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

Official title

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

Overview

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

Interventions

• Drug DW6012(Dasidiem tab. 10/100mg)
  Once a day, Oral administration

Primary outcome measures

• Variance in HbA1c from baseline to 24 weeks on study drug [Time frame: 24 weeks]

Secondary outcome measures (12)

• Variance in HbA1c from baseline to 12 weeks on study drug [Time frame: 12 weeks]
• Variance in FPG from baseline to 12, 24 weeks on study drug [Time frame: 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 [Time frame: 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 [Time frame: 12, 24 weeks]
• Variance in Kidney value from baseline to 12, 24 weeks on study drug [Time frame: 12, 24 weeks]
• Variance in body weight from baseline to 12, 24 weeks on study drug [Time frame: 12, 24 weeks]
• 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 [Time frame: 12, 24 weeks]
• Variance in Insulin from baseline to 12, 24 weeks on study drug [Time frame: 12, 24 weeks]
• Percentage of subjects prescribed an rescue drug during this study [Time frame: during 24weeks(study duration/per subject)]
• Variance in waist measurement from baseline to 12, 24 weeks on study drug [Time frame: 12, 24 weeks]
• Variance in BMI from baseline to 12, 24 weeks on study drug [Time frame: 12, 24 weeks]
• Variance in blood pressure from baseline to 12, 24 weeks on study drug [Time frame: 12, 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

South Korea · 1 center

• Kyung Hee University Hospital at Gangdong — Seoul

Identifiers

NCT: NCT06875193 · DW6012-IV-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗