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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03764631
• Collaborator: (none)
• Enrollment: 1,502
• Locations: 21
• Actual Duration (Months): 27.5
• Patients Per Site: 71.5
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Empagliflozin; Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors

Study Design

• Study Type: Observational
• Actual Enrollment: 1502 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Sep 26, 2018
• Actual Primary Completion Date: Jan 11, 2021
• Actual Study Completion Date: Jan 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
subjects with Type 2 Diabetes mellitus	Drug: Empagliflozin; Drug; Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors; Dipeptidyl-peptidase 4 - Drug

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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 Outcome Measures

1. 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).

2. 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).

3. 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).

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abha International Private Hospital	Abha		Saudi Arabia	61431
2	DAFA Special Polyclinic	Jeddah		Saudi Arabia	21214
3	Ghassan Najeeb Pharaon Hospital	Jeddah		Saudi Arabia	21412
4	International Medical Center	Jeddah		Saudi Arabia	21451
5	Dr.Bakhsh Hospital	Jeddah		Saudi Arabia	21452
6	Dr. Soliman Fakeeh Hospital	Jeddah		Saudi Arabia	21461
7	Saudi German Hospital	Jeddah		Saudi Arabia	21461
8	Al Abeer Medical Center	Jeddah		Saudi Arabia	21573
9	Al-Abeer Medical Center	Jeddah		Saudi Arabia	21573
10	Al Abeer Polyclinic	Jeddah		Saudi Arabia	23531
11	Al Rahman Polyclinic	Makkah		Saudi Arabia	24232
12	Shifa Hospital	Makkah		Saudi Arabia	24232
13	Al-Noor Specialist Hospital	Makkah		Saudi Arabia	24241
14	Al Zafer Hospital	Najran		Saudi Arabia	66261
15	Obesity, Endocrine and Metabolism Center	Riyadh		Saudi Arabia	11525
16	Riyadh Medical Center	Riyadh		Saudi Arabia	11533
17	Alalam Medical Center	Riyadh		Saudi Arabia	13214
18	Prince Fahad bin Sultan hospital	Tabuk		Saudi Arabia	47311
19	Al Hada Armed Forces Hospital	Taif		Saudi Arabia	21944
20	Al Amal Medical Group	Yanbu		Saudi Arabia	46455
21	Alansari Specialist Hospital	Yanbu		Saudi Arabia	46455

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Ahmed Mansour, [phone], [e-mail]

Study Documents (Full-Text)

• Study Protocol - Sep 23, 2019
• Statistical Analysis Plan - Apr 17, 2019

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT03764631
• Other Study ID Numbers: 1245-0149
• First Posted: Dec 5, 2018
• Last Update Posted: Feb 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Urinary Tract Infections; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dehydration; Ketosis; Hypovolemia; Empagliflozin; Dipeptidyl-Peptidase IV Inhibitors

Study Results

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 Detail	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.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	751	751
COMPLETED	710	698
NOT COMPLETED	41	53

Baseline Characteristics

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	751	751	1502
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	52.1 (10.3)	52.9 (10.7)	52.5 (10.5)
Sex: Female, Male (Count of Participants)
Female	273 36.4%	264 35.2%	537 35.8%
Male	478 63.6%	487 64.8%	965 64.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Ketoacidosis
Description	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).

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Count of Participants [Participants]	1 0.1%	1 0.1%

2. Primary Outcome

Title	Number of Participants With Severe Urinary Tract Infections (UTIs)
Description	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).

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Count of Participants [Participants]	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants With Volume Depletion
Description	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).

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Count of Participants [Participants]	6 0.8%	7 0.9%

4. Primary Outcome

Title	Number of Participants With Dehydration
Description	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).

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Ketoacidosis During Ramadan Periods
Description	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.

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Ramadan month 2019	0 0%	0 0%
Ramadan month 2020	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods
Description	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.

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Ramadan month 2019	0 0%	0 0%
Ramadan month 2020	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants With Volume Depletion During Ramadan Periods
Description	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.

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Ramadan month 2019	0 0%	0 0%
Ramadan month 2020	0 0%	0 0%

8. Secondary Outcome

Title	Number of Participants With Dehydration During Ramadan Periods
Description	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.

Outcome Measure Data

Analysis Population Description

Enrolled Set: All patients with type 2 diabetes mellitus included in the study who signed the informed consent.

Arm/Group Title	Empagliflozin	DPP-4 Inhibitors
Arm/Group Description	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.	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.
Measure Participants	751	751
Ramadan month 2019	0 0%	0 0%
Ramadan month 2020	0 0%	0 0%

Adverse Events

Time Frame	Up to 12 months.
Adverse Event Reporting Description	Enrolled Set: All patients with type 2 diabetes mellitus included in this study who signed the informed consent.
Arm/Group Title	Empagliflozin		DPP-4 Inhibitors
Arm/Group Description	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.		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.
All Cause Mortality
	Empagliflozin		DPP-4 Inhibitors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/751 (0%)		0/751 (0%)
Serious Adverse Events
	Empagliflozin		DPP-4 Inhibitors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/751 (0.8%)		2/751 (0.3%)
Cardiac disorders
Myocardial ischaemia	1/751 (0.1%)		0/751 (0%)
Gastrointestinal disorders
Anal fissure	1/751 (0.1%)		0/751 (0%)
General disorders
Hernia	1/751 (0.1%)		0/751 (0%)
Infections and infestations
Pneumonia	1/751 (0.1%)		0/751 (0%)
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/751 (0.1%)		1/751 (0.1%)
Obesity	1/751 (0.1%)		0/751 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma	1/751 (0.1%)		0/751 (0%)
Renal and urinary disorders
Acute kidney injury	0/751 (0%)		1/751 (0.1%)
End stage renal disease	0/751 (0%)		1/751 (0.1%)
Other (Not Including Serious) Adverse Events
	Empagliflozin		DPP-4 Inhibitors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/751 (0%)		0/751 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.