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

• Status: Completed
• Trial end date: 2020-09-28
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and efficacy of empagliflozin versus other treatments in Pakistani Muslim population with type II diabetes mellitus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Getz Pharma
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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