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
- Conditions
- Type2 Diabetes
- Interventions
- Registration Number
- NCT04885712
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- 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 Mellitus Inadequately Controlled with Metformin and Dapagliflozin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 378
- 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.
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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.)
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Medication compliance is <70% or >120% for each BR3003D, BR3003C, BR3003A-2, and BR3003B-2 during the Run-in period at Visit 2.
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Patients with other types of diabetes instead of type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, or congenital renal glycosuria).
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Patients with uncontrolled, severe diabetic complications (e.g., proliferative diabetic retinopathy uncontrolled despite medication and severe diabetic neuropathy)
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Those who suffered from acute or chronic metabolic acidosis within 3 months as of Visit 1, including lactic acidosis and diabetic ketoacidosis.
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Those with > 40 kg/m2 of BMI measured at Visit 1.
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Those with uncontrolled hypertension at Visit 1 or Visit 2 (SBP > 180 mmHg or DBP > 110 mmHg).
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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
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Those with heart failure (NYHA class II~IV) or who had suffered from heart failure.
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Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery;
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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
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Those with a history of malignant tumor within 5 years as of Visit 1
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Those who have a clinically significant liver disease
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Those who have a clinically significant renal disease
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Those with clinically significant hematuria detected at Visit 1 or Visit 2
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Those with chronic diseases requiring the continued use of systemic steroid or immunosuppressants (oral administration, injection, or inhalation).
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Patients with pituitary insufficiency or adrenal insufficiency.
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Those with clinically significant severe infection or trauma based on an investigator's judgement.
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Patients with AIDS.
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Patients with acute or chronic diseases that may cause histotoxic hypoxia such as respiratory failure and shock.
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Those who need treatment due to dehydration caused by persistent diarrhea and vomiting or at a risk of fluid volume depletion.
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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.
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Those with history of alcohol or drug abuse within 1 year as of Visit 1.
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Those who had allergic reaction to main ingredients or components of the investigational products.
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Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
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Females who are pregnant or breastfeeding.
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Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
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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
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Those who are judged unsuitable for the study by a principal investigator or investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo Metformin≥1000mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo Pioglitazone 15mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo Pioglitazone 30mg Placebo Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo Dapagliflozin 10mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo Metformin≥1000mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo Dapagliflozin 10mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo Metformin≥1000mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo Pioglitazone 15mg Placebo Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo Pioglitazone 30mg Placebo Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo Dapagliflozin 10mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo Pioglitazone 30 mg Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo Pioglitazone 15mg Placebo Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
- Primary Outcome Measures
Name Time Method Changes in HbA1c 24th week Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of