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

Boehringer Ingelheim1,502 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,502

Conditions

Diabetes Mellitus, Type 2

Interventions

EmpagliflozinDRUG

Drug

Dipeptidyl-peptidase 4 (DPP-4) inhibitors

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Abha International Private Hospital

Abhā, Saudi Arabia

DAFA Special Polyclinic

Jeddah, Saudi Arabia

Ghassan Najeeb Pharaon Hospital

Jeddah, Saudi Arabia

International Medical Center

Jeddah, Saudi Arabia

Dr.Bakhsh Hospital

Jeddah, Saudi Arabia

Dr. Soliman Fakeeh Hospital

Jeddah, Saudi Arabia

Saudi German Hospital

Jeddah, Saudi Arabia

Al Abeer Medical Center

Jeddah, Saudi Arabia

Al-Abeer Medical Center

Jeddah, Saudi Arabia

Al Abeer Polyclinic

Jeddah, Saudi Arabia

...and 11 more locations

Outcomes

Primary Outcomes

Number of Participants With Ketoacidosis

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.

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).

Number of Participants With Severe Urinary Tract Infections (UTIs)

Severe UTIs is defined as pyelonephritis or urosepsis.

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).

Number of Participants With Volume Depletion

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

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).

Number of Participants With Dehydration

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

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).

Secondary Outcomes

Number of Participants With Ketoacidosis During Ramadan Periods

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).

Time frame: Up to day 29.

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

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).

Time frame: Up to day 29.

Number of Participants With Volume Depletion During Ramadan Periods

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).

Time frame: Up to day 29.

Number of Participants With Dehydration During Ramadan Periods

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).

Time frame: Up to day 29.