| Trial ID: | L4708 |
| Source ID: | NCT04665284
|
| Associated Drug: |
Empagliflozin
|
| Title: |
Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
|
| Acronym: |
SAFE-PAK
|
| Status: |
COMPLETED
|
| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type II Diabetes Mellitus
|
| Interventions: |
DRUG: Empagliflozin|DRUG: Usual care group
|
| Outcome Measures: |
Primary: Number of participants reported adverse events, Number of participants reported adverse events such as Hypoglycemic events, Hypotension, Dehydration, Urinary tract infection, Diabetic Ketoacidosis, Fungal infection or any other, 24 weeks | Secondary: Frequency of participants achieved HbA1c level <7%, Frequency of participants achieved HbA1c level \<7%, 24 weeks|Frequency of participants achieved FBS level within normal range, Frequency of participants achieved FBS level within normal range, 24 weeks | Other: Number of participants reduces weight during the therapy, Number of participants reduces weight during the therapy or mean reduction in weight overtime, 24 weeks|Number of participants reduces BMI level as per WHO Asian classification during the therapy, Number of participants reduces BMI or mean reduction in BMI overtime, 24 weeks|Number of participants reduces Waist circumference during the therapy, Number of participants reduces Waist circumference or mean reduction in BMI overtime, 24 weeks|Number of participants changes systolic blood pressure and diastolic blood pressure during the therapy, Number of participants reduces systolic blood pressure and diastolic blood pressure or mean reduction in systolic blood pressure and diastolic blood pressure overtime, 24 weeks|Number of participants changes LDL level and HDL Level during the therapy, Number of participants reduces LDL level and HDL Level or mean reduction in LDL level and HDL Level overtime, 24 weeks|Mean score of diabetes mellitus quality of life, The instrument provides an overall scale score, as well as two subscale scores for 1) satisfaction with treatment, 2) adherence with Self Care Regimen. 15 Items are scored on a 5-point Likert scale and are of two general formats.One format asks about the frequency of negative impact of diabetes itself or of the diabetes treatment and provides response options from 1 (never) to 5 (all the time). The second format asks about satisfaction with treatment and quality of life and is scored from 1 (very satisfied) to 5 (very dissatisfied). Higher scores on DQOL items and subscales are, therefore, negatively valenced, indicating problem frequency or dissatisfaction., 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Getz Pharma
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
244
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2019-06-01
|
| Completion Date: |
2020-09-28
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| Results First Posted: |
|
| Last Update Posted: |
2020-12-11
|
| Locations: |
Balochistan Medical Center, Quetta, Balochistan, Pakistan|Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan|Post Graduate Medical Institute, Peshawar, Khyber Pakhtunkhwa, Pakistan|Hanif Medical Center, Islamabad, Punjab, Pakistan|Shifa International Hospital, Islamabad, Punjab, Pakistan|Diabetes Institute of Pakistan, Lahore, Punjab, Pakistan|Jinnah Hospital, Lahore, Punjab, Pakistan|National Defence Center, Lahore, Punjab, Pakistan|Al-Khaliq Hospital, Multān, Punjab, Pakistan|Fatimiyah Hospital, Karachi, Sindh, Pakistan|National Institute of Cardiovascular Disease, Karachi, Sindh, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT04665284
|
