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

NCT04885712 | Completed Phase 3

• 1 other identifier: BR-DPC-CT-301
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Changes in HbA1c

  Changes in HbA1c at the 24th week after the administration of investigational products from the baseline

  24th week

Study Arms (3)

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo

EXPERIMENTAL

Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo

Drug: Metformin≥1000mg; Drug: Pioglitazone 15mg; Drug: Pioglitazone 30mg Placebo; Drug: Dapagliflozin 10mg

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo

EXPERIMENTAL

Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo

Drug: Metformin≥1000mg; Drug: Pioglitazone 30 mg; Drug: Pioglitazone 15mg Placebo; Drug: Dapagliflozin 10mg

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo

ACTIVE COMPARATOR

Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo

Drug: Metformin≥1000mg; Drug: Pioglitazone 15mg Placebo; Drug: Pioglitazone 30mg Placebo; Drug: Dapagliflozin 10mg

Interventions

Metformin≥1000mg DRUG

Subjects take the investigational products once a day for 24 weeks.

Also known as: BR3003D

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo; Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo; Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo

Pioglitazone 15mg DRUG

Subjects take the investigational products once a day for 24 weeks.

Also known as: BR3003A-1

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo

Pioglitazone 30 mg DRUG

Subjects take the investigational products once a day for 24 weeks.

Also known as: BR3003B-1

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo

Pioglitazone 15mg Placebo DRUG

Subjects take the investigational products once a day for 24 weeks.

Also known as: BR3003A-2

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo; Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo

Pioglitazone 30mg Placebo DRUG

Subjects take the investigational products once a day for 24 weeks.

Also known as: BR3003B-2

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo; Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo

Dapagliflozin 10mg DRUG

Subjects take the investigational products once a day for 24 weeks.

Also known as: BR3003C

Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg Placebo; Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg Placebo; Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Cho YK, Kim KS, Lee BW, Hong JH, Yu JM, Lim S, Kim YA, Lee CB, Kim SS, Kwak SH, Lee WJ. Efficacy and Safety of Pioglitazone Add-on in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin and Dapagliflozin: A Multicenter, Randomized, Double-blind, and Placebo-controlled Study. Clin Ther. 2024 Sep;46(9):662-669. doi: 10.1016/j.clinthera.2024.06.023. Epub 2024 Jul 26.

  PMID: 39068060 DERIVED

MeSH Terms

Interventions

Pioglitazone; dapagliflozin

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Woo-je Lee

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 13, 2021
• Study Start: May 28, 2021
• Primary Completion: September 19, 2022
• Study Completion: March 10, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

KR (1)