NCT01964963

Brief Summary

The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19,192

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

May 9, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

6 years

First QC Date

October 15, 2013

Results QC Date

July 27, 2018

Last Update Submit

November 12, 2019

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants Who Had One or More Adverse Events

    Up to Month 36

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    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 final assessment point (up to Month 36) relative to baseline.

    Baseline, and final assessment point (up to Month 36)

Secondary Outcomes (1)

  • Change From Baseline in Fasting Blood Glucose

    Baseline, and final assessment point (up to Month 36)

Study Arms (1)

Alogliptin

Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.

Drug: Alogliptin

Interventions

AlogliptinDRUG

Alogliptin tablets

Also known as: Nesina, SYR-322
Alogliptin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with mild type 2 diabetes mellitus who have been examined at a medical institution

You may qualify if:

  • Patients with Haemoglobin A1c (HbA1c) \[Japan Diabetes Society (JDS) value\] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.

You may not qualify if:

  • Patients contraindicated for alogliptin.
  • Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
  • Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
  • Patients with a history of hypersensitivity to any ingredient of alogliptin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2013

First Posted

October 17, 2013

Study Start

August 3, 2011

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

November 21, 2019

Results First Posted

May 9, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Locations

JP(1)