Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
NCT ID: NCT04665284
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
244 participants
INTERVENTIONAL
2019-06-01
2020-09-28
Brief Summary
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Detailed Description
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A number of oral agents targeting various sites of action are available. Sodium-glucose cotransporter-2 (SGLT2) inhibitors are newer class of drugs that have been introduced. They have a unique mechanism of action. By acting at the sodium glucose co-transporter, they block the reabsorption of glucose leading to an increase in urinary glucose excretion and lowering of plasma glucose.5 This action is completely independent of the beta cell function. There are several theoretical advantages to this approach. In addition to lowering blood glucose, the urinary glucose excretion results in loss of calories and weight reduction and the associated osmotic diuretic effect can aid in lowering blood pressures.6,7 Numerous studies have demonstrated a favorable risk benefit ratio of empagliflozin as monotherapy8 as well as add-on therapy to other hypoglycemic agents.9,10,11,12 They also have additional cardiovascular benefits with several studies documenting a reduction in mortality.13,14 Moreover, the sodium glucose co-transporters also demonstrated a reduction in the onset and worsening of nephropathy and preservation of renal function.15 This effect is not restricted to empagliflozin alone, as other drugs in the class have also demonstrated this benefit.16 Empagliflozin with its novel mechanism of action has its own set of side effects. Increased urinary glucose losses lead to a higher proportion of urinary tract infections and genital tract infections. This has been evidenced in various studies.17 The osmotic diuresis that benefits in lowering blood pressures at one end, also predisposes the patients to volume depletion.Empagliflozin, one of the three drugs from this class, approved by the FDA for treatment of type 2 diabetes. According to the recent ADA and the EASD guidelines, they have become an essential component of the algorithm recommended for managing type 2 diabetes.18 The recently published consensus statement by the South Asian Federation of Endocrine Societies has incorporated sodium glucose co-transporter 2 inhibitors in the treatment of patients with type 2 diabetes as monotherapy in patients who are intolerant to or have any contraindication to metformin therapy. Additionally, drugs belonging to this class are also recommended as combination therapy with other oral hypoglycemic agents as well as insulin.19 Empagliflozin, however, has not been studied in the Pakistani population as yet. The main aim of this study is to establish the efficacy and safety of empagliflozin in optimum control of blood sugar in type 2 diabetes. This is the first study of its kind being performed in the Pakistani population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Empagliflozin
Empagliflozin
Group A: Empagliflozin 10/25 mg once daily with or without antidiabetic drugs
Usual Care Group
Usual care group
Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
Interventions
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Empagliflozin
Group A: Empagliflozin 10/25 mg once daily with or without antidiabetic drugs
Usual care group
Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient who give informed consent voluntarily
* BMI ≤45 kg/m2
* Glycosylated hemoglobin of 7 - ≤10%
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Getz Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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A H Aamir
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Medical Institute
Locations
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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
Countries
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References
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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.
Other Identifiers
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GTZ-DM-001-19
Identifier Type: -
Identifier Source: org_study_id