DAPA - Egypt Study

Type-2 Diabetes Clinical Trial

Official title:

Usage of Dapagliflozin - a Sodium Glucose Co-transporter Inhibitor, in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Egyptian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624803
• Other study ID #: D1690R00049
• Status: Completed
• Start date: March 9, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: February 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Approximately 39 million people of adults aged 20-79 are living with Diabetes in MENA region in 2017, Egypt is number 8 in the top 10 countries in number of adults with Diabetes (8.2 million), where Egypt represents 21% of the Diabetics in MENA region.

Metformin is used as 1st line oral anti-diabetic drug in most cases. Sulfonylureas (SU) are used as frequent first add-on after failure of metformin monotherapy. Sodium Glucose Co-transporter 2 (SGLT2) inhibitors are a newer class of therapy which has a lower incidence of hypoglycemia and in addition helps in weight and BP reduction. In Egypt, SGLT2 inhibitors were introduced in 2016. It is not yet widely used for various reasons including lack of wide clinical experience in Egyptian patients and safety concerns particularly related to infections and some rare Diabetic Ketoacidosis (DKA). Also, usage of SGLT2 inhibitors is limited in the early stage of diabetes as they are usually preferred as 3rd or 4th add-on therapy.

The existing dapagliflozin phase-3 clinical trial program on SGLT2 inhibitors didn't include subjects from Egypt. There is no study available which evaluates the effect of dapagliflozin in real world scenario in Egypt. Key opinion leaders in diabetes in Egypt have also identified the need for study on Egyptian subjects to observe the usage pattern and effect of dapagliflozin, a SGLT2 inhibitor, in this specific real world setting. Therefore, there is a need for data on real world setting across Egypt. With this aim in mind, the present study has been planned.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients with 18 years and above.

2. Patients who provide written informed consent.

3. Patients with previously diagnosed Type-2 diabetes mellitus

4. Patients with inadequately controlled diabetes (HbA1c>7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.

5. Patients who initiated dapagliflozin at least 3 months prior to the date of study start.

6. Patients who are having past medical records for demographic information, weight, blood pressure, HbA1c value, and concomitant medications at the time of dapagliflozin prescribed.

Exclusion Criteria:

1. Patients with Type-1 diabetes mellitus.

2. Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study

3. Pregnant or lactating women

4. Patients with other severe conditions/elements which require / may require hospitalization, during study participation period

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type-2 Diabetes

Locations

Country	Name	City	State
Egypt	Research Site	Alexandria
Egypt	Research Site	Assuit
Egypt	Research Site	Behira
Egypt	Research Site	Cairo
Egypt	Research Site	El Rehab
Egypt	Research Site	Fiasal
Egypt	Research Site	Giza
Egypt	Research Site	Haram
Egypt	Research Site	Heliopolis
Egypt	Research Site	Maadi
Egypt	Research Site	Manial
Egypt	Research Site	Mansoura
Egypt	Research Site	Mansoura
Egypt	Research Site	Mohandesin
Egypt	Research Site	Mohandessin
Egypt	Research Site	Nasr City
Egypt	Research Site	Nozha
Egypt	Research Site	Sharkia
Egypt	Research Site	Sohag
Egypt	Research Site	Tanta
Egypt	Research Site	West Lbalad

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe baseline characteristics of patients starting Dapagliflozin together with other anti-diabetic medications , alone or in combination. And to describe if Dapagliflozin was given as 2nd line , 3rd line or later in combination therapy.	To describe baseline characteristics of patients starting Dapagliflozin together with other anti-diabetic medications , alone or in combination. And to describe if Dapagliflozin was given as 2nd line , 3rd line or later in combination therapy.; "The primary end point will record if Dapagliflozin is used as first or second or third line of treatment.; also will record if Dapagliflozin used as mono-therapy or in combination with other anti-diabetic medication stating these medications."	6 months
Secondary	To record the mean change in HbA1C from baseline to months 3 and 6.	To record the mean change in HbA1C from baseline to months 3 and 6.; The Dapagliflozin Egypt's study will enroll patients currently on dapagliflozin at least for 3 months & will follow up these patients for another 3 months, so the total duration is 6 months.	6 months
Secondary	To record the HbA1c change (%) as per different baseline HbA1c levels (<8%, 8-10% and >10%).	To record the HbA1c change (%) as per different baseline HbA1c levels (<8%, 8-10% and >10%).; "Measurement of HbA1c level (%) change from baseline."	6 months
Secondary	To record percentage of patients achieving HbA1c target (less than or equal 7 %)	To record percentage of patients achieving HbA1c target (less than or equal 7 %).; "Measurement of percentage of patients achieving HbA1c target less than or equal 7%."	6 months
Secondary	To record the change in weight (kg) as per different baseline BMI (kg/m2) (<25, 25-30, >30).	To record the change in weight (kg) as per different baseline BMI (kg/m2) (<25, 25-30, >30).; "Measurement the change in weight in Kg from baseline."	6 months
Secondary	To record the change in blood pressure (mmHg) from baseline.	To record the change in blood pressure (mmHg) from baseline.; "Measurement of blood pressure change from baseline in mmHg."	6 months

External Links

•   redacted CSR synopsis