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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03764631
Other study ID # 1245-0149
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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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