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

NCT ID: NCT06875193

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-28
• Study Completion Date: 2025-12-31

Brief 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

Conditions

Type2diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dasidiem 10/100mg

Dapagliflozin 10mg +sitagliptin 100mg combination drug

Group Type: EXPERIMENTAL

DW6012(Dasidiem tab. 10/100mg)

Intervention Type: DRUG

Once a day, Oral administration

sitdiem 100mg, Piotazone15mg

sitagliptin 100mg, Pioglitazone 15mg

Group Type: ACTIVE_COMPARATOR

DW6012(Dasidiem tab. 10/100mg)

Intervention Type: DRUG

Once a day, Oral administration

Interventions

DW6012(Dasidiem tab. 10/100mg)

Once a day, Oral administration

Intervention Type: DRUG

Other Intervention Names

Piotazone tab.; Sitdiem tab. 100mg

Eligibility Criteria

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
• Patients who receiving treatment for thyroid dysfunction at the time of screening
• Malnourished, starving, or debilitated subjects
• Patients with pituitary insufficiency or adrenal insufficiency
• Patients with clinically significant hepatic disease with AST or ALT greater than 3 times the upper limit of normal
• Patients with severe infectious diseases, perioperative, or clinically significant trauma
• Have a history of substance abuse
• Patients receiving insulin or sulfonylurea, thiazolidinedione, SGLT2 inhibitor, GLP-1 receptor agonist within 8 weeks prior to the screening visit
• Patients who have received more than 2 consecutive weeks of corticosteroids within 8 weeks at the time of screening or who require treatment requiring repeated use of corticosteroids
• Patients with a history of malignancy within the last 5 years
• Participation in any other clinical trial within 12 weeks of screening in which an investigational drug or investigational medical device was administered or applied
• Pregnant and breastfeeding women
• Hypersensitivity to any of the drugs and components, including metformin, DPP-4 inhibitors, dapagliflozin, TZDs, sulfonylurea class of drugs, or any of the ingredients
• Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose mal-absorption.
• Any other person deemed by the investigator to be unsuitable for participation in the study

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong Wha Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Kyung Hee University Hospital at Gangdong

Role: primary

cri@khnmc.or.kr

82+2-440-7000

Other Identifiers

DW6012-IV-2

Identifier Type: -

Identifier Source: org_study_id