Trial · NCT03764631
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, Boehringer Ingelheim; results first posted 2022-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03764631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03764631
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT03764631
- Status
- Completed
- Enrollment
- 1,502 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Empagliflozin, Dipeptidyl-peptidase 4 (DPP-4) inhibitors
- First posted
- 2018-12-05
- Last updated
- 2022-02-10
- Results first posted
- 2022-02-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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). | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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). | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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). | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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). | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Ketoacidosis During Ramadan Periods | Up to day 29. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods | Up to day 29. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Volume Depletion During Ramadan Periods | Up to day 29. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Dehydration During Ramadan Periods | Up to day 29. | Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Ketoacidosis | Empagliflozin | 1 | Participants | ||
| Number of Participants With Ketoacidosis | DPP-4 Inhibitors | 1 | Participants | ||
| Number of Participants With Severe Urinary Tract Infections (UTIs) | Empagliflozin | 0 | Participants | ||
| Number of Participants With Severe Urinary Tract Infections (UTIs) | DPP-4 Inhibitors | 0 | Participants | ||
| Number of Participants With Volume Depletion | Empagliflozin | 6 | Participants | ||
| Number of Participants With Volume Depletion | DPP-4 Inhibitors | 7 | Participants | ||
| Number of Participants With Dehydration | Empagliflozin | 0 | Participants | ||
| Number of Participants With Dehydration | DPP-4 Inhibitors | 0 | Participants | ||
| Number of Participants With Ketoacidosis During Ramadan Periods | Empagliflozin | Ramadan month 2019 | 0 | Participants | |
| Number of Participants With Ketoacidosis During Ramadan Periods | DPP-4 Inhibitors | Ramadan month 2019 | 0 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Empagliflozin | 751 | |
| Overall Study | STARTED | DPP-4 Inhibitors | 751 | |
| Overall Study | COMPLETED | Empagliflozin | 710 | |
| Overall Study | COMPLETED | DPP-4 Inhibitors | 698 | |
| Overall Study | NOT COMPLETED | Empagliflozin | 41 | |
| Overall Study | NOT COMPLETED | DPP-4 Inhibitors | 53 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Myocardial ischaemia | Cardiac disorders | Empagliflozin | 1 | 751 | |
| serious | Myocardial ischaemia | Cardiac disorders | DPP-4 Inhibitors | 0 | 751 | |
| serious | Anal fissure | Gastrointestinal disorders | Empagliflozin | 1 | 751 | |
| serious | Anal fissure | Gastrointestinal disorders | DPP-4 Inhibitors | 0 | 751 | |
| serious | Hernia | General disorders | Empagliflozin | 1 | 751 | |
| serious | Hernia | General disorders | DPP-4 Inhibitors | 0 | 751 | |
| serious | Pneumonia | Infections and infestations | Empagliflozin | 1 | 751 | |
| serious | Pneumonia | Infections and infestations | DPP-4 Inhibitors | 0 | 751 | |
| serious | Diabetic ketoacidosis | Metabolism and nutrition disorders | Empagliflozin | 1 | 751 | |
| serious | Diabetic ketoacidosis | Metabolism and nutrition disorders | DPP-4 Inhibitors | 1 | 751 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Empagliflozin | 0 | 751 |
| Total, all-cause mortality | DPP-4 Inhibitors | 0 | 751 |
| Total, other adverse events | Empagliflozin | 0 | 751 |
| Total, other adverse events | DPP-4 Inhibitors | 0 | 751 |
| Total, serious adverse events | Empagliflozin | 6 | 751 |
| Total, serious adverse events | DPP-4 Inhibitors | 2 | 751 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Empagliflozin vs DPP-4 Inhibitors: Number of Participants With Ketoacidosis | Trial comparisons |
| Empagliflozin vs DPP-4 Inhibitors: Number of Participants With Volume Depletion | Trial comparisons |
| Empagliflozin vs DPP-4 Inhibitors: Number of Participants With Dehydration | Trial comparisons |
| Empagliflozin vs DPP-4 Inhibitors: Number of Participants With Severe Urinary Tract Infections (UTIs) | Trial comparisons |
| Empagliflozin vs DPP-4 Inhibitors: deaths from any cause | Trial comparisons |
| Empagliflozin vs DPP-4 Inhibitors: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03764631
GET https://conductscience.org/api/trials/v1/NCT03764631/results?page=2