Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665284
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-11-27
Brief Title:
Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
Sponsor:
Getz Pharma
Organization:
Getz Pharma
Study Overview
Official Title:
Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFE-PAK
Brief Summary:
To compare the safety and efficacy of empagliflozin versus other treatments in Pakistani Muslim population with type II diabetes mellitus
Detailed Description:
Diabetes is the one of the most common non-communicable diseases affecting 425 million adults worldwide This figure is expected to rise to 629 million by the year 20451 90 of the diabetic population has type 2 diabetes 2 As of 2018 more than 500 million individuals are residing with type 2 diabetes mellitus globally 3 In Pakistan the situation is similarly alarming According to a recent survey 1698 of the Pakistani population has diabetes4 The primary target of therapy in diabetes mellitus is optimum blood glucose control In case of type 2 diabetes this is achieved by a combination of oral hypoglycemic agents and injectable drugs with insulin as a last resort
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 glucose5 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 pressures67 Numerous studies have demonstrated a favorable risk benefit ratio of empagliflozin as monotherapy8 as well as add-on therapy to other hypoglycemic agents9101112 They also have additional cardiovascular benefits with several studies documenting a reduction in mortality1314 Moreover the sodium glucose co-transporters also demonstrated a reduction in the onset and worsening of nephropathy and preservation of renal function15 This effect is not restricted to empagliflozin alone as other drugs in the class have also demonstrated this benefit16 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 studies17 The osmotic diuresis that benefits in lowering blood pressures at one end also predisposes the patients to volume depletionEmpagliflozin 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 diabetes18 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 insulin19 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
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 glucose5 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 pressures67 Numerous studies have demonstrated a favorable risk benefit ratio of empagliflozin as monotherapy8 as well as add-on therapy to other hypoglycemic agents9101112 They also have additional cardiovascular benefits with several studies documenting a reduction in mortality1314 Moreover the sodium glucose co-transporters also demonstrated a reduction in the onset and worsening of nephropathy and preservation of renal function15 This effect is not restricted to empagliflozin alone as other drugs in the class have also demonstrated this benefit16 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 studies17 The osmotic diuresis that benefits in lowering blood pressures at one end also predisposes the patients to volume depletionEmpagliflozin 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 diabetes18 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 insulin19 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None