NCT03042325

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when given as monotherapy or add on therapy in participants who are on standard care for management of Type 2 Diabetes Mellitus (T2DM).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

July 30, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

6 months

First QC Date

February 1, 2017

Last Update Submit

October 18, 2017

Conditions

Diabetes Mellitus, Type 2

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

  • Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.

    Baseline up to 30 days after the last dose of study drug (up to 30 weeks)

  • Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs

    An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.

    Baseline up to 30 days after the last dose of study drug (up to 30 weeks)

  • Change from Baseline in Glycosylated Haemoglobin (HbA1c) at Weeks 13 and 26

    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 weeks 13 and 26 relative to Baseline.

    Baseline and Weeks 13 and 26

  • Percentage of Participants with Glycosylated Hemoglobin < 7.0%

    Clinical response at Weeks 13 and 26 will be assessed by the percentage of participants with HbA1c less than 7%.

    Weeks 13 and 26

Study Arms (1)

Alogliptin

EXPERIMENTAL

Alogliptin 25 mg, tablets, orally, once, daily for 26 weeks in addition to standard care for the management of Type 2 Diabetes Mellitus (T2DM). Dose will be adjusted as per creatinine clearance \[CrCl\].

Drug: Alogliptin

Interventions

AlogliptinDRUG

Alogliptin tablets

Also known as: SYR-322, Nesina
Alogliptin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Participants with T2DM who are dipeptidyl peptidase-4 (DPP-4) inhibitor-naive; including alogliptin.

You may not qualify if:

  • Has contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information.
  • Participants treated with alogliptin tablets outside the approved label/ prescribing information.
  • Has end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) \<15 mL/min or requiring hemodialysis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 3, 2017

Study Start

July 30, 2017

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

October 20, 2017

Record last verified: 2017-10