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

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)

Eligibility

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

Conditions2

Interventions1

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