Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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 2045.1 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, 16.98% of the Pakistani population has diabetes.4 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 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.
    

Intervention name(s): Empagliflozin; Usual care group
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Group A; Group B
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment