| 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. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Posted | | Count of Participants | | Participants | | 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). | | | | ID | Title | Description |
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| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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| Primary | Number of Participants With Severe Urinary Tract Infections (UTIs) | Severe UTIs is defined as pyelonephritis or urosepsis. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Posted | | Count of Participants | | Participants | | 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). | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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| Primary | Number of Participants With Volume Depletion | Volume depletion is defined as the reduction in the extracellular fluids. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent. | Posted | | Count of Participants | | Participants | | 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). | | | | ID | Title | Description |
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| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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| Primary | Number of Participants With Dehydration | Dehydration is defined as the loss of total body water that leads to hypertonicity. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent. | Posted | | Count of Participants | | Participants | | 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). | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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| 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).
| Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Posted | | Count of Participants | | Participants | | Up to day 29. | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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| 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).
| Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Posted | | Count of Participants | | Participants | | Up to day 29. | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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| 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).
| Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Posted | | Count of Participants | | Participants | | Up to day 29. | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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| 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).
| Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Posted | | Count of Participants | | Participants | | Up to day 29. | | | | ID | Title | Description |
|---|
| OG000 | Empagliflozin | Patients with type 2 diabetes mellitus (T2DM) and newly using Empagliflozin (e.g. Patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or Dipeptidyl peptidase-4 (DPP-4) inhibitors during the previous 12 months). Empagliflozin was administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. | | OG001 | DPP-4 Inhibitors | Patients with type 2 diabetes mellitus (T2DM) and newly using Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. patients had not used other Sodium/Glucose co-transporter 2 (SLGT2) or DPP-4 inhibitors during the previous 12 months). DPP-4 inhibitors were administered according to the approved labels in Saudi Arabia. Patients were followed up for 12 months after the index date. |
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