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Assessment of Insulin Therapy Effectiveness in Type 2 Diabetes Patients

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Study Aim

This study aims to observe and compare the blood glucose and HbA1C levels in type 2 diabetes patients who are undergoing insulin therapy with those who are using oral antidiabetic medication.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2025
See protocol details

Summary

Principal SponsorAssiut University
Study ContactEsraa AshrafMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2025

Actual date on which the first participant was enrolled.

Diabetes is a health condition where the body either doesn't produce enough insulin or can't effectively use the insulin it does produce. This leads to high levels of sugar, or glucose, in the blood. Type 2 diabetes is the most common form, making up about 90% of all diabetes cases worldwide. This condition is becoming increasingly prevalent, especially in Egypt, which is among the top ten countries with the highest proportion of adults with diabetes. The study focuses on Type 2 diabetes patients in Egypt, aiming to understand and improve their treatment. This observational study compares the effectiveness of insulin therapy and oral anti-diabetic medication in managing Type 2 diabetes. It measures two primary outcomes: blood glucose levels and HbA1C levels. Blood glucose levels are a snapshot of the amount of sugar in the blood at a given time, while HbA1C levels provide an average measure of blood sugar control over a longer period. By comparing these levels in patients using insulin therapy and those using oral medication, the study aims to provide insights into which treatment approach is more effective.

Official TitleEffectiveness and Satisfaction of Insulin Therapy in Type 2 Diabetic Patients (Real Life Study)
NCT06117449
Principal SponsorAssiut University
Study ContactEsraa AshrafMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion Criteria: -Patients with type 2 diabetes mellitus aged ≥18 years. * Patients going on insulin therapy versus patients going on oral antidiabetic drugs. * patients included if they met the following Criteria: * previous diagnosis of diabetes mellitus or on medical therapy of DM. * no prescription fills for a basal insulin containing product in the 1-year pre index date period; and no prescription fills for bolus insulin or mixed insulin products on index date or in the 1-year pre-index date periods. Exclusion Criteria: * Patients had type 1 diabetes mellitus. * Pregnant patients. * Incapable of completing the study questionnaires. * were pregnant at any time during the pre-or post-index periods; or * were diagnosed with any other type of diabetes during the study period, including, gestational diabetes , secondary diabetes , or other abnormal glu-cose conditions . * Patients who were con-comitantly participating in another trial or receiving insulin treatment for reasons other than T2DM.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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