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

Getz Pharma

Status and phase: Enrolling; Phase 4

Conditions: Type II Diabetes Mellitus; Safety Issues; Efficacy, Self

Treatments: Drug: Empagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05164263

GTZ-DM-003-21

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 diabetes, History of recurrent urinary tract infection (UTI), fungal infection, renal and/or hepatic dysfunctions, where RFT and Urine R/E is abnormal, Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state, severe hypoglycemia, Pregnant or lactating women, Pancreatitis, any serious complications or hypersensitivity.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months

Experimental group

Description:

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

Treatment:

Drug: Empagliflozin