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
NCT ID: NCT03764631
Last Updated: 2022-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
1502 participants
OBSERVATIONAL
2018-09-26
2021-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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subjects with Type 2 Diabetes mellitus
Empagliflozin
Drug
Dipeptidyl-peptidase 4 (DPP-4) inhibitors
Dipeptidyl-peptidase 4 - Drug
Interventions
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Empagliflozin
Drug
Dipeptidyl-peptidase 4 (DPP-4) inhibitors
Dipeptidyl-peptidase 4 - Drug
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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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
Al Rahman Polyclinic
Mecca, , Saudi Arabia
Shifa Hospital
Mecca, , Saudi Arabia
Al-Noor Specialist Hospital
Mecca, , Saudi Arabia
Al Zafer Hospital
Najrān, , Saudi Arabia
Obesity, Endocrine and Metabolism Center
Riyadh, , Saudi Arabia
Riyadh Medical Center
Riyadh, , Saudi Arabia
Alalam Medical Center
Riyadh, , Saudi Arabia
Al Hada Armed Forces Hospital
Ta'if, , Saudi Arabia
Prince Fahad bin Sultan hospital
Tabuk, , Saudi Arabia
Al Amal Medical Group
Yanbu, , Saudi Arabia
Alansari Specialist Hospital
Yanbu, , Saudi Arabia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1245-0149
Identifier Type: -
Identifier Source: org_study_id
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