Study Stopped
Business Decision; No Safety Or Efficacy Concerns
Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
1 other identifier
observational
593
2 countries
11
Brief Summary
The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or alogliptin FDCs, in standard clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
11 active sites
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
First Submitted
Initial submission to the registry
December 8, 2016
CompletedFirst Posted
Study publicly available on registry
December 12, 2016
CompletedStudy Start
First participant enrolled
December 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2018
CompletedResults Posted
Study results publicly available
April 19, 2019
CompletedApril 19, 2019
January 1, 2019
1.1 years
December 8, 2016
January 23, 2019
January 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.
Baseline and Month 6
Secondary Outcomes (8)
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
Baseline and Month 6
Percentage of Participants With a Decrease in HbA1c Level by <7.0%
Baseline and Month 6
Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
Baseline and Month 6
Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
Baseline and Months 3 and 6
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
Baseline and Months 3 and 6
- +3 more secondary outcomes
Study Arms (1)
Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
Interventions
Alogliptin FDC with pioglitazone tablets
Alogliptin FDC with metformin tablets
Eligibility Criteria
Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.
You may qualify if:
- Has a diagnosis of T2DM.
- Has made the decision, along with his/her treating physician, to begin treatment with alogliptin or alogliptin fixed-dose combinations (FDCs).
- Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation of treatment with alogliptin or alogliptin FDCs.
- Alogliptin or alogliptin FDCs is prescribed according to the approved label for China and Hong Kong.
You may not qualify if:
- Has gestational diabetes or type 1 diabetes mellitus.
- Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or alogliptin FDCs treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (11)
Unknown Facility
Beijing, Beijing Municipality, China
Unknown Facility
Wuhan, Hubei, China
Unknown Facility
Dalian, Liaoning, China
Unknown Facility
Shenyang, Liaoning, China
Unknown Facility
Jinan, Shandong, China
Unknown Facility
Qingdao, Shandong, China
Unknown Facility
Taian, Shandong, China
Unknown Facility
Tai’an, Shandong, China
Unknown Facility
Tianjin, Tianjin Municipality, China
Unknown Facility
Sai Ying Pun, Hong Kong
Unknown Facility
Shatin, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
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
December 8, 2016
First Posted
December 12, 2016
Study Start
December 22, 2016
Primary Completion
January 26, 2018
Study Completion
January 26, 2018
Last Updated
April 19, 2019
Results First Posted
April 19, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach 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.