Clinical study to evaluate the efficacy and safety of Pioglitazone co-administration in patients with type II diabetes with insufficient glycemic control with Metformin and Empagliflozin combination therapy
- Conditions
- Type 2 diabetes mellitus (T2DM)MedDRA version: 21.1Level: LLTClassification code: 10045242Term: Type II diabetes mellitus Class: 10027433Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-508924-36-00
- Lead Sponsor
- Celltrion Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 582
Adults* at the time of signing the Informed Consent Form (ICF) * The age of majority is different in countries, and the current country-specific requirements apply. Currently, the age of majority is 19 years or older and 18 years and older in Korea and Poland, respectively., Diagnosed with T2DM, Following HbA1c concentration* at Visit 1 ? Drug-naïve** or prior treatment with Metformin*** monotherapy: 7.5% = HbA1c = 11% ? Prior treatment with co-administration of Metformin*** and other oral hypoglycemic agents****: 7.0% = HbA1c = 11% * Based on the test result performed by the study site at Visit 1 (the test result performed by the study site within 2 weeks is allowed.) ** Subjects who have not received any oral hypoglycemic agents within 12 weeks of Visit 1. *** Subjects who have not received Metformin or who have received less than 1,000 mg as a fixed-dose combination (FDC) or combination therapy at Visit 1 may participate in this study if it is appropriate to prescribe Metformin 1,000 mg as a new dose or to increase the dose above 1,000 mg, at the discretion of the Investigator. In this case, subjects need to enter an 8- week stabilization and washout period with the increased dosage. However, if subjects have received Metformin over 1,000 mg, they may maintain the existing dose administered prior to the Screening. If subjects need to change the dosage of Metformin, they need to enter stabilization and washout period. **** Subjects who have received oral hypoglycemic agents (except oral GLP-1 analogues) or with components or drugs of the same class as the IP or the background therapy (biguanides, SGLT2 inhibitors, and thiazolidinediones) may participate in the study after the stabilization and washout period and the run-in period if they meet the inclusion/exclusion criteria., Subjects who meet the following at Visit 2 ? Subjects who have received the background therapy without change in the dosage, administration method, and dosage form during the stabilization and washout period (12 weeks for drug naïve, 8 weeks for the others) ? Subjects who do not need to change the background therapy at the discretion of the investigator ? Measured as 7.0% = HbA1c = 11% by the central laboratory at Visit 2, Body mass index (BMI) = 45.0 kg/m2 at Visit 1 and Visit 3, Compliance of overall medication in between 70% and 120% inclusive, at each Visit 2 and Visit 3, Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study
Diagnosed with other types of diabetes than T2DM (type 1 diabetes, secondary diabetes, or congenital nephrogenic diabetes insipidus, etc.), Immune deficiency syndrome (AIDS) or history of positive HIV-1, History of gross hematuria or current symptom of clinically significant hematuria, Hypopituitarism or adrenal insufficiency, History of genetic disorders, including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc., Following conditions with a clinically significant liver disease: ? AST or ALT > 3 times the upper limit of normal ? Total bilirubin > 2 times the upper limit of normal ? Hepatitis requiring antiviral treatment ? Liver cirrhosis or liver failure, Following conditions with a clinically significant kidney disease: ? eGFR* < 45 ml/min/1.73 m2 ? eGFR* < 60 ml/min/1.73 m2: For those who received more than Metformin 1,000 mg at Visit 1 * eGFR can be calculated using either the Modification of Diet in Renal Disease (MDRD) equation or the equation of the study site., Uncontrolled severe complications of diabetes (e.g., proliferative diabetic retinopathy that is uncontrolled by medication, and severe diabetic neuropathy) [Exception: If subjects are stable (e.g., can be controlled with a stable dose of medication), they may be enrolled at the discretion of the investigator.], History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy (biguanides, SGLT2 inhibitors, and thiazolidinediones), History of acute or chronic metabolic acidosis including lactic acidosis and diabetic ketoacidosis within 12 weeks of Visit 1, History of cardiovascular diseases of New York Heart Association (NYHA) Class II or higher (e.g., heart failure, unstable angina, arrhythmia, myocardial infarction, transient ischemic attack, and stroke, coronary artery bypass graft, or coronary intervention) within 6 months of Visit 1 (Exception: If subjects have the history of heart failure longer than 6 months, they may participate, only under the full recovery or in stable condition currently. However, if subjects have the history of heart failure of NYHA Class II or higher, they will be excluded even if the event occurred before 6 months ago.), History of diabetic coma or precoma within 1 year of Visit 1, Following conditions with a history of gastrointestinal disorders or surgical operation which may affect the absorption, distribution, metabolism, and excretion of the IP: ? Active gastritis or gastric ulcer uncontrolled with medications ? Gastrointestinal/rectal bleeding, biliary obstruction or cessation of bile secretion, urinary tract obstruction ? Acute or chronic pancreatitis ? Active inflammatory bowel diseases (e.g., Crohn’s disease, and ulcerative colitis) within 12 months of Visit 1 ? History of any types of bariatric surgery within 2 years of Visit 1 ? History of any major gastrointestinal surgery such as total gastrectomy, total proctocolectomy, enterectomy, gastroenterostomy, and gastric bypass surgery ? History of pancreatectomy ? Conditions requiring treatment for dehydration due to persistent diarrhea, vomiting, etc., or at risk of body fluid depletion, History of surgery requiring general anesthesia (except for surgery not requiring dietary restrictions) within 4 weeks of Visit 1, or plan for such surgery within 4 weeks after the end of study (Exception: Surgeries that do not have a significant impact on systemic metabolism, such as endoscopic surgery, dental s
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method