHO) criteria (laboratory determinations of fasting plasma glucose \[FPG\] greater than or equal to \[\>=\] 126 mg/dL, random glucose \>=200 mg/dL \[\>=11.10 mmol/L\], H...

Countries:United StatesBrazilIsraelItalyMexicoPolandRussia
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Frequently asked questions about Alogliptin Benzoate

What is Alogliptin Benzoate used for?

Alogliptin Benzoate is used for the treatment of Type 2 Diabetes Mellitus. It is a small molecule being developed by Takeda Pharmaceutical Company Limited for this metabolic condition. The drug is currently in Phase 3 clinical development, with one completed trial involving 152 patients.

What does Alogliptin Benzoate target?

Alogliptin Benzoate is a small molecule that targets the enzyme dipeptidyl peptidase-4 (DPP-4). By inhibiting DPP-4, it helps regulate blood sugar levels in patients with Type 2 Diabetes Mellitus. This mechanism is part of its therapeutic approach for managing the condition.

Who makes Alogliptin Benzoate?

Alogliptin Benzoate is developed by Takeda Pharmaceutical Company Limited, a company listed on the stock exchange under the ticker symbol TAK. The drug is being investigated for the treatment of Type 2 Diabetes Mellitus and is currently in Phase 3 clinical development.

What phase is Alogliptin Benzoate in?

Alogliptin Benzoate is in Phase 3 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug remains under investigation for this indication.

What clinical trials is Alogliptin Benzoate in?

Alogliptin Benzoate has one completed clinical trial, identified as NCT02856113, titled 'Phase 3 Alogliptin Pediatric Study'. This randomized, double-blind, placebo-controlled trial enrolled 152 participants with Type 2 Diabetes Mellitus across multiple countries, including the United States, Brazil, Israel, Italy, Mexico, Poland, and Russia.

Is Alogliptin Benzoate the same as Alogliptin?

Alogliptin Benzoate is a salt form of the drug alogliptin. The benzoate salt is often used in pharmaceutical formulations to improve stability or bioavailability. In clinical trials, the drug is referred to as Alogliptin Benzoate, and it is being studied for the treatment of Type 2 Diabetes Mellitus.