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

Safety Issues Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164263
• Other study ID #: GTZ-DM-003-21
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2023
• Source: Getz Pharma
• Contact: Syed Hussain Abidi
• Phone: +923322583236
• Email: mdr.hussainabidi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Efficacy, Self
• Safety Issues
• Type II Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Pakistan	Umar Diabetes Foundation	Islamabad
Sri Lanka	NHSL	Colombo
Sri Lanka	NHK	Kandy

Sponsors (1)

Lead Sponsor	Collaborator
Getz Pharma

Countries where clinical trial is conducted

Pakistan,  Sri Lanka, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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