Efficacy, Safety, Tolerability
Conditions
Keywords
Efficacy, Safety, Tolerability, Ertugliflozin, Sitgliptin
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.
Interventions
DRUGCombinations of Oral Blood Glucose Lowering Drugs
Combination of Ertugliflozin and Sitagliptin
Sponsors
Primary Care Diabetes Association, Pakistan
Getz Pharma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in bodyweight & BMI | till 24 weeks | Efficacy |
| Change from baseline in HbA1c% to the last-observation. | up to 24 weeks | Efficacy |
| Change from baseline in fasting plasma glucose to the last- observation on treatment | 24 weeks | Efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events during the course of study follow-up | 24 weeks | Safety |
| Frequency of serious adverse events | up to 24 weeks | Safety |
| Percentage of patients who discontinued investigational drug due to adverse events | up to 24 weeks | Tolerability |
Countries
Pakistan
Outcome results
None listed