Diabetes Mellitus, Type 2
Conditions
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
Interventions
DRUGEmpagliflozin
Drug
DRUGDipeptidyl-peptidase 4 (DPP-4) inhibitors
Dipeptidyl-peptidase 4 - Drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dehydration | 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). | Dehydration is defined as the loss of total body water that leads to hypertonicity. |
| Number of Participants With Ketoacidosis | 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). | 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. |
| Number of Participants With Severe Urinary Tract Infections (UTIs) | 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). | Severe UTIs is defined as pyelonephritis or urosepsis. |
| Number of Participants With Volume Depletion | 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). | Volume depletion is defined as the reduction in the extracellular fluids. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ketoacidosis During Ramadan Periods | Up to day 29. | 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). |
| Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods | Up to day 29. | 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). |
| Number of Participants With Volume Depletion During Ramadan Periods | Up to day 29. | 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). |
| Number of Participants With Dehydration During Ramadan Periods | Up to day 29. | 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). |
Countries
Saudi Arabia
Participant flow
Recruitment details
A non-interventional study with new data collection from patients with type 2 diabetes mellitus in Saudi Arabia. The study used a new users design and compared new users of Empagliflozin to new users of Dipeptidyl peptidase-4 (DPP-4) inhibitors.
Pre-assignment details
Only patients who met all of the inclusion and none of the exclusion criteria were enrolled into the study after signing the informed consent form.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 751 |
| 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. | 751 |
| Total | 1,502 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 33 | 41 |
| Overall Study | No data as study site was closed | 2 | 6 |
| Overall Study | Personal Reasons | 3 | 2 |
| Overall Study | Switching Therapy | 3 | 3 |
Baseline characteristics
| Characteristic | Empagliflozin | DPP-4 Inhibitors | Total |
|---|---|---|---|
| Age, Continuous | 52.1 Years STANDARD_DEVIATION 10.3 | 52.9 Years STANDARD_DEVIATION 10.7 | 52.5 Years STANDARD_DEVIATION 10.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 273 Participants | 264 Participants | 537 Participants |
| Sex: Female, Male Male | 478 Participants | 487 Participants | 965 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 751 | 0 / 751 |
| other Total, other adverse events | 0 / 751 | 0 / 751 |
| serious Total, serious adverse events | 6 / 751 | 2 / 751 |
Outcome results
Primary
Number of Participants With Dehydration
Dehydration is defined as the loss of total body water that leads to hypertonicity.
Time frame: 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).
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empagliflozin | Number of Participants With Dehydration | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Dehydration | 0 Participants |
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.
Time frame: 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).
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empagliflozin | Number of Participants With Ketoacidosis | 1 Participants |
| DPP-4 Inhibitors | Number of Participants With Ketoacidosis | 1 Participants |
Primary
Number of Participants With Severe Urinary Tract Infections (UTIs)
Severe UTIs is defined as pyelonephritis or urosepsis.
Time frame: 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).
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empagliflozin | Number of Participants With Severe Urinary Tract Infections (UTIs) | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Severe Urinary Tract Infections (UTIs) | 0 Participants |
Primary
Number of Participants With Volume Depletion
Volume depletion is defined as the reduction in the extracellular fluids.
Time frame: 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).
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Empagliflozin | Number of Participants With Volume Depletion | 6 Participants |
| DPP-4 Inhibitors | Number of Participants With Volume Depletion | 7 Participants |
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).
Time frame: Up to day 29.
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Number of Participants With Dehydration During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| Empagliflozin | Number of Participants With Dehydration During Ramadan Periods | Ramadan month 2020 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Dehydration During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Dehydration During Ramadan Periods | Ramadan month 2020 | 0 Participants |
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).
Time frame: Up to day 29.
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Number of Participants With Ketoacidosis During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| Empagliflozin | Number of Participants With Ketoacidosis During Ramadan Periods | Ramadan month 2020 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Ketoacidosis During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Ketoacidosis During Ramadan Periods | Ramadan month 2020 | 0 Participants |
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).
Time frame: Up to day 29.
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| Empagliflozin | Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods | Ramadan month 2020 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods | Ramadan month 2020 | 0 Participants |
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).
Time frame: Up to day 29.
Population: Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Empagliflozin | Number of Participants With Volume Depletion During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| Empagliflozin | Number of Participants With Volume Depletion During Ramadan Periods | Ramadan month 2020 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Volume Depletion During Ramadan Periods | Ramadan month 2019 | 0 Participants |
| DPP-4 Inhibitors | Number of Participants With Volume Depletion During Ramadan Periods | Ramadan month 2020 | 0 Participants |