Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus

GTZ-DM-006-22

Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study to evaluate the efficacy, safety and tolerability of Ertugliflozin and Sitagliptin Con-initiation in patients with Type II Diabetes Mellitus in the Pakistani population. The study duration will be 12 months.

2022-12-01

2023-12-01

2023-12-01

Recruiting

190

Inclusion Criteria: * Type 2 diabetic males \& females between 18-65 years. * HbA1c: 7.0% - 10.0% * Patient uncontrolled on oral anti-diabetics and lifestyle modifications for at least 3 months. * eGFR \>60 mL/min/1.73m2. * Patient who will give informed consent * Patient who are SGLT2i naïve Exclusion Criteria: * History of severe hypoglycemia for the last three months (\<70mg/dL) * Pregnant or lactating females * History of renal and/or hepatic dysfunctions, where RFT and Urine R/E is abnormal * History of recurrent urinary tract infection (UTI) and/or past 3 months' history of UTI and its treatment * Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state. * History of acute coronary syndrome or myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack. * History of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease * Patient with diabetic foot ulcers

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 190, 'type': 'ESTIMATED'}}

2023-02-08