NCT04885712已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Changes in HbA1c
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
- •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
- •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
- •Those who have been administered with obesity drugs (e.g., phentermine, phendimetrazine, diethylpropion, and mazindol) within 12 weeks as of Visit
- •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
- •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.
研究组 & 干预措施
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
干预措施: Metformin≥1000mg (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
干预措施: Pioglitazone 15mg (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
干预措施: Pioglitazone 30mg Placebo (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
干预措施: Dapagliflozin 10mg (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
干预措施: Metformin≥1000mg (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
干预措施: Pioglitazone 30 mg (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
干预措施: Pioglitazone 15mg Placebo (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
干预措施: Dapagliflozin 10mg (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Active Comparator
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
干预措施: Metformin≥1000mg (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Active Comparator
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
干预措施: Pioglitazone 15mg Placebo (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Active Comparator
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
干预措施: Pioglitazone 30mg Placebo (Drug)
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Active Comparator
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
干预措施: Dapagliflozin 10mg (Drug)
结局指标
主要结局
Changes in HbA1c
时间窗: 24th week
Changes in HbA1c at the 24th week after the administration of investigational products from the baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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