Diabetes Mellitus, Type 2NCT03764631
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
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 21 sites in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Empagliflozin and Dipeptidyl-peptidase 4 (DPP-4) inhibitors
- How many people
- 1,502 participants
- Where
- 21 sitesSaudi Arabia
- Study dates
- 26 Sep 2018to 11 Jan 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Main diagnosis for study entry -Patients diagnosed with T2DM will be included.
Who may be able to join
- 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.
Who cannot join
- 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 exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Saudi Arabia21 sites
Abha International Private Hospital
Abhā, 61431
DAFA Special Polyclinic
Jeddah, 21214
Ghassan Najeeb Pharaon Hospital
Jeddah, 21412
International Medical Center
Jeddah, 21451
Dr.Bakhsh Hospital
Jeddah, 21452
Dr. Soliman Fakeeh Hospital
Jeddah, 21461
Saudi German Hospital
Jeddah, 21461
Al Abeer Medical Center
Jeddah, 21573
Al-Abeer Medical Center
Jeddah, 21573
Al Abeer Polyclinic
Jeddah, 23531
Al Rahman Polyclinic
Mecca, 24232
Shifa Hospital
Mecca, 24232
Al-Noor Specialist Hospital
Mecca, 24241
Al Zafer Hospital
Najran, 66261
Obesity, Endocrine and Metabolism Center
Riyadh, 11525
Riyadh Medical Center
Riyadh, 11533
Alalam Medical Center
Riyadh, 13214
Al Hada Armed Forces Hospital
Ta'if, 21944
Prince Fahad bin Sultan hospital
Tabuk, 47311
Al Amal Medical Group
Yanbu, 46455
Alansari Specialist Hospital
Yanbu, 46455
About this study
Official title: Post-authorization Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration Among Patients Treated With Empagliflozin or DPP-4 Inhibitors in Saudi Arabia
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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Empagliflozin, Dipeptidyl-peptidase 4 (DPP-4) inhibitors
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Drug
Dipeptidyl-peptidase 4 (DPP-4) inhibitorsDrug
Dipeptidyl-peptidase 4 - Drug
| Study group | Role | What they receive |
|---|---|---|
| subjects with Type 2 Diabetes mellitus | Not described Receives: Drug: Empagliflozin; Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Up to day 29.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start26 Sep 2018
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Mansour, +201028866717, Study chair, ahmed.mansour@boehringer-ingelheim.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764631
- Sponsor's protocol ID
- 1245-0149
- Status last verified
- Feb 2022
- First submitted
- 26 Nov 2018
- Last updated
- 10 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-authorization Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration Among Patients Treated With Empagliflozin or DPP-4 Inhibitors in Saudi Arabia
- ClinicalTrials.gov ID
- NCT03764631
- Acronym / sponsor ID
- 1245-0149
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Posted 10 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with Type 2 Diabetes mellitus | – | Drug: Empagliflozin, Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Main diagnosis for study entry -Patients diagnosed with T2DM will be included.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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 exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinDrug | Drug | subjects with Type 2 Diabetes mellitus |
| Dipeptidyl-peptidase 4 (DPP-4) inhibitorsDipeptidyl-peptidase 4 - Drug | Drug | subjects with Type 2 Diabetes mellitus |
Primary outcome
Number of Participants With Ketoacidosis
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).
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)
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).
Severe UTIs is defined as pyelonephritis or urosepsis.
Number of Participants With Volume Depletion
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).
Volume depletion is defined as the reduction in the extracellular fluids.
Number of Participants With Dehydration
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).
Dehydration is defined as the loss of total body water that leads to hypertonicity.
4 secondary outcomes
Number of Participants With Ketoacidosis During Ramadan Periods
Time frame: Up to day 29.
Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods
Time frame: Up to day 29.
Number of Participants With Volume Depletion During Ramadan Periods
Time frame: Up to day 29.
Number of Participants With Dehydration During Ramadan Periods
Time frame: Up to day 29.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mansour, +201028866717 study chair
ahmed.mansour@boehringer-ingelheim.com
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 21 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Ketoacidosis (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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.