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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
trial testing Empagliflozin in Diabetes Mellitus, Type 2 in 1,502 participants. Completed in 11 January 2021.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,502 |
| Start date | 26 September 2018 |
| Primary completion | 11 January 2021 |
| Estimated completion | 11 January 2021 |
| Sites | 21 locations across Saudi Arabia |
Boehringer Ingelheim — full company profile →
18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 1 | |
| DPP-4 Inhibitors | 1 |
Severe UTIs is defined as pyelonephritis or urosepsis.
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
Volume depletion is defined as the reduction in the extracellular fluids.
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 6 | |
| DPP-4 Inhibitors | 7 |
Dehydration is defined as the loss of total body water that leads to hypertonicity.
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Empagliflozin | 0 | |
| DPP-4 Inhibitors | 0 |
Time frame: Up to 12 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|---|
| Myocardial ischaemia | Cardiac disorders | — | — |
| Anal fissure | Gastrointestinal disorders | — | — |
| Hernia | General disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | — | — |
| Obesity | Metabolism and nutrition disorders | — | — |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| End stage renal disease | Renal and urinary disorders | — | — |
Most-reported serious reactions: Myocardial ischaemia, Anal fissure, Hernia, Pneumonia, Diabetic ketoacidosis, Obesity, Lung adenocarcinoma, Acute kidney injury.
Data from ClinicalTrials.gov NCT03764631 adverse events section.
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
1 peer-reviewed publication reference this trial (live from Europe PMC):
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