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

Sponsor
Getz Pharma
Study ID
NCT05164263
Phase
PHASE4
Status
Recruiting
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Conditions

  • Efficacy, Self
  • Safety Issues
  • Type II Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin — DRUG
    Empagliflozin + Metformin (Diampa™-M): 5mg+500mg, 5mg+850mg, 5mg+1000mg, 12.5mg+1000mg, 12.5mg+500mg, 12.5mg+ 850mg Empagliflozin Alone (Diampa™): 10mg, 25mg

Study Details

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

Key Dates

Start date
Apr 1, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
2,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months
    Type 2 diabetic males \& females between 18-65 years. * HbA1c: 7.0% - 10% * eGFR ˃60 mL/min/1.73m2. * Patient who will give informed consent

Primary Outcome Measure

SAFETY and TOLERABILITY Outcomes [ Time Frame: 6 months ]

Central Contacts

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