Regulatory Request NIS in Korea | NCT03642717

Status Module

Label	Type	Description	Intervention Names
Subjects diagnosed with type 2 diabetes mellitus			Drug: JARDIANCE DUO®

Name	Type	Description	Arm Group Labels	Other Names
JARDIANCE DUO®	Drug	empagliflozin and metformin	Subjects diagnosed with type 2 diabetes mellitus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Any Adverse Events	Percentage of participants with any adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Percentage of Participants With Adverse Events Relating to Study Drug	Percentage of participants with adverse events relating to study drug was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Percentage of Participants With Unexpected Adverse Events	Percentage of participants with unexpected adverse events was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Percentage of Participants With Adverse Events of Special Interest	Percentage of participants with adverse events of special interest was reported. The 95% Confidence Interval for the percentage of participants with adverse event was calculated by Exact Method.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.
Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug	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 event was calculated by Exact Method.

Secondary Outcomes

Measure	Description	Time Frame
Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline	Change in the glycosylated hemoglobin (HbA1c) at Last Visit from baseline was reported.	At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have started at first time on JARDIANCE DUO® in accordance with the approved label in Korea
Age ≥19 years at enrolment
Patients who have signed on the data release consent form

Exclusion Criteria:

Patients with previous exposure to JARDIANCE®, JARDIANCE DUO®
Hypersensitivity to active ingredients empagliflozin and/or metformin or to any of the excipients
Moderate (stage 3b) and severe renal failure (CrCl < 45 ml/min or eGFR < 45 ml/min/1.73 square meter)
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, cardiovascular collapse (shock), acute myocardial infarction, sepsis
Type1 diabetes, acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma, history of a ketoacidosis (type 1 diabetes and diabetic ketoacidosis should be treated with insulin).
Congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure
Radiologic studies involving the use of intravascular iodinated contrast materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials)
Intravascular administration of iodinated contrast media may lead to acute renal failure and has been associated with lactic acidosis in patients receiving metformin.

Therefore, in patients with eGFR > 60ml/min/1.73m2, JARDIANCE DUO® must be discontinued prior to, or at the time of the test and not be reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further. In patients with moderate renal impairment (eGFR 45-60 ml/min/1.73m2), JARDIANCE DUO® must be discontinued 48 hours before administration of iodinated contrast media and not be reinstituted until at least 48 hours afterwards, and only after renal function has been re-evaluated and has not deteriorated further.

In patients with severe infections or severe traumatic systemic disorders, JARDIANCE DUO® should be temporarily suspended, and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal.
JARDIANCE DUO® should be temporarily suspended for any surgical procedure(except minor procedures not associated with restricted intake of food and fluids)before 48 hours, and not be reinstituted until 48 hours afterwards, after renal function has been evaluated as normal.
Patients with malnutrition, starvation, hypostheniam pituitary or adrenal insufficiency
Impaired hepatic function (since impaired hepatic function has been associated with some cases of lactic acidosis, JARDIANCE DUO® should generally be avoided in patients with clinical or laboratory evidence of hepatic disease), pulmonary infarction, severe respiratory impairment, any condition associated with hypoxemia, excessive alcohol intake, GI disorders such as dehydration, diarrhoea or vomiting
Pregnant women, women who may be pregnant, nursing women
Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock
Current participation in other clinical trials

Name	Affiliation	Role
Jane(JiEun) Lee, 8227090092	jane.lee.ext@boehringer-ingelheim.com	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Korea University Ansan Hospital		Ansan		15355	South Korea
Hyewon Medical Foundation Sejong Hospital

Label	URL
Related Info	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 31, 2019	Mar 24, 2021

ID	Title	Description
BG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Any Adverse Events

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

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

Posted

Number

95% Confidence Interval

Percentage of participants

From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).

Units	Counts
Participants	OG000620

Title

Denominators

Categories

Title	Measurements
	OG00011.94(9.49 to 14.75)

Primary

Percentage of Participants With Adverse Events Relating to Study Drug

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

Posted

Number

95% Confidence Interval

Percentage of participants

From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts

Primary

Percentage of Participants With Unexpected Adverse Events

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

Posted

Number

95% Confidence Interval

Percentage of participants

From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts

Primary

Percentage of Participants With Adverse Events of Special Interest

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

Posted

Number

95% Confidence Interval

Percentage of participants

From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts

Primary

Percentage of Participants With Adverse Events Leading to Discontinuation of the Drug

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 event was calculated by Exact Method.

Posted

Number

95% Confidence Interval

Percentage of participants

From baseline (Visit 1) until last visit (the last follow-up visit a patient actually received during the study), up to 349 days.

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units

Secondary

Change in the Glycosylated Hemoglobin (HbA1c) at Last Visit From Baseline

Change in the glycosylated hemoglobin (HbA1c) at Last Visit from baseline was reported.

Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.

Posted

Mean

Standard Deviation

Percentage of glycosylated hemoglobin

At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts
Participants

Secondary

Number of Participants Reached Target Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit

Number of participants reached target effectiveness response in the glycosylated hemoglobin (HbA1c) (HbA1c < 7%) at Last Visit was reported. Target effectiveness response in the glycosylated hemoglobin (HbA1c) was defined as HbA1c less than 7%.

Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.

Posted

Count of Participants

Participants

At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Secondary

Number of Participants With Relative Effectiveness Response in the Glycosylated Hemoglobin (HbA1c) (HbA1c Decrease of 0.5% Comparing to Baseline) at Last Visit

Number of participants with relative effectiveness response in the glycosylated hemoglobin (HbA1c) at Last Visit was reported. Relative effectiveness response in the glycosylated hemoglobin (HbA1c) at last visit was defined as HbA1c decrease of 0.5% or more at the last visit comparing to baseline.

Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.

Posted

Count of Participants

Participants

At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Secondary

Change in the Fasting Plasma Glucose (FPG) at Last Visit From Baseline

Change in the Fasting Plasma Glucose (FPG) at Last Visit from baseline was reported.

Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness. Only those subjects with non-missing outcome measures were included in this analysis.

Posted

Mean

Standard Deviation

milligrams per deciliter (mg/dl)

At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts

Secondary

Change in the Body Weight at Last Visit From Baseline

Change in the body weight at Last Visit from baseline was reported.

Posted

Mean

Standard Deviation

kilogram (kg)

At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts
Participants

Secondary

Change in the Systolic Blood Pressure (SBP) at Last Visit From Baseline

Change in the systolic blood pressure (SBP) at Last Visit from baseline was reported.

Posted

Mean

Standard Deviation

millimetre of mercury (mmHg)

At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts

Secondary

Change in the Diastolic Blood Pressure (DBP) at Last Visit From Baseline

Change in the diastolic blood pressure (DBP) at Last Visit from baseline was reported.

Posted

Mean

Standard Deviation

millimetre of mercury (mmHg)

At baseline (Visit 1) and at last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was visited once at baseline (Visit 1), followed by 1 follow-up visit at 12 weeks after baseline (after 12 weeks of treatment), and the last visit of the study at 24 weeks after baseline (after 24 weeks of treatment).

Units	Counts

Secondary

Number of Participants Per Final Effectiveness Assessment Category at Last Visit

Number of participants per final effectiveness assessment category at Last Visit was reported. The final effectiveness 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.).

Effective analysis set: this set included those who signed the informed consent form to participate in this study as subject, took Jardiance Duo®, and were evaluated for the effectiveness.

Posted

Count of Participants

Participants

At last visit (the last follow-up visit a patient actually received during the study, up to Day 349 after baseline).

ID	Title	Description
OG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	JARDIANCE DUO® (Empagliflozin/Metformin)	All subjects who had Type 2 Diabetes Mellitus (T2DM), were initially administered orally various dosages of Jardiance Duo® tablet (Jardiance Duo® (empagliflozin/metformin) tablet dosages: 5/500 milligrams (mg), 5/850 mg, 5/1000 mg, 12.5/500 mg, 12.5/850 mg, 12.5/1000 mg) following the baseline (Visit 1) for an administration for 24 weeks, and with the case report forms (CRFs) retrieving at 20 sites from 21 January 2016 till 11 August 2020. Each patient was planned to be visited once at baseline (Visit 1), followed by 2 planned follow-up visits at Week 12 (after 12 weeks of medication administration) and at Week 24 (after 24 weeks of medication administration).	0	620	10	620	0	620

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk
Cerebral infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 affected620 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 affected620 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases