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Clinical Trial Details

Trial ID: L2135
Source ID: NCT03764631
Associated Drug: Empagliflozin
Title: 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
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03764631/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Empagliflozin|DRUG: Dipeptidyl-peptidase 4 (DPP-4) inhibitors
Outcome Measures: Primary: 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., 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., 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., 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., 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: 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)., 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)., 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)., 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)., Up to day 29.
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 1502
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2018-09-26
Completion Date: 2021-01-11
Results First Posted: 2022-02-10
Last Update Posted: 2022-02-10
Locations: Abha International Private Hospital, Abha, 61431, Saudi Arabia|DAFA Special Polyclinic, Jeddah, 21214, Saudi Arabia|Ghassan Najeeb Pharaon Hospital, Jeddah, 21412, Saudi Arabia|International Medical Center, Jeddah, 21451, Saudi Arabia|Dr.Bakhsh Hospital, Jeddah, 21452, Saudi Arabia|Dr. Soliman Fakeeh Hospital, Jeddah, 21461, Saudi Arabia|Saudi German Hospital, Jeddah, 21461, Saudi Arabia|Al Abeer Medical Center, Jeddah, 21573, Saudi Arabia|Al-Abeer Medical Center, Jeddah, 21573, Saudi Arabia|Al Abeer Polyclinic, Jeddah, 23531, Saudi Arabia|Al Rahman Polyclinic, Makkah, 24232, Saudi Arabia|Shifa Hospital, Makkah, 24232, Saudi Arabia|Al-Noor Specialist Hospital, Makkah, 24241, Saudi Arabia|Al Zafer Hospital, Najran, 66261, Saudi Arabia|Obesity, Endocrine and Metabolism Center, Riyadh, 11525, Saudi Arabia|Riyadh Medical Center, Riyadh, 11533, Saudi Arabia|Alalam Medical Center, Riyadh, 13214, Saudi Arabia|Prince Fahad bin Sultan hospital, Tabuk, 47311, Saudi Arabia|Al Hada Armed Forces Hospital, Taif, 21944, Saudi Arabia|Al Amal Medical Group, Yanbu, 46455, Saudi Arabia|Alansari Specialist Hospital, Yanbu, 46455, Saudi Arabia
URL: https://clinicaltrials.gov/show/NCT03764631