Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2018-12-05
Enrollment: 1502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Main diagnosis for study entry

-Patients diagnosed with T2DM will be included.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Ketoacidosis
timeFrame: 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).
measure: Number of Participants With Severe Urinary Tract Infections (UTIs)
timeFrame: 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).
measure: Number of Participants With Volume Depletion
timeFrame: 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).
measure: Number of Participants With Dehydration
timeFrame: 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:
measure: Number of Participants With Ketoacidosis During Ramadan Periods
timeFrame: Up to day 29.
measure: Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods
timeFrame: Up to day 29.
measure: Number of Participants With Volume Depletion During Ramadan Periods
timeFrame: Up to day 29.
measure: Number of Participants With Dehydration During Ramadan Periods
timeFrame: Up to day 29.
Other outcomes:
Locations:
city: Abha
country: Saudi Arabia
facility: Abha International Private Hospital
city: Jeddah
country: Saudi Arabia
facility: DAFA Special Polyclinic
city: Jeddah
country: Saudi Arabia
facility: Ghassan Najeeb Pharaon Hospital
city: Jeddah
country: Saudi Arabia
facility: International Medical Center
city: Jeddah
country: Saudi Arabia
facility: Dr.Bakhsh Hospital
city: Jeddah
country: Saudi Arabia
facility: Dr. Soliman Fakeeh Hospital
city: Jeddah
country: Saudi Arabia
facility: Saudi German Hospital
city: Jeddah
country: Saudi Arabia
facility: Al Abeer Medical Center
city: Jeddah
country: Saudi Arabia
facility: Al-Abeer Medical Center
city: Jeddah
country: Saudi Arabia
facility: Al Abeer Polyclinic
city: Makkah
country: Saudi Arabia
facility: Al Rahman Polyclinic
city: Makkah
country: Saudi Arabia
facility: Shifa Hospital
city: Makkah
country: Saudi Arabia
facility: Al-Noor Specialist Hospital
city: Najran
country: Saudi Arabia
facility: Al Zafer Hospital
city: Riyadh
country: Saudi Arabia
facility: Obesity, Endocrine and Metabolism Center
city: Riyadh
country: Saudi Arabia
facility: Riyadh Medical Center
city: Riyadh
country: Saudi Arabia
facility: Alalam Medical Center
city: Tabuk
country: Saudi Arabia
facility: Prince Fahad bin Sultan hospital
city: Taif
country: Saudi Arabia
facility: Al Hada Armed Forces Hospital
city: Yanbu
country: Saudi Arabia
facility: Al Amal Medical Group
city: Yanbu
country: Saudi Arabia
facility: Alansari Specialist Hospital
Study officials:
affiliation: ahmed.mansour@boehringer-ingelheim.com
name: Ahmed Mansour, +201028866717
role: STUDY_CHAIR
References: