Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Recruiting
Phase 4
Interventional Study
Type II Diabetes Mellitus
Efficacy, Self
Safety Issues
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,000 (estimated)
- Sponsor
- Getz Pharma · Industry
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About This Trial
Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population.
Study design Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
Sample size The estimated sample size will be n=156. Duration of study 12 months (data lock point will be complet…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Patient with T2DM between 18 to 65 years with HbA1C 7% - 10%, who can give informed consent. Patient uncontrolled on oral antidiabetics and lifestyle modification for at least 3 months. Patient who are empagliflozin naive. eGFR ˃60 mL/min/1.73m2.
Exclusion Criteria:
Type 1 dia…
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