Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study

Getz Pharma

Status: Completed

Conditions: Efficacy; Tolerability; Safety

Treatments: Drug: Combinations of Oral Blood Glucose Lowering Drugs

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05556291

GTZ-DM-006-22

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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