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Clinical Trials/NCT06495281
NCT06495281
Completed
Not Applicable

A Observational Study to Evaluate Effectiveness, Safety of Triple Combination Therapy of Zemidapa and Metformin in Patients With Type 2 DM Who Received Double or Triple Combination Therapy Including DPP4-inhibitor Other Than Gemigliptin

LG Chem1 site in 1 country2,044 target enrollmentOctober 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
LG Chem
Enrollment
2044
Locations
1
Primary Endpoint
change from baseline of HbA1c at 12 weeks
Status
Completed
Last Updated
last month

Overview

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of Zemidapa Tab. and Metformin in patients with type 2 diabete mellitus

Registry
clinicaltrials.gov
Start Date
October 26, 2023
End Date
December 3, 2025
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Sponsor
LG Chem
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • type 2 DM Patients who are receiving one of the following three therapies during which the patients are prescribed with Zemidapa Tab. for the first time at the discretion of the attending physician:
  • Double combination therapy (Metformin and a DPP-4 inhibitor other than Gemigliptin)
  • Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and a SGLT-2 inhibitor)
  • Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and Sulfonylurea \[SU\])
  • patients with HbA1c results and who signed the written consent form

Exclusion Criteria

  • \- Patients contraindicated for the approved use of Zemidapa Tab. or have participated in another clinical study within 12 weeks

Outcomes

Primary Outcomes

change from baseline of HbA1c at 12 weeks

Time Frame: baseline, 12 weeks

Secondary Outcomes

  • the rate of subjects who reached the target value of less than 7% HbA1c(12 weeks)

Study Sites (1)

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