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Completed

NCT Number: NCT03764631

Post-authorization Safety Study in Type 2 Diabetic Patients in Saudi Arabia Treated With Empagliflozin to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration

The objectives of this study are to assess the risk of ketoacidosis, severe urinary tract infections, volume depletion, and dehydration associated in patients with T2DM initiating Empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over a 12-month period of follow-up, including the month of Ramadan

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abha International Private Hospital, Abhā, Saudi Arabia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have signed Informed consent form.
  • The patients will be at least 18 years old at index date, diagnosed with Type 2 diabetes mellitus (T2DM) in Saudi Arabia, and who will initiate Empagliflozin or Dipeptidyl-peptidase 4 (DPP4) inhibitors treatment according to the local label and at the discretion of the treating physician during the study period, who have not used other sodium/glucose co-transporter 2 (SGLT2) or DPP4 inhibitors during the previous 12 months.

Exclusion criteria

  • Known hypersensitivity to Empagliflozin, the comparator DPP-4 inhibitors or any of their excipients
  • Patients for whom Empagliflozin or the comparator DPP-4 inhibitor is contraindicated according Saudi Food and Drug Authority (SFDA) approved label
  • Patients prescribed fixed-dose combinations of SGLT2 inhibitors with DPP-4 inhibitors will be excluded.
  • The same inclusion and exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.

Treatment and study plan

Empagliflozin

Drug

Drug

Dipeptidyl-peptidase 4 (DPP-4) inhibitors

Drug

Dipeptidyl-peptidase 4 - Drug

Primary outcomes

  1. Number of Participants With Ketoacidosis

    Time frame: Up to 12 months after the index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).

    Ketoacidosis is defined as a serious complication of diabetes characterized by high levels of ketones in the body due to lack of insulin and low food intake.

  2. Number of Participants With Severe Urinary Tract Infections (UTIs)

    Time frame: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).

    Severe UTIs is defined as pyelonephritis or urosepsis.

  3. Number of Participants With Volume Depletion

    Time frame: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).

    Volume depletion is defined as the reduction in the extracellular fluids.

  4. Number of Participants With Dehydration

    Time frame: Up to 12 months after index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor).

    Dehydration is defined as the loss of total body water that leads to hypertonicity.

Secondary outcomes

  1. Number of Participants With Ketoacidosis During Ramadan Periods

    Time frame: Up to day 29.

    Ketoacidosis is defined as a serious complication of diabetes characterized by high level of ketones in the body due to lack of insulin and low food intake.

    Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:

    • Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
    • Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).

  2. Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods

    Time frame: Up to day 29.

    Severe UTIs is defined as pyelonephritis or urosepsis.

    Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:

    • Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
    • Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).

  3. Number of Participants With Volume Depletion During Ramadan Periods

    Time frame: Up to day 29.

    Volume depletion is defined as the reduction in the extracellular fluids.

    Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:

    • Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
    • Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).

  4. Number of Participants With Dehydration During Ramadan Periods

    Time frame: Up to day 29.

    Dehydration is defined as the loss of total body water that leads to hypertonicity.

    Ramadan period is defined as the first day of Ramadan to 29th day of Ramadan based on the Islamic Hijri calendar. The following Ramadan periods were included in this study:

    • Ramadan month 2019: 5. May to 4. Jun 2019 (± 1 to 2 days)
    • Ramadan month 2020: 23. April to 23. May 2020 (± 1 to 2 days).

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post-authorization Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration Among Patients Treated With Empagliflozin or DPP-4 Inhibitors in Saudi Arabia

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 5, 2018
Registry last updated
Feb 10, 2022

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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