Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
SAFE-PAK
1 other identifier
interventional
244
1 country
11
Brief Summary
To compare the safety and efficacy of empagliflozin versus other treatments in Pakistani Muslim population with type II diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2019
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2020
CompletedFirst Submitted
Initial submission to the registry
November 27, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedDecember 11, 2020
December 1, 2020
1.3 years
November 27, 2020
December 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Frequency of participants achieved HbA1c level <7%
24 weeks
Frequency of participants achieved FBS level within normal range
24 weeks
Other Outcomes (6)
Number of participants reduces weight during the therapy
24 weeks
Number of participants reduces BMI level as per WHO Asian classification during the therapy
24 weeks
Number of participants reduces Waist circumference during the therapy
24 weeks
- +3 more other outcomes
Study Arms (2)
Empagliflozin
EXPERIMENTALUsual Care Group
ACTIVE COMPARATORInterventions
Group A: Empagliflozin 10/25 mg once daily with or without antidiabetic drugs
Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
Eligibility Criteria
You may qualify if:
- Pakistani muslim male / female, type 2 diabetic patient having age from 18 years to 75 years
- Patient who give informed consent voluntarily
- BMI ≤45 kg/m2
- Glycosylated hemoglobin of 7 - ≤10%
You may not qualify if:
- Patients who are on empagliflozin treatment
- Indication of liver disease, defined by serum levels of either alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase above 3 times upper limit to normal
- Estimated glomerular filtration rate (eGFR) \<45 mL /min /1.73m2
- History of recurrent urinary tract infection (UTI) and/or past 3 months' history of UTI and its treatment
- Patients with positive urine culture for UTI at the time of screening
- Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state
- Patients with past 3 months' history of fungal infection and its treatment
- History of blood dyscrasias or any disorders causing haemolysis or unstable red blood cell
- History of benign prostate hyperplasia
- Any acute coronary syndrome, stroke and/or transient ischemic attack (TIA) in the previous 3 months
- Any contraindication for patients to Biguanides, Sulfonylureas, DPP-IV inhibitors, SGLT-2 Inhibitors
- Treatment with anti-obesity drugs or any other treatment leading to unstable body weight
- Patients with past 6 weeks treatment history with systemic steroids or thyroid hormones or any other uncontrolled endocrine disorder except T2DM
- Pre-menopausal women who are nursing or pregnant or are of childbearing potential and not practicing an acceptable method of birth control
- Any other clinical condition that would jeopardize patients safety while participating in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Getz Pharmalead
Study Sites (11)
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 Province, Pakistan
Shifa International Hospital
Islamabad, Punjab Province, Pakistan
Diabetes Institute of Pakistan
Lahore, Punjab Province, Pakistan
Jinnah Hospital
Lahore, Punjab Province, Pakistan
National Defence Center
Lahore, Punjab Province, Pakistan
Al-Khaliq Hospital
Multan Khurd, Punjab Province, Pakistan
Fatimiyah Hospital
Karachi, Sindh, Pakistan
National Institute of Cardiovascular Disease
Karachi, Sindh, Pakistan
Related Publications (1)
Aamir AH, Raja UY, Qureshi FM, Asghar A, Mahar SA, Ahmed I, Ghaffar T, Zafar J, Hasan MI, Riaz A, Raza SA, Khosa IA, Khan J, Baqar JB. Safety and efficacy of Empagliflozin in Pakistani Muslim patients with type 2 diabetes (SAFE-PAK); a randomized clinical trial. BMC Endocr Disord. 2022 Nov 28;22(1):295. doi: 10.1186/s12902-022-01213-1.
PMID: 36443769DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A H Aamir
Post Graduate Medical Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2020
First Posted
December 11, 2020
Study Start
June 1, 2019
Primary Completion
September 15, 2020
Study Completion
September 28, 2020
Last Updated
December 11, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share