Clinical trial NCT06875193: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type2diabetes
Keywords: Dapagliflozin
Pioglitazone
DPP-4 inhibitor
Lead sponsor: Dong Wha Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-13
Enrollment: 196
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

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

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

Primary outcomes:
measure: Variance in HbA1c from baseline to 24 weeks on study drug
timeFrame: 24 weeks
Secondary outcomes:
measure: Variance in HbA1c from baseline to 12 weeks on study drug
timeFrame: 12 weeks
measure: Variance in FPG from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: Variance in TC(mg/dL), TG(mg/dL), HDL(mg/dL), LDL(mg/dL) from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: 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
timeFrame: 12, 24 weeks
measure: Variance in Kidney value from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: Variance in body weight from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: 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
timeFrame: 12, 24 weeks
measure: Variance in Insulin from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: Percentage of subjects prescribed an rescue drug during this study
timeFrame: during 24weeks(study duration/per subject)
measure: Variance in waist measurement from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: Variance in BMI from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: Variance in blood pressure from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: Variance in HOMA-IR, HOMA-β(Glucose in Molar Units mmol/L) from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
measure: Variance in c-peptide from baseline to 12, 24 weeks on study drug
timeFrame: 12, 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
References: