None listed
Conditions
Interventions
Drug : The study subjects will orally administer one tablet of Dualglow Tab.(10 mg or 15 mg) once daily in combination with Metformin (=1000 mg/day) for 24 weeks.
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 or older at the time of written consent 2. Diagnosed with type 2 diabetes 3. Concurrently administered Metformin (=1000 mg/day) along with Dapagliflozin (10 mg/day), Empagliflozin (25 mg/day), or a DPP-4 inhibitor at the maximum daily dosage per ingredient (Sitagliptin 100 mg/day, Vildagliptin 100 mg/day, Saxagliptin 5 mg/day, Linagliptin 5 mg/day, Gemigliptin 50 mg/day, Teneligliptin 20 mg/day, Alogliptin 25 mg/day, Evogliptin 5 mg/day, Anagliptin 200 mg/day) for at least 8 weeks prior to enrollment, with HbA1c =7% 4. Agrees to adhere to an exercise and diet regimen during the study period 5. Voluntarily provided written consent to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1. Individuals with a history of hypersensitivity to biguanides, SGLT2 inhibitors, or thiazolidinediones 2. Individuals meeting any of the following criteria: 1) Known hypersensitivity to this medication or any of its ingredients 2) History of heart failure (NYHA class III-IV) within the past 6 months 3) Active bladder cancer or history of bladder cancer 4) Taking medications associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen, valproate) 5) Significant alcohol consumption (exceeding 210g per week for men or 140g per week for women in the past 2 years) 6) Chronic Hepatitis B or C 7) Severe renal impairment (including patients on dialysis) 8) Diabetic ketoacidosis, diabetic coma or pre-coma, or type 1 diabetes 9) Severe infections, severe trauma, or perioperative patients (where insulin administration is preferable for glucose management) 10) Uninvestigated macroscopic hematuria 11) Pregnant women or women who may be pregnant 12) Patients with genetic disorders, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, due to the lactose content in this medication 3. Patients with diabetes other than type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, congenital renal diabetes) 4. Individuals with more than a 10% body weight change within the past 3 months and currently experiencing polyuria or polydipsia 5. Individuals who have taken investigational drugs within the last 12 weeks or are currently enrolled in another clinical trial - Participation may be allowed if deemed by the investigator to not impact the efficacy or safety of this clinical trial (e.g., observational or retrospective studies) 6. Individuals with a history of or expected need for ongoing use of the following medications during the trial period: - Weight-loss drugs within the past 12 weeks - Diabetes treatments other than metformin, dapagliflozin, empagliflozin, or DPP-4 inhibitors within the past 8 weeks - Systemic corticosteroids (oral, injectable, inhaled) within the past 2 weeks, exceeding 30 mg/day of prednisolone - Diuretics with dose adjustments within the past 8 weeks (dose reductions are permitted) 7. Individuals deemed unsuitable for participation by the principal investigator or responsible clinician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (%) from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c (%) from baseline;Change in fasting plasma glucose (FPG) from baseline;Proportion of subjects achieving HbA1c <7.0% or <6.5%;Change in Hepatic Steatosis Index (HSI) from baseline;Change in fibrosis-4 (FIB-4) index from baseline;Liver fibrosis assessment from baseline;Changes in body weight and BMI from baseline;Incidence and characteristics of adverse events following Dualglow tab. 10/15 mg administration;Physical examination;Vital signs;Laboratory tests;Changes in InBody metrics from baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactBongsoo Cha
Yonsei University Health System, Severance Hospital
Outcome results
None listed