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
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors
- Registration Number
- NCT03764631
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1502
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description subjects with Type 2 Diabetes mellitus Dipeptidyl-peptidase 4 (DPP-4) inhibitors - subjects with Type 2 Diabetes mellitus Empagliflozin -
- Primary Outcome Measures
Name Time Method Number of Participants With Ketoacidosis 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.
Number of Participants With Severe Urinary Tract Infections (UTIs) 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.
Number of Participants With Volume Depletion 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.
Number of Participants With Dehydration 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 Outcome Measures
Name Time Method Number of Participants With Ketoacidosis During Ramadan Periods 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).Number of Participants With Dehydration During Ramadan Periods 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).Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods 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).Number of Participants With Volume Depletion During Ramadan Periods 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).
Trial Locations
- Locations (21)
Dr. Soliman Fakeeh Hospital
🇸🇦Jeddah, Saudi Arabia
Shifa Hospital
🇸🇦Makkah, Saudi Arabia
Prince Fahad bin Sultan hospital
🇸🇦Tabuk, Saudi Arabia
Alansari Specialist Hospital
🇸🇦Yanbu, Saudi Arabia
Abha International Private Hospital
🇸🇦Abha, Saudi Arabia
International Medical Center
🇸🇦Jeddah, Saudi Arabia
Ghassan Najeeb Pharaon Hospital
🇸🇦Jeddah, Saudi Arabia
DAFA Special Polyclinic
🇸🇦Jeddah, Saudi Arabia
Saudi German Hospital
🇸🇦Jeddah, Saudi Arabia
Dr.Bakhsh Hospital
🇸🇦Jeddah, Saudi Arabia
Al-Abeer Medical Center
🇸🇦Jeddah, Saudi Arabia
Al Abeer Medical Center
🇸🇦Jeddah, Saudi Arabia
Al Rahman Polyclinic
🇸🇦Makkah, Saudi Arabia
Al Abeer Polyclinic
🇸🇦Jeddah, Saudi Arabia
Al-Noor Specialist Hospital
🇸🇦Makkah, Saudi Arabia
Obesity, Endocrine and Metabolism Center
🇸🇦Riyadh, Saudi Arabia
Al Zafer Hospital
🇸🇦Najran, Saudi Arabia
Riyadh Medical Center
🇸🇦Riyadh, Saudi Arabia
Alalam Medical Center
🇸🇦Riyadh, Saudi Arabia
Al Hada Armed Forces Hospital
🇸🇦Taif, Saudi Arabia
Al Amal Medical Group
🇸🇦Yanbu, Saudi Arabia