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Completed

NCT Number: NCT03624803

DAPA - Egypt Study

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.

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Key information

Conditions

Type-2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Behira, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  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.

    Time frame: 6 months

    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."

Secondary outcomes

  1. To record the mean change in HbA1C from baseline to months 3 and 6.

    Time frame: 6 months

    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.

  2. To record the HbA1c change (%) as per different baseline HbA1c levels (<8%, 8-10% and >10%).

    Time frame: 6 months

    To record the HbA1c change (%) as per different baseline HbA1c levels (<8%, 8-10% and >10%).

    "Measurement of HbA1c level (%) change from baseline."

  3. To record percentage of patients achieving HbA1c target (less than or equal 7 %)

    Time frame: 6 months

    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%."

  4. To record the change in weight (kg) as per different baseline BMI (kg/m2) (<25, 25-30, >30).

    Time frame: 6 months

    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."

  5. To record the change in blood pressure (mmHg) from baseline.

    Time frame: 6 months

    To record the change in blood pressure (mmHg) from baseline.

    "Measurement of blood pressure change from baseline in mmHg."

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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