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Type2 DiabetesPhase 3NCT04885712

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

A Phase 3 study testing Metformin≥1000mg, Pioglitazone 15mg and Pioglitazone 30 mg in people with Type2 Diabetes, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Type2 Diabetes
What is being tested?
Metformin≥1000mg, Pioglitazone 15mg and Pioglitazone 30 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
378 participants
Where
1 siteSouth Korea
Study dates
28 May 2021to 10 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: 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

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
Being tested
Metformin≥1000mg, Pioglitazone 15mg, Pioglitazone 30 mg, Pioglitazone 15mg Placebo, Pioglitazone 30mg Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin≥1000mgDrug

    Also called BR3003D

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

  • Pioglitazone 15mgDrug

    Also called BR3003A-1

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

  • Pioglitazone 30 mgDrug

    Also called BR3003B-1

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

  • Pioglitazone 15mg PlaceboDrug

    Also called BR3003A-2

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

  • Pioglitazone 30mg PlaceboDrug

    Also called BR3003B-2

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

  • Dapagliflozin 10mgDrug

    Also called BR3003C

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

Study groups in NCT04885712
Study groupRoleWhat they receive
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg + Pioglitazone 30mg PlaceboExperimentalMetformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo
Receives: Drug: Metformin≥1000mg; Drug: Pioglitazone 15mg; Drug: Pioglitazone 30mg Placebo; Drug: Dapagliflozin 10mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 30mg +Pioglitazone 15mg PlaceboExperimentalMetformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo
Receives: Drug: Metformin≥1000mg; Drug: Pioglitazone 30 mg; Drug: Pioglitazone 15mg Placebo; Drug: Dapagliflozin 10mg
Metformin≥1000mg + Dapagliflozin 10mg + Pioglitazone 15mg Placebo+ Pioglitazone 30mg PlaceboActive comparatorMetformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo
Receives: Drug: Metformin≥1000mg; Drug: Pioglitazone 15mg Placebo; Drug: Pioglitazone 30mg Placebo; Drug: Dapagliflozin 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in HbA1c

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

    Measured: 24th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start28 May 2021
  3. Primary completion19 Sep 2022
  4. Study completion10 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885712
Sponsor's protocol ID
BR-DPC-CT-301
Status last verified
May 2023
First submitted
9 May 2021
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39068060

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin≥1000mg, Pioglitazone 15mg and Pioglitazone 30 mg in people with Type2 Diabetes, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in HbA1c (time frame: 24th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885712, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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