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Clinical Trials/NCT05970237
NCT05970237
Recruiting
N/A

A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Boryung Pharmaceutical Co., Ltd1 site in 1 country9,000 target enrollmentJuly 26, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Boryung Pharmaceutical Co., Ltd
Enrollment
9000
Locations
1
Primary Endpoint
Target blood pressure control rate
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

Registry
clinicaltrials.gov
Start Date
July 26, 2023
End Date
October 21, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.
  • Those who voluntarily signed a written personal information agreement to participate in this clinical study.
  • Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion Criteria

  • Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)
  • Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1)
  • Those who are expected to need insulin prescription during the study period
  • Pregnant women, breast-feeding women

Outcomes

Primary Outcomes

Target blood pressure control rate

Time Frame: 12weeks after administration

Target blood glucose achievement rate

Time Frame: 12weeks after administration

Study Sites (1)

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