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

NCT05164263 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-01-22

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Getz Pharma

    lead INDUSTRY

Principal Investigators

  • Umar Wahab · Umar Diabetes Foundation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2026-12-31
Completion
2027-08-31

Countries

  • Afghanistan
  • Kenya
  • Nigeria
  • Pakistan
  • Sri Lanka

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164263 on ClinicalTrials.gov