Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
Lead Sponsor:
Boryung Pharmaceutical Co., Ltd
Conditions:
Type2 Diabetes
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or Pioglitazone 30mg Add-on in Patients with Type 2 Diabetes Melli...
Eligibility Criteria
Inclusion
- Those who voluntarily signed the informed consent to participate in this study.
- Adults aged 19 years or older.
- Those diagnosed with type 2 diabetes mellitus.
- Subjects taking constant doses of ≥1000mg of Metformin and 10 mg of Dapagliflozin for more than 8 weeks at Visit 1 (regardless of dosage forms (immediate-release and sustained-release) and single agent or combination drug.)
- Subjects with 7% ≤ HbA1c ≤ 10.5% at Visit 1 and Visit 2
- Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.
Exclusion
- Uncontrolled hyperglycemia at Visit 1 or Visit 2 (subjects with FPG \> 270 mg/dL as a result of the test conducted by the study institution.)
- Medication compliance is \<70% or \>120% for each BR3003D, BR3003C, BR3003A-2, and BR3003B-2 during the Run-in period at Visit 2.
- Patients with other types of diabetes instead of type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, or congenital renal glycosuria).
- Patients with uncontrolled, severe diabetic complications (e.g., proliferative diabetic retinopathy uncontrolled despite medication and severe diabetic neuropathy)
- Those who suffered from acute or chronic metabolic acidosis within 3 months as of Visit 1, including lactic acidosis and diabetic ketoacidosis.
- Those with \> 40 kg/m2 of BMI measured at Visit 1.
- Those with uncontrolled hypertension at Visit 1 or Visit 2 (SBP \> 180 mmHg or DBP \> 110 mmHg).
- Those diagnosed with cardiovascular diseases (myocardial infarction, stroke, unstable angina, and transient ischemic attack (TIA)) or undergo revascularization within 3 months as of Visit 1
- Those with heart failure (NYHA class II\~IV) or who had suffered from heart failure.
- Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery;
- Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1 or who are scheduled to receive such surgery within 4 weeks after the study ends
- Those with a history of malignant tumor within 5 years as of Visit 1
- Those who have a clinically significant liver disease
- Those who have a clinically significant renal disease
- Those with clinically significant hematuria detected at Visit 1 or Visit 2
- Those with chronic diseases requiring the continued use of systemic steroid or immunosuppressants (oral administration, injection, or inhalation).
- Patients with pituitary insufficiency or adrenal insufficiency.
- Those with clinically significant severe infection or trauma based on an investigator's judgement.
- Patients with AIDS.
- Patients with acute or chronic diseases that may cause histotoxic hypoxia such as respiratory failure and shock.
- Those who need treatment due to dehydration caused by persistent diarrhea and vomiting or at a risk of fluid volume depletion.
- Those who have been administered with the following drugs or expected to require the continued administration during the study period:
- Those administered with systemic steroid agents (Prednisolone, \>30 mg/day) within 2 weeks as of Visit 1.
- Those being administered with thyroid medications and whose dose has been modified within 6 weeks as of Visit 1 (however, dose reduction is accepted.)
- Those being administered with diuretics and whose dose has been modified within 8 weeks as of Visit 1 however, dose reduction is accepted.)
- Those who have been administered with antidiabetics other than Metformin and Dapagliflozin within 8 weeks as of Visit 1.
- Those who have been administered with obesity drugs (e.g., phentermine, phendimetrazine, diethylpropion, and mazindol) within 12 weeks as of Visit 1.
- Those who need to take prohibited concomitant medications stated here during the study period.
- Those with history of alcohol or drug abuse within 1 year as of Visit 1.
- Those who had allergic reaction to main ingredients or components of the investigational products.
- Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
- Females who are pregnant or breastfeeding.
- Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
- Those who are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks as of Visit 1
- Those who are judged unsuitable for the study by a principal investigator or investigators.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2023
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT04885712
Start Date
May 28 2021
End Date
March 10 2023
Last Update
May 24 2023
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea