Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Afghanistan
Kabul University of Medical Sciences(KUMS)
COMPLETED
Kabul
Kenya
Agha Khan univeristy hospital
RECRUITING
Nairobi
Nigeria
Lagos University Teaching Hospital
RECRUITING
Lagos
Pakistan
Umar Diabetes Foundation
RECRUITING
Islamabad
Sri Lanka
National hospital Sri Lanka
RECRUITING
Colombo
NHK
RECRUITING
Kandy
Contact Information
Primary
Dr. Muhammad Nabeed Tahir
nabeedt@gmail.com
+923015376299
Backup
Dr. Umar Wahab
dromarwahab@yahoo.com
+923339158285
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 2000
Treatments
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
Sponsors
Leads: Getz Pharma

This content was sourced from clinicaltrials.gov