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

NCT03764631 | Completed Results FDA Drug

• 1 other identifier: 1245-0149
• Study Type: observational
• Target: 1,502
• Locations: 1 country
• Sites: 21

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Number of Participants With Ketoacidosis During Ramadan Periods

  Up to day 29.

• Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods

  Up to day 29.

• Number of Participants With Volume Depletion During Ramadan Periods

  Up to day 29.

• Number of Participants With Dehydration During Ramadan Periods

  Up to day 29.

Study Arms (1)

subjects with Type 2 Diabetes mellitus

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

Interventions

Empagliflozin DRUG

Drug

subjects with Type 2 Diabetes mellitus

Dipeptidyl-peptidase 4 (DPP-4) inhibitors DRUG

Dipeptidyl-peptidase 4 - Drug

subjects with Type 2 Diabetes mellitus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Main diagnosis for study entry -Patients diagnosed with T2DM will be included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (21)

Abha International Private Hospital

Abhā, 61431, Saudi Arabia

Location

DAFA Special Polyclinic

Jeddah, 21214, Saudi Arabia

Location

Ghassan Najeeb Pharaon Hospital

Jeddah, 21412, Saudi Arabia

Location

International Medical Center

Jeddah, 21451, Saudi Arabia

Location

Dr.Bakhsh Hospital

Jeddah, 21452, Saudi Arabia

Location

Dr. Soliman Fakeeh Hospital

Jeddah, 21461, Saudi Arabia

Location

Saudi German Hospital

Jeddah, 21461, Saudi Arabia

Location

Al Abeer Medical Center

Jeddah, 21573, Saudi Arabia

Location

Al-Abeer Medical Center

Jeddah, 21573, Saudi Arabia

Location

Al Abeer Polyclinic

Jeddah, 23531, Saudi Arabia

Location

Al Rahman Polyclinic

Mecca, 24232, Saudi Arabia

Location

Shifa Hospital

Mecca, 24232, Saudi Arabia

Location

Al-Noor Specialist Hospital

Mecca, 24241, Saudi Arabia

Location

Al Zafer Hospital

Najrān, 66261, Saudi Arabia

Location

Obesity, Endocrine and Metabolism Center

Riyadh, 11525, Saudi Arabia

Location

Riyadh Medical Center

Riyadh, 11533, Saudi Arabia

Location

Alalam Medical Center

Riyadh, 13214, Saudi Arabia

Location

Al Hada Armed Forces Hospital

Ta'if, 21944, Saudi Arabia

Location

Prince Fahad bin Sultan hospital

Tabuk, 47311, Saudi Arabia

Location

Al Amal Medical Group

Yanbu, 46455, Saudi Arabia

Location

Alansari Specialist Hospital

Yanbu, 46455, Saudi Arabia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin; Dipeptidyl Peptidase 4

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dipeptidyl-Peptidases and Tripeptidyl-Peptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Ahmed Mansour, +201028866717

  ahmed.mansour@boehringer-ingelheim.com

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 5, 2018
• Study Start: September 26, 2018
• Primary Completion: January 11, 2021
• Study Completion: January 11, 2021
• Last Updated: February 10, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-02

Locations

SA (21)