JARDIANCE Regulartory Post Marketing Surveillance in Korean Type 2 Diabetes Mellitus

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02848833
• Collaborator: (none)
• Enrollment: 3,368
• Location: 1
• Actual Duration (Months): 44.2
• Patients Per Site Per Month: 76.2

Study Details

Study Description

Brief Summary

To monitor the safety profile and effectiveness of Empagliflozin in Korea patients with type 2 diabetes mellitus in a routine clinical practice setting

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: JARDIANCE 10mg; Drug: JARDIANCE 25mg

Study Design

• Study Type: Observational
• Actual Enrollment: 3368 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Regulatory Requirement Non Interventional Study to Monitor the Safety and Effectiveness of JARDIANCE® (Empagliflozin, 10mg, 25mg, q.d.) in Korean Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Aug 10, 2016
• Actual Primary Completion Date: Apr 17, 2020
• Actual Study Completion Date: Apr 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
JARDIANCE T2DM with JARDIANCE	Drug: JARDIANCE 10mg; T2DM with JARDIANCE 10mg; Drug: JARDIANCE 25mg; MT2DM with JARDIANCE 25mgax

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Any Adverse Events [From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.]

   Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

2. Percentage of Participants With Adverse Events Relating to Study Drug [From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.]

   Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

3. Percentage of Participants With Unexpected Adverse Events [From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.]

   Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

4. Percentage of Participants With Adverse Events of Special Interest [From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.]

   Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Increased urination Urinary tract infection (UTI) Volume depletion Diabetic Ketoacidosis (DKA) Decreased renal function: Hepatic injury Lower limb amputation

5. Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug [From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.]

   Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.

Secondary Outcome Measures

1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit [At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.

2. Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit [At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.

3. Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit [At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit

4. Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit [At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Change from baseline in fasting plasma glucose (FPG) at last visit.

5. Change From Baseline in Body Weight at Last Visit [At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Change from baseline in body weight at last visit.

6. Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit [At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Change from baseline in systolic blood pressure (SBP) at last visit.

7. Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit [At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Change from baseline in diastolic blood pressure (DBP) at last visit.

8. Number of Participants Per Final Effectiveness Assessment Category at Last Visit [At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).]

   Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Patients who have been started on JARDIANCE® in accordance with the approved label in Korea

2. Age = 19 years at enrolment

3. Patients who have signed on the data release consent form

Exclusion criteria:

1. Known hypersensitivity to empagliflozin or any of its excipients

2. Patients with type 1 diabetes or for the treatment of diabetic ketoacidosis

3. Patients with persistent estimated Glomerular Filtration Rate <60 mL/min/1.73 m2,end stage renal disease or on dialysis

4. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

5. Patients for whom empagliflozin is contraindicated according local label of JARDIANCE®

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Multiple Locations		Korea, Republic of

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 23, 2017

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02848833
• Other Study ID Numbers: 1245.116
• First Posted: Jul 29, 2016
• Last Update Posted: May 11, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Empagliflozin

Study Results

Participant Flow

Recruitment Details	This was and observational prospective, non-interventional, open-label, multi-centre study to monitor the safety profile and efficacy of JARDIANCE® (empagliflozin, 10 milligram (mg), 25mg) in Korean patients with type 2 diabetes mellitus in a routine clinical practice setting.
Pre-assignment Detail	All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Period Title: Overall Study
STARTED	3368
COMPLETED	3231
NOT COMPLETED	137

Baseline Characteristics

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Overall Participants	3231
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.66 (11.60)
Sex: Female, Male (Count of Participants)
Female	1380 42.7%
Male	1851 57.3%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Any Adverse Events
Description	Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time Frame	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description

Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	3231
Number (95% Confidence Interval) [Percentage of participants]	13.93 0.4%

2. Primary Outcome

Title	Percentage of Participants With Adverse Events Relating to Study Drug
Description	Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time Frame	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description

Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	3231
Number (95% Confidence Interval) [Percentage of participants]	5.14 0.2%

3. Primary Outcome

Title	Percentage of Participants With Unexpected Adverse Events
Description	Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time Frame	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description

Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	3231
Number (95% Confidence Interval) [Percentage of participants]	11.54 0.4%

4. Primary Outcome

Title	Percentage of Participants With Adverse Events of Special Interest
Description	Percentage of participants with adverse events of special interest (AESI) was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method. The following are considered as AESIs: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Increased urination Urinary tract infection (UTI) Volume depletion Diabetic Ketoacidosis (DKA) Decreased renal function: Hepatic injury Lower limb amputation
Time Frame	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description

Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	3231
Number (95% Confidence Interval) [Percentage of participants]	1.45 0%

5. Primary Outcome

Title	Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug
Description	Percentage of participants with adverse events leading to discontinuation of the drug was reported. The 95% Confidence Interval for the percentage of participants with adverse events was calculated by Exact Method.
Time Frame	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.

Outcome Measure Data

Analysis Population Description

Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	3231
Number (95% Confidence Interval) [Percentage of participants]	3.25 0.1%

6. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Last Visit
Description	Change from baseline in glycosylated hemoglobin (HbA1c) at last visit.
Time Frame	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2567
Mean (Standard Deviation) [Percentage of glycosylated hemoglobin]	-0.68 (1.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JARDIANCE®
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Difference before administration versus after administration was analyzed using a paired t-test.
	Method	paired t-test
	Comments

7. Secondary Outcome

Title	Number of Patients Who Had Glycosylated Hemoglobin (HbA1c) Reaching Less Than 7% (Target Efficacy Response Rate) at the Last Visit
Description	Number of patients who had glycosylated hemoglobin (HbA1c) reaching less than 7% (target efficacy response rate) at the last visit.
Time Frame	At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2567
lower than 7%	1132 35%
greater than or equal to 7%	1435 44.4%

8. Secondary Outcome

Title	Number of Patients With Relative Effectiveness Response in Glycosylated Hemoglobin (HbA1c) (Decrease by at Least 0.5% Comparing to Baseline) at the Last Visit
Description	Number of patients with relative effectiveness response in glycosylated hemoglobin (HbA1c) (decrease by at least 0.5% comparing to baseline) at the last visit
Time Frame	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2567
greater than or equal to 0.5%	1315 40.7%
lower than 0.5%	1252 38.7%

9. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG) at Last Visit
Description	Change from baseline in fasting plasma glucose (FPG) at last visit.
Time Frame	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2160
Mean (Standard Deviation) [milligram per deciliter (mg/dl)]	-25.59 (59.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JARDIANCE®
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Difference before administration versus after administration was analyzed using a paired t-test.
	Method	paired t-test
	Comments

10. Secondary Outcome

Title	Change From Baseline in Body Weight at Last Visit
Description	Change from baseline in body weight at last visit.
Time Frame	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2097
Mean (Standard Deviation) [kilogram]	-1.91 (3.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JARDIANCE®
	Comments
	Type of Statistical Test	Other
	Comments	Difference before administration versus after administration was analyzed using a paired t-test.
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	paired t-test
	Comments

11. Secondary Outcome

Title	Change From Baseline in Systolic Blood Pressure (SBP) at Last Visit
Description	Change from baseline in systolic blood pressure (SBP) at last visit.
Time Frame	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2355
Mean (Standard Deviation) [millimeters of mercury (mmHg)]	-3.95 (15.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JARDIANCE®
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Difference before administration versus after administration was analyzed using a paired t-test.
	Method	paired t-test
	Comments

12. Secondary Outcome

Title	Change From Baseline in Diastolic Blood Pressure (DBP) at Last Visit
Description	Change from baseline in diastolic blood pressure (DBP) at last visit.
Time Frame	At baseline (Visit 1) and at the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy. Only those subjects with non-missing outcome measures were included in this analysis.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2354
Mean (Standard Deviation) [millimeters of mercury (mmHg)]	-1.80 (10.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	JARDIANCE®
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Difference before administration versus after administration was analyzed using a paired t-test.
	Method	paired t-test
	Comments

13. Secondary Outcome

Title	Number of Participants Per Final Effectiveness Assessment Category at Last Visit
Description	Number of participants per final effectiveness assessment category at last visit was reported. The final effeciveness consisted of 4 categories: Improved (If determined as there was any effect of maintaining or improving disease related factors.), Unchanged (If disease related factors had not been changed compared with before administration, and not determined as there was any effect of maintaining symptoms.), Aggravated (If disease related factors were worse than before administration.), and Unassessable (If it cannot be determined due to insufficient information collected.).
Time Frame	At the last visit (the last follow-up visit a patient actually attended during the study, up to day 544).

Outcome Measure Data

Analysis Population Description

Effectiveness analysis set: All Participants who signed the informed consent form to participate in this study as subject, visited as per the study schedule, took JARDIANCE®, and were evaluated for the efficacy.

Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
Measure Participants	2567
Improved	1749 54.1%
Unchanged	546 16.9%
Aggravated	195 6%
Unassessable	77 2.4%

Adverse Events

Time Frame	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 544 days.
Adverse Event Reporting Description	Safety analysis set: All Participants who signed the informed consent form to participate in this study as subject, took JARDIANCE® once at least, and were followed up by the physician once or more.
Arm/Group Title	JARDIANCE®
Arm/Group Description	JARDIANCE® was prescribed according to the local label and at the discretion of the treating physician. The recommended dose of JARDIANCE® was 10 milligram (mg) once daily. In patients tolerating JARDIANCE® 10 mg once daily and requiring additional glycemic control, the dose could be increased to 25 mg once daily. When JARDIANCE® was used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin was considered to reduce the risk of hypoglycaemia. JARDIANCE® could be taken with or without food and tablets and was swallowed whole. If a dose was missed, it was taken as soon as the patient remembered. A double dose was not taken on the same day.
All Cause Mortality
	JARDIANCE®
	Affected / at Risk (%)	# Events
Total	0/3231 (0%)
Serious Adverse Events
	JARDIANCE®
	Affected / at Risk (%)	# Events
Total	55/3231 (1.7%)
Cardiac disorders
Angina pectoris	1/3231 (0%)
Angina unstable	4/3231 (0.1%)
Coronary artery disease	1/3231 (0%)
Prinzmetal angina	2/3231 (0.1%)
Eye disorders
Glaucoma	1/3231 (0%)
Pathologic myopia	1/3231 (0%)
Retinal detachment	1/3231 (0%)
Retinal vein occlusion	1/3231 (0%)
Rhegmatogenous retinal detachment	1/3231 (0%)
Gastrointestinal disorders
Colitis	1/3231 (0%)
Colitis ischaemic	1/3231 (0%)
Diarrhoea	1/3231 (0%)
Gastric ulcer	1/3231 (0%)
Large intestinal haemorrhage	1/3231 (0%)
Nausea	1/3231 (0%)
Vomiting	1/3231 (0%)
General disorders
Pyrexia	1/3231 (0%)
Vascular stent stenosis	1/3231 (0%)
Vascular stent thrombosis	1/3231 (0%)
Hepatobiliary disorders
Autoimmune hepatitis	1/3231 (0%)
Cholecystitis acute	1/3231 (0%)
Cholelithiasis	1/3231 (0%)
Infections and infestations
Appendiceal abscess	1/3231 (0%)
Appendicitis	1/3231 (0%)
Cellulitis	1/3231 (0%)
Meningitis	1/3231 (0%)
Otitis media chronic	1/3231 (0%)
Peritonsillar abscess	1/3231 (0%)
Pneumonia	1/3231 (0%)
Pulmonary tuberculosis	1/3231 (0%)
Pyelonephritis acute	1/3231 (0%)
Sepsis	1/3231 (0%)
Subcutaneous abscess	1/3231 (0%)
Tubo-ovarian abscess	1/3231 (0%)
Vestibular neuronitis	1/3231 (0%)
Injury, poisoning and procedural complications
Limb injury	1/3231 (0%)
Road traffic accident	1/3231 (0%)
Splenic injury	1/3231 (0%)
Sternal fracture	1/3231 (0%)
Investigations
Alanine aminotransferase increased	1/3231 (0%)
Aspartate aminotransferase increased	1/3231 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	1/3231 (0%)
Hyperglycaemia	3/3231 (0.1%)
Hyponatraemia	1/3231 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/3231 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of ampulla of Vater	1/3231 (0%)
Benign ovarian tumour	1/3231 (0%)
Bladder cancer	1/3231 (0%)
Gastric cancer	1/3231 (0%)
Pancreatic carcinoma	1/3231 (0%)
Rectal cancer	1/3231 (0%)
Thyroid cancer	1/3231 (0%)
Uterine leiomyoma	1/3231 (0%)
Nervous system disorders
Cerebral infarction	1/3231 (0%)
Headache	1/3231 (0%)
Intracranial aneurysm	1/3231 (0%)
Renal and urinary disorders
Acute kidney injury	1/3231 (0%)
Ureterolithiasis	1/3231 (0%)
Reproductive system and breast disorders
Cervix inflammation	1/3231 (0%)
Skin and subcutaneous tissue disorders
Diabetic foot	1/3231 (0%)
Vascular disorders
Deep vein thrombosis	1/3231 (0%)
Other (Not Including Serious) Adverse Events
	JARDIANCE®
	Affected / at Risk (%)	# Events
Total	0/3231 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.