An observational study in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 21 sites in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-10.
Sponsored by Boehringer Ingelheim · Observational
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
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's enrollment of 1,502 is above the median of 200 across 188 observational studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main diagnosis for study entry
-Patients diagnosed with T2DM will be included.
Exclusion Criteria:
Drug: Empagliflozin · Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors
Drug
Dipeptidyl-peptidase 4 - Drug
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).
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).
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).
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).
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.
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.
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.
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.
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.
| Milestone | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Started | 751 | 751 |
| Completed | 710 | 698 |
| Not completed | 41 | 53 |
| Withdrew: Personal reasons | 3 | 2 |
| Withdrew: Switching therapy | 3 | 3 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 33 | 41 |
| Withdrew: No data as study site was closed | 2 | 6 |
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.
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Number of Participants With Ketoacidosis | 1 | 1 |
Severe UTIs is defined as pyelonephritis or urosepsis.
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Number of Participants With Severe Urinary Tract Infections (UTIs) | 0 | 0 |
Volume depletion is defined as the reduction in the extracellular fluids.
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Number of Participants With Volume Depletion | 6 | 7 |
Dehydration is defined as the loss of total body water that leads to hypertonicity.
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Number of Participants With Dehydration | 0 | 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).
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Ramadan month 2019 | 0 | 0 |
| Ramadan month 2020 | 0 | 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).
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Ramadan month 2019 | 0 | 0 |
| Ramadan month 2020 | 0 | 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).
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Ramadan month 2019 | 0 | 0 |
| Ramadan month 2020 | 0 | 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).
| Participants | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Ramadan month 2019 | 0 | 0 |
| Ramadan month 2020 | 0 | 0 |
Collected over Up to 12 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Empagliflozin | 0/751 (0%) | 6/751 (0.8%) | 0/751 (0%) |
| DPP-4 Inhibitors | 0/751 (0%) | 2/751 (0.3%) | 0/751 (0%) |
| Event | Empagliflozin | DPP-4 Inhibitors |
|---|---|---|
| Myocardial ischaemiaCardiac disorders | 1/751 | 0/751 |
| Anal fissureGastrointestinal disorders | 1/751 | 0/751 |
| HerniaGeneral disorders | 1/751 | 0/751 |
| PneumoniaInfections and infestations | 1/751 | 0/751 |
| Diabetic ketoacidosisMetabolism and nutrition disorders | 1/751 | 1/751 |
| ObesityMetabolism and nutrition disorders | 1/751 | 0/751 |
| Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/751 | 0/751 |
| Acute kidney injuryRenal and urinary disorders | 0/751 | 1/751 |
| End stage renal diseaseRenal and urinary disorders | 0/751 | 1/751 |
Enrolled Set: All patients with type 2 diabetes mellitus included in this study who signed the informed consent.
| Age, Continuous(Years) | Empagliflozin | DPP-4 Inhibitors | Total |
|---|---|---|---|
| Mean | 52.1 ± 10.3 | 52.9 ± 10.7 | 52.5 ± 10.5 |
| Sex: Female, Male(Participants) | Empagliflozin | DPP-4 Inhibitors | Total |
|---|---|---|---|
| Female | 273 | 264 | 537 |
| Male | 478 | 487 | 965 |
| Race and Ethnicity Not Collected(Participants) | Empagliflozin | DPP-4 Inhibitors | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1. find information in order to request access to clinical study data, for listed studies. 2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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