Real World Safety & Efficacy Experience of Empagliflozin With or Without

Status Recruiting

Clinical Trial Summary

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 completion of 6 months' follow-up from the time of last patient's enrollment date) Safety Assessment: Patient will be monitored for Hypoglycemia, Dehydration, Hypotension, Urinary Tract Infections, Fungal Infections, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion and Other side effects (if any). Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. LABORATORY TESTING: Reputable Lab is considered for laboratory testing of diabetes patients i.e. HbA1C%, FBG, RFT and urine R/E. The certified clinical lab will be responsible for receiving and analyzing clinical sample. Patients will have special discount of upto 50% for study related laboratory investigations. Where in Urine Routine Examination (Urine R/E), we consider as follows: - Visual Examination: - Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other. - Urine clarity: Clear, slightly Cloudy, cloudy or turbidity - Chemical Examination: - Specific gravity - pH - Bilirubin - Urobilinogen - Protein - Ketone - Leukocyte Esterase - Microscopic Examination: - Red Blood Cells: - Epithelial Cells: - Amorphous: - Pus Cells - Bacteria - Yeast - Casts - Crystals Where in Renal Function Test (RFT), we consider as follows: - Blood Urea Nitrogen (BUN): mg/dL - Serum Creatinine: mg/dL - Estimated Glomerular Filtration Rate (eGFR): mL/min/1.73 m2

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05164263
Study type	Interventional
Source	Getz Pharma
Contact	Syed Hussain Abidi
Phone	+923322583236
Email	mdr.hussainabidi@gmail.com
Status	Recruiting
Phase	Phase 4
Start date	April 1, 2021
Completion date	March 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study — EASE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms