NCT03555591

Brief Summary

The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with 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
3,198

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 1, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

5.5 years

First QC Date

June 1, 2018

Results QC Date

October 23, 2022

Last Update Submit

December 7, 2023

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Who Had One or More Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    36 months

  • Number of Participants Who Had One or More Adverse Drug Reactions

    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

    36 months

Secondary Outcomes (8)

  • Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)

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

  • Change From Baseline in Fasting Blood Glucose

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

  • Change From Baseline in Fasting Insulin Level

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

  • Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)

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

  • Change From Baseline in Fasting Glucagon

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

  • +3 more secondary outcomes

Study Arms (1)

Trelagliptin 100 mg

Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.

Drug: Trelagliptin

Interventions

TrelagliptinDRUG

Trelagliptin tablets

Also known as: Zafatek tablets
Trelagliptin 100 mg

Eligibility Criteria

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

Patients with type 2 diabetes mellitus in the routine clinical setting

You may qualify if:

  • Type 2 diabetes mellitus patients

You may not qualify if:

  • Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
  • Have severe infection, perioperative status, or serious trauma
  • Have severe renal impairment or on dialysis due to end-stage renal disease
  • Have a history of hypersensitivity to any ingredients of this drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

trelagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Study Director
Organization
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
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

June 1, 2018

First Posted

June 13, 2018

Study Start

May 1, 2016

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

December 12, 2023

Results First Posted

September 1, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
More information

Locations

JP(1)