NCT06188234

Brief Summary

This study is to observe the prescription patterns and clinical efficacy of patients prescribed with Tenero Tab/Tenero M SR Tab for diabetes treatment in routine clinical practice.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress98%
Dec 2022Jun 2026

Study Start

First participant enrolled

December 27, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

3.4 years

First QC Date

December 18, 2023

Last Update Submit

February 13, 2024

Conditions

Diabetes Mellitus, Type 2

Keywords

Metformin HCITeneligliptin hydrochloride

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c at 6 months of prescribing Tenero Tablet/Tenero Emextended Release Tablet compared to baseline

    Change in HbA1c at 6 months of prescribing Tenero Tablet/Tenero Emextended Release Tablet compared to baseline

    after 6 months of prescription for Tenero Tab/Tenero M SR Tab compared to baseline

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients prescribed Tenero Tab/Tenero M SR Tab for diabetes treatment.

You may qualify if:

  • Adults over 19 years of age
  • Individuals diagnosed with type 2 diabetes.
  • Individuals who, at the clinical discretion, are prescribed Tenero Tab or Tenero M SR Tab for the purpose of diabetes treatment for the first time.
  • Individuals who have voluntarily provided written consent to participate in this study.

You may not qualify if:

  • Pregnant or breastfeeding women.
  • Individuals who are contraindicated according to the approved indications of Tenero Tab/Tenero M SR Tab.
  • Other cases where the principal investigator and study personnel deem individuals ineligible for participation in this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheonan Endo Medical Clinic

Cheonan, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Seokgi Yoon

    CHEONAN ENDO MEDICAL CLINIC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeonhwa Kim

CONTACT

82-2-3489-6163yh@hanlim.com

Study Design

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

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 3, 2024

Study Start

December 27, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

KR(1)