NCT05970237

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

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

First Submitted

Initial submission to the registry

July 24, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

July 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

July 24, 2023

Last Update Submit

September 11, 2025

Conditions

Diabetes MellitusHypertension

Outcome Measures

Primary Outcomes (2)

  • Target blood pressure control rate

    12weeks after administration

  • Target blood glucose achievement rate

    12weeks after administration

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Shinyoung Oh

CONTACT

+82-2-708-8000syoh@boryung.co.kr

Study Design

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

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 1, 2023

Study Start

July 26, 2023

Primary Completion

October 21, 2025

Study Completion

October 21, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)