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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Drug: DW6012(Dasidiem tab. 10/100mg)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Kyung Hee University Hospital at Gangdong
    • Contact: Kyung Hee University Hospital at Gangdong; Phone Number: 82+2-440-7000; Email: cri@khnmc.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dasidiem 10/100mg; Dapagliflozin 10mg +sitagliptin 100mg combination drug	Drug: DW6012(Dasidiem tab. 10/100mg); Once a day, Oral administration; Other Names: Piotazone tab.; Sitdiem tab. 100mg
Active Comparator: sitdiem 100mg, Piotazone15mg; sitagliptin 100mg, Pioglitazone 15mg	Drug: DW6012(Dasidiem tab. 10/100mg); Once a day, Oral administration; Other Names: Piotazone tab.; Sitdiem tab. 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variance in HbA1c from baseline to 24 weeks on study drug	Change in HbA1c	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving HbA1c of 7.0% or 6.5% or less at 12 and 24 weeks post study drug administration compared to baseline	Percentage of patients achieving HbA1c of 7.0% or 6.5% or less	12, 24 weeks
Percentage of subjects prescribed an rescue drug during this study	rescue drug	during 24weeks(study duration/per subject)
Variance in HbA1c from baseline to 12 weeks on study drug	Change in HbA1c	12 weeks
Variance in FPG from baseline to 12, 24 weeks on study drug	Change in Fasting Plasma Glucose(FPG)	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	Change in TC, TG, HDL, LDL	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	FLI(Fatty Liver Index)= 1/(1+exp(-x))×100 HSI(Hepatic steatosis index) = 8×ALT/AST+BMI(+2, if type 2 diabetes yes, +2 if female)	12, 24 weeks
Variance in Kidney value from baseline to 12, 24 weeks on study drug	Kidney value: eGFR(CKD-EPI fomulation) ACR(Albumin to Creatine ratio), Creatinine	12, 24 weeks
Variance in body weight from baseline to 12, 24 weeks on study drug		12, 24 weeks
Variance in Insulin from baseline to 12, 24 weeks on study drug		12, 24 weeks
Variance in waist measurement from baseline to 12, 24 weeks on study drug		12, 24 weeks
Variance in BMI from baseline to 12, 24 weeks on study drug		12, 24 weeks
Variance in blood pressure from baseline to 12, 24 weeks on study drug		12, 24 weeks
Variance in HOMA-IR, HOMA-β(Glucose in Molar Units mmol/L) from baseline to 12, 24 weeks on study drug		12, 24 weeks
Variance in c-peptide from baseline to 12, 24 weeks on study drug		12, 24 weeks

Collaborators and Investigators

• Sponsor: Dong Wha Pharmaceutical Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dapagliflozin; Pioglitazone; DPP-4 inhibitor
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: DW6012-IV-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No