NCT04665284

Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 244 (actual)
• Sponsor: Getz Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Empagliflozin	Group A: Empagliflozin 10/25 mg once daily with or without antidiabetic drugs
DRUG	Usual care group	Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-09-15
• Completion: 2020-09-28
• First posted: 2020-12-11
• Last updated: 2020-12-11

Locations

11 sites across 1 country: Pakistan