A Phase 3 interventional study of Luseogliflozin in Diabetes Mellitus Type 2, sponsored by Aimi Fadilah Mohamad. Completed at 1 site in Malaysia. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Aimi Fadilah Mohamad · Phase 3, Interventional, and Treatment
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.
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 40 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with Aimi Fadilah Mohamad as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Control group will not be taking any new medications other than their own standard medication for diabetes.
Intervention group will be taking Luseogliflozin 2.5mg daily for 12 weeks in addition to their own medications for their diabetes care.
Drug: Luseogliflozin
Luseogliflozin 2.5mg daily
Incidence of ketonemia
Ketonemia assessed with blood ketone (mmol/L) measurement. The mean (SD) of blood ketone for the 2 arms will be assessed. Percentage of patients with ketonemia in each arm to be evaluated.
Time frame: 12 weeks
Incidence of ketonuria
Ketonuria assessed with urine ketone (mmol/L) measurement. The mean (SD) of urine ketone for the 2 arms will be assessed. Percentage of patients with ketonuria in each arm to be evaluated.
Time frame: 12 weeks
Change in HOMA-IR levels
HOMA-IR is one of the measures of insulin resistance. Delta change in HOMA-IR levels pre- and post-intervention will be measured. The homeostatic model assessment for insulin resistance (HOMA-IR) was calculated with the following formula: \[fasting insulin (mmol/L) × fasting plasma glucose(mmol/L) /22.5\].
Time frame: 12 weeks
Change in triglyceride glucose index (TGI) levels
TGI is one of the measures of insulin resistance. Delta change of the TGI levels pre- and post-intervention will be measured. The triglyceride glucose index (TGI) was calculated with the formula: ln\[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL)/2\].
Time frame: 12 weeks
Change in HbA1c level
HbA1c is a blood test for assessing glycaemic control. Measurement of HbA1c (%) will be performed and delta change pre-and post-intervention will be measured.
Time frame: 12 weeks
Change in Body Mass Index (BMI)
The Body Mass Index (BMI) formula is ({weight (kg)} / \[{height (m)}\]\^2). Change in BMI pre- and post-intervention will be measured.
Time frame: 12 weeks
Change in body weight
Body weight of patient will be measured in kg. Delta change in weight pre-and post intervention will be assessed.
Time frame: 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — IPD may be available on request once study has been published.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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