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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764631
• Other study ID #: 1245-0149
• Status: Completed
• Start date: September 26, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: February 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1502
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypovolemia
• Ketosis
• Urinary Tract Infections

Intervention

Drug:
• Empagliflozin
Drug
• Dipeptidyl-peptidase 4 (DPP-4) inhibitors
Dipeptidyl-peptidase 4 - Drug

Locations

Country	Name	City	State
Saudi Arabia	Abha International Private Hospital	Abha
Saudi Arabia	Al Abeer Medical Center	Jeddah
Saudi Arabia	Al Abeer Polyclinic	Jeddah
Saudi Arabia	Al-Abeer Medical Center	Jeddah
Saudi Arabia	DAFA Special Polyclinic	Jeddah
Saudi Arabia	Dr. Soliman Fakeeh Hospital	Jeddah
Saudi Arabia	Dr.Bakhsh Hospital	Jeddah
Saudi Arabia	Ghassan Najeeb Pharaon Hospital	Jeddah
Saudi Arabia	International Medical Center	Jeddah
Saudi Arabia	Saudi German Hospital	Jeddah
Saudi Arabia	Al Rahman Polyclinic	Makkah
Saudi Arabia	Al-Noor Specialist Hospital	Makkah
Saudi Arabia	Shifa Hospital	Makkah
Saudi Arabia	Al Zafer Hospital	Najran
Saudi Arabia	Alalam Medical Center	Riyadh
Saudi Arabia	Obesity, Endocrine and Metabolism Center	Riyadh
Saudi Arabia	Riyadh Medical Center	Riyadh
Saudi Arabia	Prince Fahad bin Sultan hospital	Tabuk
Saudi Arabia	Al Hada Armed Forces Hospital	Taif
Saudi Arabia	Al Amal Medical Group	Yanbu
Saudi Arabia	Alansari Specialist Hospital	Yanbu

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).
Primary	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).
Primary	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).
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.

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