Clinical trial NCT05164263: Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study
Official title: Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in Patients With Type II Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type II Diabetes Mellitus
Efficacy, Self
Safety Issues
Lead sponsor: Getz Pharma
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: SAFETY and TOLERABILITY Outcomes
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Umar Diabetes Foundation
city: Colombo
country: Sri Lanka
facility: NHSL
city: Kandy
country: Sri Lanka
facility: NHK
Study officials:
affiliation: Umar Diabetes Foundation
name: Umar Wahab
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.