Clinical trial NCT03624803: DAPA - Egypt Study
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type-2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is a non-interventional, multi centre, retrospective -prospective, observational study to be conducted at up to 50 sites in Egypt. The study targets to enroll 200 patients. The study would enroll T2DM patients who are/were inadequately controlled (HbA1c \>7%) with existing antidiabetic medications and who have been prescribed dapagliflozin at least 3 months prior to study initiation. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice and prescribed dapagliflozin at least 3 months before will be screened for enrolment in study. Dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: To record the mean change in HbA1C from baseline to months 3 and 6.
timeFrame: 6 months
measure: To record the HbA1c change (%) as per different baseline HbA1c levels (<8%, 8-10% and >10%).
timeFrame: 6 months
measure: To record percentage of patients achieving HbA1c target (less than or equal 7 %)
timeFrame: 6 months
measure: To record the change in weight (kg) as per different baseline BMI (kg/m2) (<25, 25-30, >30).
timeFrame: 6 months
measure: To record the change in blood pressure (mmHg) from baseline.
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Research Site
city: Assuit
country: Egypt
facility: Research Site
city: Behira
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: El Rehab
country: Egypt
facility: Research Site
city: Fiasal
country: Egypt
facility: Research Site
city: Giza
country: Egypt
facility: Research Site
city: Haram
country: Egypt
facility: Research Site
city: Heliopolis
country: Egypt
facility: Research Site
city: Maadi
country: Egypt
facility: Research Site
city: Manial
country: Egypt
facility: Research Site
city: Mansoura
country: Egypt
facility: Research Site
city: Mansoura
country: Egypt
facility: Research Site
city: Mohandesin
country: Egypt
facility: Research Site
city: Mohandessin
country: Egypt
facility: Research Site
city: Nasr City
country: Egypt
facility: Research Site
city: Nozha
country: Egypt
facility: Research Site
city: Sharkia
country: Egypt
facility: Research Site
city: Sohag
country: Egypt
facility: Research Site
city: Tanta
country: Egypt
facility: Research Site
city: West Lbalad
country: Egypt
facility: Research Site
Study officials:
References: