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NCT05556291 | Recruiting | Efficacy

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

Getz Pharma

Brief Summary:

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.

Condition or disease

Efficacy

Safety

Tolerability

Intervention/treatment

Combinations of Oral Blood Glucose Lowering Drugs

Study Type : Observational
Estimated Enrollment : 190 participants
Official Title : Efficacy, Safety and Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus
Actual Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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
Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Pakistan, Sindh

Doctor's Plaza

Karachi, Sindh, Pakistan, 75330

Recruiting

Pakistan, Sindh

Khan's Clinic

Karachi, Sindh, Pakistan, 75330

Recruiting

Pakistan, Sindh

PECHS

Karachi, Sindh, Pakistan, 75330