Diabete Type 2NCT06117449
Insulin Therapy in Type 2 Diabetic Patients: Real-life Study on Effectiveness and Satisfaction
An observational study of Diabete Type 2, run by Assiut University.
Trial summary
Diabetes mellitus is an endocrine disorder with heterogeneous etiologies, which is characterized by raised levels of glucose in a person's blood and disturbances of macromolecules such as carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Epi Info STATCALC was used to calculate the sample size by considering the following assumptions: - 95% two-sided confidence level, with a power of 80%. \& An error of 5% odds ratio calculated= 1.115. The final maximum sample size taken from the Epi- Info output was 91. By assuming a 10% drop out cases during follow up, the sample size was increased to 100 cases. X = Z(c/100)^2 r(100-r) N = N x/((N-1)E2 + x) E = Sqrt[(N - n)x/n(N-1)] Where N is the population size, r is the fraction of responses that you are interested in, and Z(c/100) is the critical value for the confidence level c.
Who may be able to join
- -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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Loubna Eltony, prof contact
About this study
Official title: Effectiveness and Satisfaction of Insulin Therapy in Type 2 Diabetic Patients (Real Life Study)
Diabetes mellitus is an endocrine disorder with heterogeneous etiologies, which is characterized by raised levels of glucose in a person's blood and disturbances of macromolecules such as carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both.
A lack of insulin, or the inability of cells to respond to it, leads to high levels of blood glucose (hyperglycemia), which is the clinical indicator of diabetes. Type 1 DM is characterized by insulin deficiency and a tendency to develop diabetic ketoacidosis, whereas type 2 DM is characterized by variable degrees of insulin resistance, impaired insulin secretion, and excessive hepatic glucose produc Tion. Diabetes is one of the most rapidly increasing chronic diseases and an important public health problem all over the world. The global burden of diabetes is rising dramatically worldwide. Type 2 diabetes is the most common type of diabetes, accounting for around 90% of all diabetes worldwide (IDF). The prevalence of type 2 diabetes is high and rising across all regions. This rise is driven by increasing life expectancy, economic development, and increasing urbanization leading to more sedentary lifestyles and greater consumption of unhealthy foods linked with obesity.
Type 2 diabetes prevalence has increased in Egypt during the past few years. Egypt is one of the top ten nations with the greatest proportion of adults with diabetes, according to the International Diabetes Federation. In Egypt, the prevalence of diabetes was projected to be 9.6 million, with type 2 diabetes making up the bulk of cases .
- Conditions
- Diabete Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients going on insulin therapy | Not described | |
| patients going on oral antidiabetic drugs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose level
comparison of blood glucose level on patients who going on insulin therapy with patient going on oral antidiabetic
Measured: baseline
HbA1C level
comparison of HbA1C level on patients who going on insulin therapy with patient going on oral antidiabetic
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Apr 2025 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ashraf Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117449
- Sponsor's protocol ID
- ESITT2DP
- Status last verified
- Jul 2024
- First submitted
- 29 Oct 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsner RH. California bureaucrats propose control of excess physicians. Fed Bull. 1979 May;66(5):140-1. No abstract available.
PubMed 10241716Witek TJ Jr. The nose as a target for adverse effects from the environment: applying advances in nasal physiologic measurements and mechanisms. Am J Ind Med. 1993 Nov;24(5):649-57. doi: 10.1002/ajim.4700240512. No abstract available.
PubMed 8266937Ishii H, Terauchi Y, Jinnouchi H, Taketsuna M, Takeuchi M, Imaoka T. Effects of insulin changes on quality of life and glycemic control in Japanese patients with type 2 diabetes mellitus: The insulin-changing study intending to gain patients' insights into insulin treatment with patient-reported health outcomes in actual clinical treatments (INSIGHTs) study. J Diabetes Investig. 2013 Nov 27;4(6):560-70. doi: 10.1111/jdi.12086. Epub 2013 Apr 30.
PubMed 24843710
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Satisfaction of Insulin Therapy in Type 2 Diabetic Patients (Real Life Study)
- ClinicalTrials.gov ID
- NCT06117449
- Acronym / sponsor ID
- ESITT2DP
- Conditions
- Diabete Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes mellitus is an endocrine disorder with heterogeneous etiologies, which is characterized by raised levels of glucose in a person's blood and disturbances of macromolecules such as carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both.
A lack of insulin, or the inability of cells to respond to it, leads to high levels of blood glucose (hyperglycemia), which is the clinical indicator of diabetes. Type 1 DM is characterized by insulin deficiency and a tendency to develop diabetic ketoacidosis, whereas type 2 DM is characterized by variable degrees of insulin resistance, impaired insulin secretion, and excessive hepatic glucose produc Tion. Diabetes is one of the most rapidly increasing chronic diseases and an important public health problem all over the world. The global burden of diabetes is rising dramatically worldwide. Type 2 diabetes is the most common type of diabetes, accounting for around 90% of all diabetes worldwide (IDF). The prevalence of type 2 diabetes is high and rising across all regions. This rise is driven by increasing life expectancy, economic development, and increasing urbanization leading to more sedentary lifestyles and greater consumption of unhealthy foods linked with obesity.
Type 2 diabetes prevalence has increased in Egypt during the past few years. Egypt is one of the top ten nations with the greatest proportion of adults with diabetes, according to the International Diabetes Federation. In Egypt, the prevalence of diabetes was projected to be 9.6 million, with type 2 diabetes making up the bulk of cases .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients going on insulin therapy | – | – |
| patients going on oral antidiabetic drugs | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Epi Info STATCALC was used to calculate the sample size by considering the following assumptions: - 95% two-sided confidence level, with a power of 80%. \& An error of 5% odds ratio calculated= 1.115. The final maximum sample size taken from the Epi- Info output was 91. By assuming a 10% drop out cases during follow up, the sample size was increased to 100 cases. X = Z(c/100)^2 r(100-r) N = N x/((N-1)E2 + x) E = Sqrt[(N - n)x/n(N-1)] Where N is the population size, r is the fraction of responses that you are interested in, and Z(c/100) is the critical value for the confidence level c.
Key inclusion criteria (6 listed)
- -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
- 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.
Key exclusion criteria (6 listed)
- Patients had type 1 diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
blood glucose level
Time frame: baseline
comparison of blood glucose level on patients who going on insulin therapy with patient going on oral antidiabetic
HbA1C level
Time frame: baseline
comparison of HbA1C level on patients who going on insulin therapy with patient going on oral antidiabetic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 10241716Elsner RH. California bureaucrats propose control of excess physicians. Fed Bull. 1979 May;66(5):140-1. No abstract available.
- Background: PubMed 8266937Witek TJ Jr. The nose as a target for adverse effects from the environment: applying advances in nasal physiologic measurements and mechanisms. Am J Ind Med. 1993 Nov;24(5):649-57. doi: 10.1002/ajim.4700240512. No abstract available.
- Background: PubMed 24843710Ishii H, Terauchi Y, Jinnouchi H, Taketsuna M, Takeuchi M, Imaoka T. Effects of insulin changes on quality of life and glycemic control in Japanese patients with type 2 diabetes mellitus: The insulin-changing study intending to gain patients' insights into insulin treatment with patient-reported health outcomes in actual clinical treatments (INSIGHTs) study. J Diabetes Investig. 2013 Nov 27;4(6):560-70. doi: 10.1111/jdi.12086. Epub 2013 Apr 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loubna Eltony, prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Ashraf (01154727599 ext. +20, esraaelshenawy8497@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose level (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06117449, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.