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

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

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

Study Overview

• Status: Recruiting
• Conditions: Type II Diabetes Mellitus; Safety Issues; Efficacy, Self
• Intervention / Treatment: Drug: Empagliflozin

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Syed Hussain Abidi; Phone Number: +923322583236; Email: mdr.hussainabidi@gmail.com
• Study Contact Backup: Name: Umar Wahab; Phone Number: +923339158285; Email: dromarwahab@yahoo.com

Study Locations

• Pakistan
  • Islamabad, Pakistan
    • Recruiting
    • Umar Diabetes Foundation
    • Contact: Umar Wahab; Phone Number: +923339158285; Email: dromarwahab@yahoo.com
• Sri Lanka
  • Colombo, Sri Lanka
    • Active, not recruiting
    • NHSL
  • Kandy, Sri Lanka
    • Recruiting
    • NHK
    • Contact: Charles Antonypillae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Empagliflozin; Empagliflozin + Metformin (Diampa™-M): 5mg+500mg, 5mg+850mg, 5mg+1000mg, 12.5mg+1000mg, 12.5mg+500mg, 12.5mg+ 850mg Empagliflozin Alone (Diampa™): 10mg, 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAFETY and TOLERABILITY Outcomes	Frequency of adverse events, serious adverse events during the course of study follow-up. Percentage of patients who tolerate empagliflozin.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy outcomes	Change from baseline in HbA1c% and fasting plasma glucose to the last-observation on treatment. Change from baseline in bodyweight & other study parameters.	6 months

Collaborators and Investigators

• Sponsor: Getz Pharma

Publications and helpful links

General Publications

• Ferrannini E, Mark M, Mayoux E. CV Protection in the EMPA-REG OUTCOME Trial: A "Thrifty Substrate" Hypothesis. Diabetes Care. 2016 Jul;39(7):1108-14. doi: 10.2337/dc16-0330.
• Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): March 31, 2025

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (ACTUAL): December 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Empagliflozin
• Other Study ID Numbers: GTZ-DM-003-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No