Diabetes Mellitus, Type 2Phase 4NCT07108985
Effect of Add-on SGLT2i, TZD, or Combination Therapy in Type 2 Diabetes Patients on DPP4 Inhibitors
A Phase 4 study testing Sitagliptin 100 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg and Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Yonsei University at 1 site in South Korea.
Trial summary
This clinical trial investigates the effects of adding different diabetes medications to patients with type 2 diabetes who are currently being treated with DPP4 inhibitors. The study evaluates three treatment strategies: SGLT2 inhibitor monotherapy, TZD monotherapy, and a combination of both SGLT2 inhibitor and TZD. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperglycemia, Insulin Resistance
- What is being tested?
- Sitagliptin 100 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg and Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2025to 31 Aug 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 19 and 75 years at the time of providing written informed consent.
- Diagnosed with type 2 diabetes mellitus and having an HbA1c level between 7.5% and 11.0%.
- Receiving DPP4 inhibitor monotherapy or combination therapy with metformin and/or sulfonylurea for at least 8 weeks without dose adjustment.
- Provided written informed consent voluntarily after receiving a full explanation of the study.
- Considered capable of understanding the study procedures and cooperating throughout the study period until completion.
Who cannot join
- Patients with diabetes other than type 2 diabetes, including type 1 diabetes or gestational diabetes.
- Use of TZD or SGLT2 inhibitors within the past 8 weeks, or history of discontinuation due to serious adverse reactions.
- Currently receiving four or more antidiabetic medications.
- History of diabetic ketoacidosis (with or without coma) or acute/chronic metabolic acidosis within the past 24 weeks.
- Known allergy or hypersensitivity to the investigational drugs or their components.
- Chronic use (more than 14 consecutive days) of oral or parenteral corticosteroids within 8 weeks prior to screening, with ongoing need for dose adjustment.
Show all 19Show fewer
- Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Active or progressive malignant tumors requiring treatment.
- History of drug abuse or alcohol dependence within the past 12 weeks.
- HIV infection.
- Severe infections, perioperative status, or major trauma.
- History of heart failure classified as NYHA class III or IV within the past 24 weeks.
- History of acute cardiovascular events within the past 12 weeks (e.g., unstable angina, myocardial infarction, transient ischemic attack, stroke, coronary artery bypass grafting, or coronary intervention).
- Renal failure or chronic kidney disease with eGFR < 25 mL/min/1.73m² or undergoing dialysis.
- Active bladder cancer or history of bladder cancer.
- Abnormal liver function defined as serum ALT, AST, or alkaline phosphatase > 5× ULN, or total bilirubin > 5× ULN.
- Pregnant or breastfeeding women.
- Participation in another clinical trial or administration of investigational drugs within the past 12 weeks (except for observational or retrospective studies deemed not to affect the safety or efficacy of this trial).
- Determined by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Republic of Korea
Seoul, 03722
About this study
Official title: Prospective, Open-label, Randomized, Parallel-group, Multicenter, Investigator, Initiated Phase 4 Clinical Trial to Evaluate the Glycemic Lowering Effects of Adding SGLT2 Inhibitor Monotherapy, TZD Monotherapy, or SGLT2 Inhibitor/TZD Combination Therapy in Patients With Type 2 Diabetes on DPP4 Inhibitors
This clinical trial investigates the effects of adding different diabetes medications to patients with type 2 diabetes who are currently being treated with DPP4 inhibitors. The study evaluates three treatment strategies: SGLT2 inhibitor monotherapy, TZD monotherapy, and a combination of both SGLT2 inhibitor and TZD. Participants will be randomly assigned to one of four groups, including a control group continuing DPP4 inhibitor alone.
The primary objective is to assess changes in blood sugar control, specifically HbA1c levels, after 12 and 24 weeks of treatment. Secondary outcomes include changes in fasting and postprandial glucose, insulin, C-peptide, lipid profiles (total cholesterol, triglycerides, HDL-C, LDL-C), body composition (muscle mass, visceral fat, subcutaneous fat), and insulin resistance indicators such as HOMA-IR, HOMA-beta, and Insulinogenic Index.
Read more
Eligible participants are adults aged 19 to 75 years with type 2 diabetes who have been on stable doses of DPP4 inhibitors, with or without metformin or sulfonylurea, for at least 8 weeks. Individuals with recent use of SGLT2 inhibitors or TZDs, significant organ dysfunction, or other exclusion criteria will not be enrolled.
The study is open-label and multicenter, conducted at four hospitals in Korea. All medications used in the trial are provided by the sponsor. Participants will receive lifestyle counseling throughout the study period, including guidance on diet and exercise. Safety monitoring will be conducted regularly, and adverse events will be documented and managed according to protocol.
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia, Insulin Resistance
- Being tested
- Sitagliptin 100 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin 100 mgDrug
Sitagliptin 100 mg, taken once daily for 24 weeks.
Sitagliptin 100 mg + Dapagliflozin 10 mgDrug
Sitagliptin 100 mg + Dapagliflozin 10 mg, taken once daily for 24 weeks.
Sitagliptin 100 mg + Dapagliflozin 10 mgDrug
Sitagliptin 100 mg + Dapagliflozin 10 mg, taken once daily for 24 weeks.
Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mgDrug
Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg, taken once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sitagliptin 100 mg Receives: Drug: Sitagliptin 100 mg |
| B | Experimental | Sitagliptin 100 mg + Dapagliflozin 10 mg Receives: Drug: Sitagliptin 100 mg + Dapagliflozin 10 mg |
| C | Experimental | Sitagliptin 100 mg + Lobeglitazone 0.5 mg Receives: Drug: Sitagliptin 100 mg + Dapagliflozin 10 mg |
| D | Experimental | Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg Receives: Drug: Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c levels
To assess the change in HbA1c levels at 12 and 24 weeks after administration of the investigational drugs, by comparing pre- and post-treatment values within each group and between groups.
Measured: At 12 and 24 weeks after initiation of the investigational drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study startSep 2025 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108985
- Sponsor's protocol ID
- 4-2025-0720
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Randomized, Parallel-group, Multicenter, Investigator, Initiated Phase 4 Clinical Trial to Evaluate the Glycemic Lowering Effects of Adding SGLT2 Inhibitor Monotherapy, TZD Monotherapy, or SGLT2 Inhibitor/TZD Combination Therapy in Patients With Type 2 Diabetes on DPP4 Inhibitors
- ClinicalTrials.gov ID
- NCT07108985
- Acronym / sponsor ID
- 4-2025-0720
- Conditions
- Diabetes Mellitus, Type 2, Hyperglycemia, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 7 Aug 2025 (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.
This clinical trial investigates the effects of adding different diabetes medications to patients with type 2 diabetes who are currently being treated with DPP4 inhibitors. The study evaluates three treatment strategies: SGLT2 inhibitor monotherapy, TZD monotherapy, and a combination of both SGLT2 inhibitor and TZD. Participants will be randomly assigned to one of four groups, including a control group continuing DPP4 inhibitor alone.
The primary objective is to assess changes in blood sugar control, specifically HbA1c levels, after 12 and 24 weeks of treatment. Secondary outcomes include changes in fasting and postprandial glucose, insulin, C-peptide, lipid profiles (total cholesterol, triglycerides, HDL-C, LDL-C), body composition (muscle mass, visceral fat, subcutaneous fat), and insulin resistance indicators such as HOMA-IR, HOMA-beta, and Insulinogenic Index.
Eligible participants are adults aged 19 to 75 years with type 2 diabetes who have been on stable doses of DPP4 inhibitors, with or without metformin or sulfonylurea, for at least 8 weeks. Individuals with recent use of SGLT2 inhibitors or TZDs, significant organ dysfunction, or other exclusion criteria will not be enrolled.
The study is open-label and multicenter, conducted at four hospitals in Korea. All medications used in the trial are provided by the sponsor. Participants will receive lifestyle counseling throughout the study period, including guidance on diet and exercise. Safety monitoring will be conducted regularly, and adverse events will be documented and managed according to protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Sitagliptin 100 mgSitagliptin 100 mg |
| B | Experimental | Drug: Sitagliptin 100 mg + Dapagliflozin 10 mgSitagliptin 100 mg + Dapagliflozin 10 mg |
| C | Experimental | Drug: Sitagliptin 100 mg + Dapagliflozin 10 mgSitagliptin 100 mg + Lobeglitazone 0.5 mg |
| D | Experimental | Drug: Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mgSitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged between 19 and 75 years at the time of providing written informed consent.
- Diagnosed with type 2 diabetes mellitus and having an HbA1c level between 7.5% and 11.0%.
- Receiving DPP4 inhibitor monotherapy or combination therapy with metformin and/or sulfonylurea for at least 8 weeks without dose adjustment.
- Provided written informed consent voluntarily after receiving a full explanation of the study.
- Considered capable of understanding the study procedures and cooperating throughout the study period until completion.
Key exclusion criteria (19 listed)
- Patients with diabetes other than type 2 diabetes, including type 1 diabetes or gestational diabetes.
- Use of TZD or SGLT2 inhibitors within the past 8 weeks, or history of discontinuation due to serious adverse reactions.
- Currently receiving four or more antidiabetic medications.
- History of diabetic ketoacidosis (with or without coma) or acute/chronic metabolic acidosis within the past 24 weeks.
- Known allergy or hypersensitivity to the investigational drugs or their components.
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 |
|---|---|---|
| Sitagliptin 100 mgSitagliptin 100 mg, taken once daily for 24 weeks. | Drug | A |
| Sitagliptin 100 mg + Dapagliflozin 10 mgSitagliptin 100 mg + Dapagliflozin 10 mg, taken once daily for 24 weeks. | Drug | B |
| Sitagliptin 100 mg + Dapagliflozin 10 mgSitagliptin 100 mg + Dapagliflozin 10 mg, taken once daily for 24 weeks. | Drug | C |
| Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mgSitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg, taken once daily for 24 weeks. | Drug | D |
Primary outcome
change in HbA1c levels
Time frame: At 12 and 24 weeks after initiation of the investigational drug
To assess the change in HbA1c levels at 12 and 24 weeks after administration of the investigational drugs, by comparing pre- and post-treatment values within each group and between groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sitagliptin 100 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg and Sitagliptin 100 mg + Dapagliflozin 10 mg + Lobeglitazone 0.5 mg in people with Diabetes Mellitus, Type 2 and Hyperglycemia, 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 5 inclusion and 19 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: opening soon, as of the sponsor's last update on 7 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 in HbA1c levels (time frame: At 12 and 24 weeks after initiation of the investigational drug). 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 7 Aug 2025.