Comparing Dapagliflozin and Lobeglitazone for Type 2 Diabetes Management
Evaluation of the Efficacy of Combination of Dapagliflozin and Lobeglitazone on Glucose Concentrations and Body Fat in Patients With Type 2 Diabetes
This study tests whether a new combination of two diabetes medications, Dapagliflozin and Lobeglitazone, can help people with Type 2 Diabetes manage their blood sugar better than using just one of the medications alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam, Gyeonggi) |
| Trial ID | NCT05915949 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Dapagliflozin, Lobeglitazone, and their combination in treating Type 2 Diabetes. It targets patients who have been on oral diabetes medications for at least 8 weeks and assesses their glycemic control and insulin sensitivity. The study aims to determine whether the combination therapy can provide better outcomes compared to monotherapy. Participants will be monitored for changes in blood glucose levels and overall health during the trial.
Who should consider this trial
Good fit: Ideal candidates are Type 2 diabetic patients aged 20 to 80 who have been on oral diabetes medications without dose adjustments for more than 8 weeks.
Not a fit: Patients with Type 1 diabetes or those with poorly controlled blood glucose levels (HbA1c <7% or >10%) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with Type 2 Diabetes, enhancing glycemic control and reducing complications.
How similar studies have performed: Previous studies have shown positive outcomes with similar combination therapies in managing Type 2 Diabetes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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%. Exclusion Criteria: * 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 * 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)
Where this trial is running
Seongnam, Gyeonggi
- Seoul National University Bundang Hospital — Seongnam, Gyeonggi, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Minji Sohn, PhD
- Email: 65423@snuhb.org
- Phone: 82-031-787-7041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.