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
Overview
- Phase
- Phase 3
- Intervention
- Metformin≥1000mg
- Conditions
- Type2 Diabetes
- Sponsor
- Boryung Pharmaceutical Co., Ltd
- Enrollment
- 378
- Locations
- 1
- Primary Endpoint
- Changes in HbA1c
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
Intervention: Metformin≥1000mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
Intervention: Pioglitazone 15mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
Intervention: Pioglitazone 30mg Placebo
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
Intervention: Dapagliflozin 10mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
Intervention: Metformin≥1000mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
Intervention: Pioglitazone 30 mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
Intervention: Pioglitazone 15mg Placebo
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
Intervention: Dapagliflozin 10mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
Intervention: Metformin≥1000mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
Intervention: Pioglitazone 15mg Placebo
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
Intervention: Pioglitazone 30mg Placebo
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
Intervention: Dapagliflozin 10mg
Outcomes
Primary Outcomes
Changes in HbA1c
Time Frame: 24th week
Changes in HbA1c at the 24th week after the administration of investigational products from the baseline