DAPA - Egypt Study

AstraZeneca

Status: Completed

Conditions: Type-2 Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT03624803

D1690R00049

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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