NCT07876258CompletedPhase 3
A Study in Type 2 Diabetes Patients Who Are Taking Moderate Dose Insulin, Looking at the Effects of the Medication Luseogliflozin on Risk of Ketoacidosis and Insulin Resistance.
Effect of Luseogliflozin on Risk of Ketoacidosis and Insulin Resistance in Type 2 Diabetes Mellitus Patients on Moderate Dose Insulin
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn if the drug Luseogliflozin works to treat people with diabetes who are taking moderate dose insulin treatment. It will also learn about the safety of the drug Luseogliflozin. The main questions it aims to answer are: Does Luseogliflozin improve the sugar control of people with diabetes by lowering the insulin resistance numbers in each participants? What is the likelihood of participants developing of a known side effect of this type of medications which is ketoacidosis when taking Luseogliflozin? Researchers will compare Luseogliflozin use in one group to a similar group not taking similar medications to see if Luseogliflozin showed any difference in the above. Participants will: Either take Luseogliflzoin 2.5mg daily for 12 weeks or no change in medications. Keep a diary of blood glucose readings during the period of 12 weeks. Blood taking and measurements of blood pressure, weight and waist circumference will be performed at initial visit and again at 12 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 3 Oct 2026
- Start date
- May 2022
- Primary completion date
- Nov 2024
- Lead sponsor
- Aimi Fadilah Mohamad
- Diseases
- Type 2 diabetes
- NCT number
- NCT07876258
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 40
- From May 2022 to the primary completion date, Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes mellitus
- Active systemic inflammatory disease on immunosuppressant therapy
- Chronic heart failure (New York Heart Association functional class III-IV)
- Active hepatic and collagen diseases, malignancy
Lab values
- Persistent elevations of serum transaminase
- Chronic renal failure (egfr \<50) and those requiring dialysis
Other
- Frequent hypoglycemia
- Recent hospital admission within the past 3 months
- Pregnant, breastfeeding or planning to conceive within the next year -
Who the study is looking for
- Diagnosis of T2DM
- BMI \> 23kg/m2
- Receiving insulin therapy of \> 0.5U/kg/day (basal and/or prandial insulins), on stable dose for the last 12 weeks
- HbA1c between 6.5 - 10.5%
- Egfr \>50ml/min
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universiti Teknologi MARA Coordinator of this site? Confirm its status | Sungai Buloh | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.