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

Study Overview
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Brief Summary
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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.

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

Conditions
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Efficacy, Safety, Tolerability

Intervention / Treatment
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* Drug: Combinations of Oral Blood Glucose Lowering Drugs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Combinations of Oral Blood Glucose Lowering Drugs|Combination of Ertugliflozin and Sitagliptin|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c% to the last-observation. | Efficacy | up to 24 weeks | 
| Change from baseline in fasting plasma glucose to the last- observation on treatment | Efficacy | 24 weeks | 
| Change from baseline in bodyweight & BMI | Efficacy | till 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events during the course of study follow-up | Safety | 24 weeks | 
| Frequency of serious adverse events | Safety | up to 24 weeks | 
| Percentage of patients who discontinued investigational drug due to adverse events | Tolerability | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy, Safety, Tolerability, Ertugliflozin, Sitgliptin