NCT05556291Completed
Combination of Ertugliflozin And Sitagliptin Efficacy, Safety & Tolerability (CEASE Diabetes) Study
Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 20 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 190 (actual)
- First submitted
- 23 Sept 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Getz Pharma
- Diseases
- Type 2 diabetes
- NCT number
- NCT05556291
What you commit to
- Study type: Observational
- Participants enrolled: 190
- From 1 Dec 2022 to the primary completion date, 1 Jul 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of severe hypoglycemia for the last three months (\<70mg/dL)
- 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
- 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
Other
- Pregnant or lactating females
- Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.
- Patient with diabetic foot ulcers
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Khan's Clinic Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
| PECHS Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
| Doctor's Plaza Coordinator of this site? Confirm its status | Karachi | Pakistan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.