Diabetes Type 2Phase 4Location-FNCT05915949
Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety
A Phase 4 study testing Dapagliflozin 10mg Tab, Lobeglitazone 0.5 mg and Dapagliflozin + Lobeglitazone in people with Diabetes Type 2, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Diabetes is the most frequently occurring chronic disease along with obesity, hypertension, and hyperlipidemia. The number of patients with diabetes is increasing worldwide. Despite rapid progress in management of diabetes, the problem is that glycemic target goal is still low showing 30-40%. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Dapagliflozin 10mg Tab, Lobeglitazone 0.5 mg and Dapagliflozin + Lobeglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetic patients between the ages of 20 and 80 who are taking oral diabetes medications (metformin and/or DPP-4 inhibitors) for more than 8 weeks without dose adjustment
- body mass index (BMI) ≥ 20 kg/m2
- eGFR ≥ 50 mL/min/1.73 m2
- HbA1c: 7-10%.
Who cannot join
- patients with type 1 diabetes; HbA1c <7% or HbA1c >10%
- fasting blood glucose (FPG) >15 mmol/L (270 mg/dL) at the first visit (screening) and pre-randomization screening
- women of childbearing potential (if not using proper contraception)
- history of gastric surgery (including gastric banding within 3 years)
- history of diabetic ketoacidosis or non-ketogenic hyperosmotic coma
- average of 3 blood pressure measurements is systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg
Show all 9Show fewer
- heart failure NYHA class III or IV
- AST or ALT greater than 3 times the upper limit of normal
- systemic corticosteroids have been used for 10 consecutive days within 90 days (topical, eye drop, topical or inhalation agents)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Soo Lim, MD, PHD, 82-31-787-7035, limsoo@snu.ac.kr
Soo Lim, MD, PHD
About this study
Official title: Evaluation of the Efficacy of Combination of Dapagliflozin and Lobeglitazone on Glucose Concentrations and Body Fat in Patients With Type 2 Diabetes
Diabetes is the most frequently occurring chronic disease along with obesity, hypertension, and hyperlipidemia. The number of patients with diabetes is increasing worldwide. Despite rapid progress in management of diabetes, the problem is that glycemic target goal is still low showing 30-40%. Thus, diabetes has become a serious social, economic, and public health problem beyond individual health problems due to its increasing prevalence.
Read the detailed description
Previously, metformin, sulfonylurea, and insulin injections were used to treat diabetes, but since then, various new drugs such as thiazolidinedione (TZD), sodium-glucose cotransporter-2 (SGLT-2) inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor, and glucagon like peptide-1 (GLP-1) receptor agonist have been released. Among them, metformin and TZD are known to improve insulin resistance, SGLT-2 inhibitor has a mechanism to excrete glucose into urine, and other drugs have a mechanism to promote insulin secretion.
After a report in 2007 that rosiglitazone could increase cardiovascular disease, use of TZD has been limited. However, more people are having insulin resistance, and this is more evident in developing countries. In this circumstance, TZD can be a main stay for diabetic patients with insulin resistance. TZDs improve insulin sensitivity by activating peroxisome proliferator-activated receptor γ (PPARγ). They have shown excellent glycemic durability. On the other hand, SGLT-2 inhibitors are attracting attention as a mechanism that directly excretes excess glucose in diabetic patients through urine. Many cardiovascular outcome trials have proven its efficacy in cardiovascular and renal outcomes. Current guidelines proposed a new paradigm in the management of T2DM, with a preferential place for SGLT-2 inhibitors, after metformin, in patients with atherosclerotic cardiovascular disease, heart failure and progressive kidney disease.
As such, combination therapy of TZD and SGLT-2 inhibitors, two drugs that have mechanisms for improving insulin resistance and urinary glucose excretion, would have compensatory effects, which would be effective for diabetes treatment. In addition, since studies that investigated effect of TZD and SGLT-2 inhibitor combination on changes in body fat mass and metabolic phenotype are lacking, we investigated the effect of reducing visceral fat (abdominal visceral fat mass/abdominal subcutaneous fat mass) in combination therapy with dapagliflozin, an SGLT-2 inhibitor, and lobeglitazone, a TZD.
- Conditions
- Diabetes Type 2
- Being tested
- Dapagliflozin 10mg Tab, Lobeglitazone 0.5 mg, Dapagliflozin + Lobeglitazone
- Keywords
- diabetes type 2
- 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.
Dapagliflozin 10mg TabDrug
Also called Forxiga 10mg
Forxiga 10mg Tab once daily will be given to participants for 24 weeks.
Lobeglitazone 0.5 mgDrug
Also called Duvie 0.5 mg
Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.
Dapagliflozin + LobeglitazoneDrug
Also called Forxiga 10mg + Duvie 0.5mg
Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10 mg once daily will be given to participants. Receives: Drug: Dapagliflozin 10mg Tab |
| Lobeglitazone | Active comparator | Lobeglitazone 0.5 mg once daily will be given to participants. Receives: Drug: Lobeglitazone 0.5 mg |
| Dapagliflozin and Lobeglitazone combined | Active comparator | Dapagliflozin 10 mg and lobeglitazone 0.5 mg once daily together will be given to participants. Receives: Drug: Dapagliflozin + Lobeglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Glycemic control
Measured: 6 months
Secondary outcomes (12)
Fasting plasma glucose
Glucose metabolism
Measured: 6 months
Postprandial glucose
Glucose metabolism
Measured: 6 months
Whole body muscle
Body composition
Measured: 6 months
Whole body fat
Body composition
Measured: 6 months
Abdominal subcutaneous fat
Body composition
Measured: 6 months
Abdominal visceral fat
Body composition
Measured: 6 months
NTproBNP
Cardiac marker
Measured: 6 months
Troponin T
Cardiac marker
Measured: 6 months
Lipids
Lipid profiles (TG, HDL, and LDL)
Measured: 6 months
Lipoprotein (a)
Lipid metabolism
Measured: 6 months
Urinary microalbumin-Creatinine ratio
Lipid metabolism
Measured: 6 months
Fib-4
Hepatic fibrosis marker
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jan 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915949
- Sponsor's protocol ID
- B-1910-568-001
- Acronym
- Location-F
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Combination of Dapagliflozin and Lobeglitazone on Glucose Concentrations and Body Fat in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05915949
- Acronym / sponsor ID
- Location-F / B-1910-568-001
- Conditions
- Diabetes Type 2
- Keywords
- diabetes type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is the most frequently occurring chronic disease along with obesity, hypertension, and hyperlipidemia. The number of patients with diabetes is increasing worldwide. Despite rapid progress in management of diabetes, the problem is that glycemic target goal is still low showing 30-40%. Thus, diabetes has become a serious social, economic, and public health problem beyond individual health problems due to its increasing prevalence.
Detailed description
Previously, metformin, sulfonylurea, and insulin injections were used to treat diabetes, but since then, various new drugs such as thiazolidinedione (TZD), sodium-glucose cotransporter-2 (SGLT-2) inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor, and glucagon like peptide-1 (GLP-1) receptor agonist have been released. Among them, metformin and TZD are known to improve insulin resistance, SGLT-2 inhibitor has a mechanism to excrete glucose into urine, and other drugs have a mechanism to promote insulin secretion.
After a report in 2007 that rosiglitazone could increase cardiovascular disease, use of TZD has been limited. However, more people are having insulin resistance, and this is more evident in developing countries. In this circumstance, TZD can be a main stay for diabetic patients with insulin resistance. TZDs improve insulin sensitivity by activating peroxisome proliferator-activated receptor γ (PPARγ). They have shown excellent glycemic durability. On the other hand, SGLT-2 inhibitors are attracting attention as a mechanism that directly excretes excess glucose in diabetic patients through urine. Many cardiovascular outcome trials have proven its efficacy in cardiovascular and renal outcomes. Current guidelines proposed a new paradigm in the management of T2DM, with a preferential place for SGLT-2 inhibitors, after metformin, in patients with atherosclerotic cardiovascular disease, heart failure and progressive kidney disease.
As such, combination therapy of TZD and SGLT-2 inhibitors, two drugs that have mechanisms for improving insulin resistance and urinary glucose excretion, would have compensatory effects, which would be effective for diabetes treatment. In addition, since studies that investigated effect of TZD and SGLT-2 inhibitor combination on changes in body fat mass and metabolic phenotype are lacking, we investigated the effect of reducing visceral fat (abdominal visceral fat mass/abdominal subcutaneous fat mass) in combination therapy with dapagliflozin, an SGLT-2 inhibitor, and lobeglitazone, a TZD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg TabDapagliflozin 10 mg once daily will be given to participants. |
| Lobeglitazone | Active comparator | Drug: Lobeglitazone 0.5 mgLobeglitazone 0.5 mg once daily will be given to participants. |
| Dapagliflozin and Lobeglitazone combined | Active comparator | Drug: Dapagliflozin + LobeglitazoneDapagliflozin 10 mg and lobeglitazone 0.5 mg once daily together will be given to participants. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetic patients between the ages of 20 and 80 who are taking oral diabetes medications (metformin and/or DPP-4 inhibitors) for more than 8 weeks without dose adjustment
- body mass index (BMI) ≥ 20 kg/m2
- eGFR ≥ 50 mL/min/1.73 m2
- HbA1c: 7-10%.
Key exclusion criteria (9 listed)
- patients with type 1 diabetes; HbA1c <7% or HbA1c >10%
- fasting blood glucose (FPG) >15 mmol/L (270 mg/dL) at the first visit (screening) and pre-randomization screening
- women of childbearing potential (if not using proper contraception)
- history of gastric surgery (including gastric banding within 3 years)
- history of diabetic ketoacidosis or non-ketogenic hyperosmotic coma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10mg TabAlso: Forxiga 10mgForxiga 10mg Tab once daily will be given to participants for 24 weeks. | Drug | Dapagliflozin |
| Lobeglitazone 0.5 mgAlso: Duvie 0.5 mgDuvie 0.5mg Tab once daily will be given to participants for 24 weeks. | Drug | Lobeglitazone |
| Dapagliflozin + LobeglitazoneAlso: Forxiga 10mg + Duvie 0.5mgDuvie 0.5mg Tab once daily will be given to participants for 24 weeks. | Drug | Dapagliflozin and Lobeglitazone combined |
Primary outcome
HbA1c
Time frame: 6 months
Glycemic control
12 secondary outcomes
Fasting plasma glucose
Time frame: 6 months
Postprandial glucose
Time frame: 6 months
Whole body muscle
Time frame: 6 months
Whole body fat
Time frame: 6 months
Abdominal subcutaneous fat
Time frame: 6 months
Abdominal visceral fat
Time frame: 6 months
NTproBNP
Time frame: 6 months
Troponin T
Time frame: 6 months
Lipids
Time frame: 6 months
Lipoprotein (a)
Time frame: 6 months
Urinary microalbumin-Creatinine ratio
Time frame: 6 months
Fib-4
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10mg Tab, Lobeglitazone 0.5 mg and Dapagliflozin + Lobeglitazone in people with Diabetes Type 2, run by Seoul National University Bundang Hospital 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minji Sohn, PhD (82-031-787-7041, 65423@snuhb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.