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Type-2 DiabetesNCT03624803

DAPA - Egypt Study

An observational study of Type-2 Diabetes, run by AstraZeneca at 21 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type-2 Diabetes
How many people
200 participants
Where
21 sitesEgypt
Study dates
9 Mar 2019to 30 Mar 2020
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
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • Male or female patients with 18 years and above.
  • Patients who provide written informed consent.
  • Patients with previously diagnosed Type-2 diabetes mellitus
  • Patients with inadequately controlled diabetes (HbA1c>7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.
  • Patients who initiated dapagliflozin at least 3 months prior to the date of study start.
  • Patients who are having past medical records for demographic information, weight, blood pressure, HbA1c value, and concomitant medications at the time of dapagliflozin prescribed.

Who cannot join

  • Patients with Type-1 diabetes mellitus.
  • Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study
  • Pregnant or lactating women
  • Patients with other severe conditions/elements which require / may require hospitalization, during study participation period

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Egypt21 sites

  • Research Site

    Al Mansurah, D1690R00049

  • Research Site

    Al Mansurah, D1690R00051

  • Research Site

    Alexandria, D1690R00049

  • Research Site

    Asyut, D1690R00049

  • Research Site

    Behira, Egypt, D1690R00050

  • Research Site

    Cairo, D1690R00053

  • Research Site

    El Rehab, Egypt, D1690R00049

  • Research Site

    Fiasal, Egypt, D1690R00049

  • Research Site

    Giza, D1690R00049

  • Research Site

    Haram, Egypt, D1690R00049

  • Research Site

    Heliopolis, D1690R00049

  • Research Site

    Maadi, D1690R00049

  • Research Site

    Madīnat an Naşr, Egypt, D1690R00049

  • Research Site

    Manial, Egypt, D1690R00049

  • Research Site

    Mohandesin, Egypt, D1690R00049

  • Research Site

    Mohandessin, D1690R00049

  • Research Site

    Nozha, Egypt, D1690R00049

  • Research Site

    Sharkia, Egypt, D1690R00049

  • Research Site

    Sohag, D1690R00049

  • Research Site

    Tanta, D1690R00049

  • Research Site

    West Lbalad, Egypt, D1690R00049

Other trials in Egypt

About this 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

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.

Conditions
Type-2 Diabetes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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."

    Measured: 6 months

Secondary outcomes (5)

  1. 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.

    Measured: 6 months

  2. 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."

    Measured: 6 months

  3. 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%."

    Measured: 6 months

  4. 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."

    Measured: 6 months

  5. 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."

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start9 Mar 2019
  3. Primary completion30 Mar 2020
  4. Study completion30 Mar 2020

Resources

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
Other
Time perspective
Other
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624803
Sponsor's protocol ID
D1690R00049
Status last verified
Feb 2021
First submitted
30 Jul 2018
Last updated
10 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Type-2 Diabetes, run by AstraZeneca at 21 sites in Egypt.

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 4 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: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 6 months). 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 NCT03624803.

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 10 Feb 2021.

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