Diabetes Mellitus Type 2Phase 3LUSIRESNCT07876258
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.
A Phase 3 study testing Luseogliflozin in people with Diabetes Mellitus Type 2, run by Aimi Fadilah Mohamad at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Luseogliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 May 2022to 30 Nov 2024
- Phase
- Phase 3
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Type 1 diabetes mellitus
- Frequent hypoglycemia
- Recent hospital admission within the past 3 months
- Persistent elevations of serum transaminase
- Active systemic inflammatory disease on immunosuppressant therapy
- Chronic heart failure (New York Heart Association functional class III-IV)
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- Chronic renal failure (egfr <50) and those requiring dialysis
- Active hepatic and collagen diseases, malignancy
- Pregnant, breastfeeding or planning to conceive within the next year -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Luseogliflozin on Risk of Ketoacidosis and Insulin Resistance in Type 2 Diabetes Mellitus Patients on Moderate Dose Insulin
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?
Read more
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.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Luseogliflozin
- 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.
LuseogliflozinDrug
Luseogliflozin 2.5mg daily
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group will not be taking any new medications other than their own standard medication for diabetes. |
| Intervention | Active comparator | Intervention group will be taking Luseogliflozin 2.5mg daily for 12 weeks in addition to their own medications for their diabetes care. Receives: Drug: Luseogliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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].
Measured: 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].
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 May 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aimi Fadilah Mohamad
- Sponsor type
- University, hospital or other
- Collaborators
- Taisho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Aimi Fadilah Mohamad, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876258
- Sponsor's protocol ID
- 600-TNCPI(5/1/6)
- Acronym
- LUSIRES
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be available on request once study has been published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Luseogliflozin on Risk of Ketoacidosis and Insulin Resistance in Type 2 Diabetes Mellitus Patients on Moderate Dose Insulin
- ClinicalTrials.gov ID
- NCT07876258
- Acronym / sponsor ID
- LUSIRES / 600-TNCPI(5/1/6)
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aimi Fadilah MohamadUniversity, hospital or other
- Collaborators
- Taisho Pharmaceutical Co., Ltd.
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 15 Oct 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group will not be taking any new medications other than their own standard medication for diabetes. |
| Intervention | Active comparator | Drug: LuseogliflozinIntervention group will be taking Luseogliflozin 2.5mg daily for 12 weeks in addition to their own medications for their diabetes care. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Type 1 diabetes mellitus
- Frequent hypoglycemia
- Recent hospital admission within the past 3 months
- Persistent elevations of serum transaminase
- Active systemic inflammatory disease on immunosuppressant therapy
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 |
|---|---|---|
| LuseogliflozinLuseogliflozin 2.5mg daily | Drug | Intervention |
Primary outcome
Incidence of ketonemia
Time frame: 12 weeks
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.
Incidence of ketonuria
Time frame: 12 weeks
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.
Change in HOMA-IR levels
Time frame: 12 weeks
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].
Change in triglyceride glucose index (TGI) levels
Time frame: 12 weeks
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].
3 secondary outcomes
Change in HbA1c level
Time frame: 12 weeks
Change in Body Mass Index (BMI)
Time frame: 12 weeks
Change in body weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided. IPD may be available on request once study has been published.
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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.
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 3 study testing Luseogliflozin in people with Diabetes Mellitus Type 2, run by Aimi Fadilah Mohamad at 1 site in Malaysia.
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 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: finished, as of the sponsor's last update on 15 Oct 2026. 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 Malaysia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of ketonemia (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 15 Oct 2026.