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DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes | Clinical Trials | Clareo Health

RECRUITINGPHASE4

DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes

Key Finding of DM Treatment with Combination, a MuLticenter, Randomized, Parallel, Gathering Information of Phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone Add-on to Metformin and DPP-4 Inhibitor in Patients with Type 2 Diabetes

NCT06875193•Dong Wha Pharmaceutical Co. Ltd.

View on ClinicalTrials.gov

Summary

Key finding of DM Treatment with combination, A MuLticenter, Randomized, Parallel, Gathering Information of phase 4 Trial to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone add-on to Metformin and DPP-4 inhibitor in Patients with Type 2 Diabetes Who Have Inadequate Glycaemic Control on a Background Combination of Metformin and DPP-4 inhibitor(KLIMT Study)

Detailed Description

This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with type 2 diabetes who are 19 years of age or older at the date of written consent
•Subjects who Receiving a stable dose of metformin and a DPP-4 inhibitor for at least the last 8 weeks at the time of screening
•HbA1c ≤ 7.0% ≤ HbA1c \< 10% at time of screening
•BMI ≤ 18.5 kg/m2 ≤ 40 kg/m2 at time of screening
•Subjects fully explained and understood the purpose and methods of this study and voluntarily gave written informed consent

Exclusion Criteria

•Patients with type 1 diabetes
•Have a BMI \> 40 kg/m2
•Subjects who have moderate (Stage 3b) or severe kidney disease or an estimated glomerular filtration rate (eGFR, using the CKD-EPI formula) \< 45 mL/min/1.73 m2
•Patients with end stage renal disease or patients on dialysis
•Patients with uncontrolled heart failure (NYHA class III - IV)
•Patients with history of uncontrolled arrhythmia, myocardial infarction, unstable angina, coronary artery bypass graft surgery, cerebrovascular disease within 24 weeks prior to the screening visit
•Patients with acute or chronic metabolic acidosis, including lactic acidosis, diabetic ketoacidosis (DKA) with or without coma, and patients with a history of ketoacidosis
•Patients with diabetic coma or precoma
•Patients with a history of severe hypoglycemia while taking metformin and DPP-4 inhibitors.
•Patients with hematuria
+14 more criteria

Locations (1)

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Key Dates

Start Date

May 28, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

March 17, 2025

Enrollment

196

ESTIMATED participants

Conditions

Type2diabetes

Interventions

DW6012(Dasidiem tab. 10/100mg)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE

Non-weight Bearing Exercise for Accelerated Healing of Diabetic Foot Ulcers

Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF)

Depletion of Liver Fat in Type 2 Diabetes

Digital Care for Holistic Health in Older Adults With Diabetes and Multimorbidity

The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older