The Prescription Patterns and Clinical Efficacy of Tenero... | NCT06188234

Studies
The Prescription Patterns and Clinical Efficacy of Tenero Tab/Tenero M SR Tab

NCT06188234

Sponsor

Hanlim Pharm. Co., Ltd.

Status

Unknown status

Last Update Posted

Feb 15, 2024Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 27, 2022Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Dec 18, 2023

First Submission Date that Met QC Criteria

Dec 18, 2023

First Posted Date

Jan 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2024

Last Update Posted Date

Feb 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This study is to observe the clinical efficacy by analyzing the prescription patterns in routine clinical practice and changes in HbA1c, FPG, PP2G, etc., of patients prescribed with Tenero Tab/Tenero M SR Tab for diabetes treatment. Additionally, the study intends to assess patient satisfaction based on these observations.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yeonhwa Kim	Contact	82-2-3489-6163		yh@hanlim.com

Overall Officials

Name	Affiliation	Role
Seokgi Yoon	CHEONAN ENDO MEDICAL CLINIC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cheonan Endo Medical Clinic	Recruiting	Cheonan			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided