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

NCT06875193 | Recruiting Phase 4

• 1 other identifier: DW6012-IV-2
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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)

Conditions

Type2diabetes

Keywords

Dapagliflozin; Pioglitazone; DPP-4 inhibitor

Outcome Measures

Primary Outcomes (1)

• Variance in HbA1c from baseline to 24 weeks on study drug

  Change in HbA1c

  24 weeks

Secondary Outcomes (14)

• Variance in HbA1c from baseline to 12 weeks on study drug

  12 weeks

• Variance in FPG from baseline to 12, 24 weeks on study drug

  12, 24 weeks

• Variance in TC(mg/dL), TG(mg/dL), HDL(mg/dL), LDL(mg/dL) from baseline to 12, 24 weeks on study drug

  12, 24 weeks

• Variance in FLI(Fatty Liver Index), AST, ALT, r-GTP, ALP, HSI(Hepatic steatosis index), Total bilirubin, Albumin, Protein from baseline to 12 and 24 weeks after study drug administration

  12, 24 weeks

• Variance in Kidney value from baseline to 12, 24 weeks on study drug

  12, 24 weeks

Study Arms (2)

Dasidiem 10/100mg

EXPERIMENTAL

Dapagliflozin 10mg +sitagliptin 100mg combination drug

Drug: DW6012(Dasidiem tab. 10/100mg)

sitdiem 100mg, Piotazone15mg

ACTIVE COMPARATOR

sitagliptin 100mg, Pioglitazone 15mg

Drug: DW6012(Dasidiem tab. 10/100mg)

Interventions

DW6012(Dasidiem tab. 10/100mg) DRUG

Once a day, Oral administration

Also known as: Piotazone tab., Sitdiem tab. 100mg

Dasidiem 10/100mg; sitdiem 100mg, Piotazone15mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong Wha Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 13, 2025
• Study Start: May 28, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)