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Clinical Trial NCT07367555 for Diabete Mellitus is completed. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients Phase 1 360
Clinical Trial NCT07367555 was designed to study Treatment for Diabete Mellitus. This was a Phase 1 interventional study that is now completed. The study started on 1 October 2024, with plans to enroll 360 participants. Led by Ariba Shafiq, the expected completion date was 31 March 2025. The latest data from ClinicalTrials.gov was last updated on 26 January 2026.
Brief 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.
Official Title
Effect Of Sodium Glucose Co-Transporter-2 (SGLT-2) Inhibitors on Body Mass Index After 3 Months of Use in Diabetic Patients"
Conditions
Diabete MellitusOther Study IDs
- 14
NCT ID Number
Start Date (Actual)
2024-10-01
Last Update Posted
2026-01-26
Completion Date (Estimated)
2025-03-31
Enrollment (Estimated)
360
Study Type
Interventional
PHASE
Phase 1
Status
Completed
Keywords
Body Mass Index
Glycemic Index
Sodium Glucose Co-transporter-2 Inhibitors
Glycemic Index
Sodium Glucose Co-transporter-2 Inhibitors
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGroup A participants with Type II Diabetes Mellitus 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. | Oral 100 gram Empagliflozin tablet along with diet plan and exercise oral 100 gram Empagliflozin tablet along with diet plan and exercise |
Active ComparatorGroup B participants with Type II Diabetes Mellitus 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. | Diet plan and exercise Only Life style modification was advised. Changes in BMI were assessed. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Weight | Weight is measured in Kilograms | 03 Months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Height | Height is measured in meters | 03 months |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
30 Years
Eligible Sexes
All
- 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)
- Individuals already taking trail drug or any other anti-glycemic drug or insulin for >6 months
Ariba ShafiqStudy Responsible Party
Ariba Shafiq, Sponsor-Investigator, Principal Investigator, Combined Military Hospital Multan
No contact data.
1 Study Locations in 1 Countries
Punjab Province
CMH Multan, Multan, Punjab Province, 60010, Pakistan