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AzTrials

Type 2 Diabetes MellitusPhase 4NCT04013581

Quadruple Oral Combination Therapy for Type 2 Diabetes Mellitus : Glycemic Control by Thiazolidinedione (TZD) or Sodium Glucose Co-transporter 2 (SGLT-2) Inhibitor as an add-on Therapy in Type 2 Diabetes Mellitus After Failure of an Oral Triple Antidiabetic Regimen

A Phase 4 study testing TZD group and SGLT-2 group in people with Type 2 Diabetes Mellitus, run by Yonsei University 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

In the treatment of type 2 diabetes (T2D), the number of patients requiring combination therapy of oral antidiabetic agents (OADs) is more than 70%. Especially in Korea, the tendency to avoid insulin therapy is relatively higher than other countries, therefore, the need for combination therapy of OADs is quite high. Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
TZD group and SGLT-2 group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteSouth Korea
Study dates
5 Aug 2019to 28 May 2020
Phase
Phase 4
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 19 ≤ age ≤ 80, male or female
  • 2. Type 2 diabetes patients who have taken triple combination therapy of OADs as followed : Metformin (≥1000 mg/day), Sulfonylurea (Glimepiride ≥ 4 mg/day or Gliclazide ≥ 60 mg/day), DPP-4 inhibitor (Full dose) for over 12 weeks
  • 3. At screening, 7% < HbA1c ≤ 10%
  • 4. Patients who refused insulin therapy.
  • 5. Subjects who understood the contents of the clinical trial and are cooperative in the trial progress, and are considered to be able to participate until the end of the trial.
  • 6. Patients who have voluntarily agreed in writing to participate in the clinical trial after hearing the explanation of the trial.

Who cannot join

  • 1. Type 1 diabetes, gestational diabetes, and other types of diabetes than type 2 diabetes mellitus.
  • 2. Patients who have the history of allergy of hypersensitivity for the medication of the clinical trial.
  • 3. Patients who have the history of taking TZDs or SGLT-2 inhibitors within a year prior to screening visit, or have the history of discontinuation of them due to severe side effects.
  • 4. Patients who have the history of acute or chronic metabolic acidosis including diabetic ketoacidosis (with or without coma), or any kinds of ketosis within 12 weeks prior to screening visit.
  • 5. Patients who have genetic metabolic diseases, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • 6. Patients who have the history of taking steroids for more than 2 weeks, within 8 weeks prior to screening visit.
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  • 7. Patients who have the history of malignancy within 5 years prior to screening visit (In case of bladder cancer, subjects will be excluded regardless of the time of diagnosis)
  • 8. Patients who have the history of coronary artery bypass surgery or percutaneous coronary intervention, or suffered from heart failure (NYHA class III, IV)
  • 9. Patients who have the history of uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient ischemic attacks, and cerebral vascular disease within 24 weeks prior to the screening date.
  • 10. Patients of chronic renal failure, chronic kidney disease stage 3~5 (estimated glomerular filtration rate calculated vial CKD-EPI <60 mL/min/1.73m2) or on dialysis therapy.
  • 11. Elevated liver enzymes (AST, ALT, ALP ≥ 2.5*upper limit of normal (ULN) or Total bilirubin ≥ 2.5*ULN) or Child-Pugh class B or C (for the patients of liver cirrhosis)
  • 12. Subjects who are pregnant or lactating
  • 13. Perioperative patients, patients with severe infections or severe trauma
  • 14. Patients with unexamined gross hematuria
  • 15. Any other subjects who is determined to be ineligible for the clinical trials by researchers.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine

    Seoul

Other trials in South Korea

About this study

In the treatment of type 2 diabetes (T2D), the number of patients requiring combination therapy of oral antidiabetic agents (OADs) is more than 70%. Especially in Korea, the tendency to avoid insulin therapy is relatively higher than other countries, therefore, the need for combination therapy of OADs is quite high. However, according to the current guidelines, clinicians are recommended to prescribe three or fewer OADs as the combination therapy for T2D. Recently, various OADs have been developed, and it is expected that quadruple combination therapy of OADs would be quite effective to lower blood glucose levels. In the present study, the investigators designed the study to compare the efficacy and safety of quadruple combination therapy; thiazolidinedione (TZD) vs. SGLT-2 inhibitor as an add-on therapy to triple combination therapy (Metformin, Sulfonylurea, Dipeptidyl peptidase-4(DPP-4) inhibitors). Quadruple combination therapy group with the SGLT-2 inhibitor will be considered as active control group, because it have shown non-inferior glycemic efficacy to the conventional insulin conversion therapy in a previous clinical study. Patients who could not achieve the target blood glucose level (7% <HbA1c ≤ 10%) under the triple combination therapy (Metformin, Sulfonylurea, DPP-4 inhibitors) for more than 12 weeks will be enrolled in this prospective, open-label, randomized, parallel comparison, multicenter clinical trial. Subjects in each group (60 patients/group) will be treated with TZD-containing quadruple therapy or SGLT-2 inhibitor-containing quadruple therapy for 24 weeks. The investigators will evaluate the glycemic efficacy and safety of each group. Primary outcome is the 24 week-change of HbA1c from baseline levels.

Being tested
TZD group, SGLT-2 group
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • TZD groupDrug

    Also called Acpio

    Pioglitazone 15mg (Acpio®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM(type 2 diabetes mellitus) patients who had inadequate glycemic control (7% <HbA1c ≤ 10%) with triple therapy (metformin, DPP-4 inhibitors, sulfonylurea). At visit 3 (after 12 week-treatment), patients whose HbA1c level is more than 7.0% will be prescribed increased dosage of pioglitazone : from 15mg to 30mg

  • SGLT-2 groupDrug

    Also called Jardiance

    Empagliflozin 10mg (Jardiance®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM patients who had inadequate glycemic control (7% <HbA1c ≤ 10%) with triple therapy (metformin, DPP-4 inhibitors, sulfonylurea). At visit 3 (after 12 week-treatment), patients whose HbA1c level is more than 7.0% will be prescribed increased dosage of empagliflozin : from 10mg to 25mg

Study groups in NCT04013581
Study groupRoleWhat they receive
TZD groupExperimentalPioglitazone added to Metformin, DPP-4 inhibitors, Sulfonylurea
Receives: Drug: TZD group
SGLT-2 inhibitor groupActive comparatorEmpagliflozin added to Metformin, DPP-4 inhibitors, Sulfonylurea
Receives: Drug: SGLT-2 group

What is being measured

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

  1. Change of HbA1c

    Measured: 12 weeks

  2. Change of HbA1c

    Mean difference of HbA1c after 24 week-treatment

    Measured: 24 weeks

Secondary outcomes (12)

  1. glucose

    Percentage of patients who achieve target HbA1c (≤7% level)

    Measured: 12 weeks

  2. glucose

    Mean difference of fasting blood glucose after 24 week-treatment

    Measured: 24 weeks

  3. Adverse events

    Incidence of adverse events during treatment period

    Measured: 12 weeks

  4. Adverse events

    Incidence of adverse events during treatment period

    Measured: 24 weeks

  5. Change of kidney function

    Mean change of BUN and serum creatinine

    Measured: 12 weeks

  6. Change of kidney function

    Mean change of BUN and serum creatinine

    Measured: 24 weeks

  7. Change of liver enzymes

    Mean change of AST(Asparate aminotransferase)

    Measured: 12 weeks

  8. Change of liver enzymes

    Mean change of ALT(Alanine aminotransferase)

    Measured: 12 weeks

  9. Change of liver enzymes

    Mean change of Total bilirubin

    Measured: 12 weeks

  10. Change of liver enzymes

    Mean change of AST

    Measured: 24 weeks

  11. Change of liver enzymes

    Mean change of ALT

    Measured: 24 weeks

  12. Change of liver enzymes

    Mean change of Total bilirubin

    Measured: 24 weeks

Timeline

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

  1. First posted9 Jul 2019
  2. Study start5 Aug 2019
  3. Primary completion13 May 2020
  4. Study completion28 May 2020

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, open label, randomized, parallel, multicenter clinical trial
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04013581
Sponsor's protocol ID
4-2019-0393
Status last verified
May 2021
First submitted
2 Jul 2019
Last updated
4 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TZD group and SGLT-2 group in people with Type 2 Diabetes Mellitus, run by Yonsei University 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 15 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 4 May 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Change of HbA1c (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT04013581.

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 4 May 2021.

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