Status:
RECRUITING
DM Treatment to Evaluate the Efficacy and Safety of Dapagliflozin or Pioglitazone in Patients with Type 2 Diabetes
Lead Sponsor:
Dong Wha Pharmaceutical Co. Ltd.
Conditions:
Type2diabetes
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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...
Detailed Description
This is a Phase 4, multicenter, randomized, open-label, parallel clinical trial
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06875193
Start Date
May 28 2024
End Date
December 31 2025
Last Update
March 17 2025
Active Locations (1)
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1
Kyung Hee University Hospital at Gangdong
Seoul, South Korea