NCT05164263

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for phase_4

Timeline
16mo left

Started Apr 2021

Longer than P75 for phase_4

Geographic Reach
5 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2021Aug 2027

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

December 7, 2021

Last Update Submit

January 20, 2026

Conditions

Type II Diabetes MellitusEfficacy, SelfSafety Issues

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Efficacy outcomes

    6 months

Study Arms (1)

Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months

EXPERIMENTAL

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

Interventions

EmpagliflozinDRUG

Empagliflozin + Metformin (Diampa™-M): 5mg+500mg, 5mg+850mg, 5mg+1000mg, 12.5mg+1000mg, 12.5mg+500mg, 12.5mg+ 850mg Empagliflozin Alone (Diampa™): 10mg, 25mg

Empagliflozin naive uncontrolled T2DM on oral anti-diabetics & lifestyle modifications for 3 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kabul University of Medical Sciences(KUMS)

Kabul, Afghanistan, Afghanistan

COMPLETED

Agha Khan univeristy hospital

Nairobi, Kenya, Kenya

RECRUITING

Lagos University Teaching Hospital

Lagos, Nigeria, Nigeria

RECRUITING

Umar Diabetes Foundation

Islamabad, Pakistan

COMPLETED

National hospital Sri Lanka

Colombo, Colombo, Sri Lanka

COMPLETED

NHK

Kandy, Kandy, Sri Lanka

COMPLETED

Related Publications (2)

  • 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.

    PMID: 27289126BACKGROUND

  • 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.

    PMID: 24795251BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Umar Wahab

    Umar Diabetes Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Muhammad Nabeed Tahir

CONTACT

+923015376299nabeedt@gmail.com

Dr. Umar Wahab

CONTACT

+923339158285dromarwahab@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2021

First Posted

December 20, 2021

Study Start

April 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Upon request

Locations

KE(1)AF(1)PA(1)SR(2)NG(1)