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NCT06188234 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Observational Study on the Prescription Patterns and Clinical Efficacy of Tenero Tab/Tenero M SR Tab in Korean Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06188234
Other study ID # HL-TNL/M-401
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 27, 2022
Est. completion date June 2026

Study information
Verified date February 2024
Source Hanlim Pharm. Co., Ltd.
Contact Yeonhwa Kim
Phone 82-2-3489-6163
Email yh@hanlim.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3000
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Adults over 19 years of age 2. Individuals diagnosed with type 2 diabetes. 3. 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. 4. Individuals who have voluntarily provided written consent to participate in this study. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Individuals who are contraindicated according to the approved indications of Tenero Tab/Tenero M SR Tab. 3. Other cases where the principal investigator and study personnel deem individuals ineligible for participation in this clinical trial.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Cheonan Endo Medical Clinic Cheonan

Sponsors (1)
Lead Sponsor Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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