Diabete MellitusPhase 1NCT07367555
Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients
A Phase 1 study testing Oral 100 gram Empagliflozin tablet along with diet plan and exercise and Diet plan and exercise in people with Diabete Mellitus, run by Ariba Shafiq at 1 site in Pakistan.
Trial summary
Total of 360 participants were enrolled and prescribed oral 200 mg SGLT-2 tablet. All participants were followed-up for about three months. Body mass index was measured before and after three months and mean change in BMI was assessed. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- Oral 100 gram Empagliflozin tablet along with diet plan and exercise and Diet plan and exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 31 Mar 2025
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with type II diabetes mellitus ( blood sugar level (random) at presentation was above 186 mg/dl and HbA1c was more than 6.5% on laboratory investigations)
Who cannot join
- Individuals already taking trail drug or any other anti-glycemic drug or insulin for >6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients"
Total of 360 participants were enrolled and prescribed oral 200 mg SGLT-2 tablet. All participants were followed-up for about three months. Body mass index was measured before and after three months and mean change in BMI was assessed.
- Conditions
- Diabete Mellitus
- Being tested
- Oral 100 gram Empagliflozin tablet along with diet plan and exercise, Diet plan and exercise
- Keywords
- Body Mass Index, Glycemic Index, Sodium Glucose Co-transporter-2 Inhibitors
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral 100 gram Empagliflozin tablet along with diet plan and exerciseDrug
oral 100 gram Empagliflozin tablet along with diet plan and exercise
Diet plan and exerciseOther
Only Life style modification was advised. Changes in BMI were assessed.
| Study group | Role | What they receive |
|---|---|---|
| Group A participants with Type II Diabetes Mellitus | Experimental | Randomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated. Receives: Drug: Oral 100 gram Empagliflozin tablet along with diet plan and exercise |
| Group B participants with Type II Diabetes Mellitus | Active comparator | Randomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated. Receives: Other: Diet plan and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight is measured in Kilograms
Measured: 03 Months
Secondary outcomes (1)
Height
Height is measured in meters
Measured: 03 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ariba Shafiq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ariba Shafiq, Combined Military Hospital Multan
- Investigators
- Professor Dr Khalid Mehmood Raja, MBBS FCPS, Study director, CMH Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367555
- Sponsor's protocol ID
- 14
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients"
- ClinicalTrials.gov ID
- NCT07367555
- Acronym / sponsor ID
- 14
- Conditions
- Diabete Mellitus
- Keywords
- Body Mass Index, Glycemic Index, Sodium Glucose Co-transporter-2 Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Ariba ShafiqUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 26 Jan 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.
Total of 360 participants were enrolled and prescribed oral 200 mg SGLT-2 tablet. All participants were followed-up for about three months. Body mass index was measured before and after three months and mean change in BMI was assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A participants with Type II Diabetes Mellitus | Experimental | Drug: Oral 100 gram Empagliflozin tablet along with diet plan and exerciseRandomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated. |
| Group B participants with Type II Diabetes Mellitus | Active comparator | Other: Diet plan and exerciseRandomly 180 Individuals with diagnosed type 2 Diabetes Mellitus were allocated group A. These individuals were prescribed oral 100 gram Empagliflozin tablet along with diet plan and exercise. All individuals were followed-up in OPD for 3 months. After 3 months, individuals were assessed again for height, weight, and BMI. Changes in weight and BMI were calculated. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with type II diabetes mellitus ( blood sugar level (random) at presentation was above 186 mg/dl and HbA1c was more than 6.5% on laboratory investigations)
Key exclusion criteria (1 listed)
- Individuals already taking trail drug or any other anti-glycemic drug or insulin for >6 months
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 |
|---|---|---|
| Oral 100 gram Empagliflozin tablet along with diet plan and exerciseoral 100 gram Empagliflozin tablet along with diet plan and exercise | Drug | Group A participants with Type II Diabetes Mellitus |
| Diet plan and exerciseOnly Life style modification was advised. Changes in BMI were assessed. | Other | Group B participants with Type II Diabetes Mellitus |
Primary outcome
Weight
Time frame: 03 Months
Weight is measured in Kilograms
1 secondary outcome
Height
Time frame: 03 months
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 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Professor Dr Khalid Mehmood Raja, MBBS FCPS study director
CMH Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral 100 gram Empagliflozin tablet along with diet plan and exercise and Diet plan and exercise in people with Diabete Mellitus, run by Ariba Shafiq at 1 site in Pakistan.
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 1 inclusion and 1 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 26 Jan 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 Pakistan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Weight (time frame: 03 Months). 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 26 Jan 2026.