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.
Study Type
OBSERVATIONAL
Enrollment
190
Combination of Ertugliflozin and Sitagliptin
Doctor's Plaza
Karachi, Sindh, Pakistan
Khan's Clinic
Karachi, Sindh, Pakistan
PECHS
Karachi, Sindh, Pakistan
Change from baseline in HbA1c% to the last-observation.
Efficacy
Time frame: up to 24 weeks
Change from baseline in fasting plasma glucose to the last- observation on treatment
Efficacy
Time frame: 24 weeks
Change from baseline in bodyweight & BMI
Efficacy
Time frame: till 24 weeks
Frequency of adverse events during the course of study follow-up
Safety
Time frame: 24 weeks
Frequency of serious adverse events
Safety
Time frame: up to 24 weeks
Percentage of patients who discontinued investigational drug due to adverse events
Tolerability
Time frame: up to 24 weeks
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