Empagliflozin as Adjunctive to Insulin Therapy Over 26 We... | NCT02580591

ID	Type	Description	Link
2014-005256-26	EudraCT Number

Name	Class
Eli Lilly and Company	INDUSTRY

Label	Type	Intervention Names
Empagliflozin low dose	Experimental	Drug: Empagliflozin Drug: Placebo
Empagliflozin high dose	Experimental	Drug: Empagliflozin Drug: Placebo
Empagliflozin medium dose	Experimental	Drug: Empagliflozin Drug: Placebo
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Empagliflozin	Drug		Empagliflozin high dose Empagliflozin low dose Empagliflozin medium dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])	Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.	Baseline to week 26
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD))	Change from baseline in Glycated hemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.	Baseline to week 26

Secondary Outcomes

Measure	Description	Time Frame
Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG)	Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints.

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Healthscan Clinical Trials LLC		Montgomery	Alabama	36106	United States
John Muir Physician Network Clinical Research Center

PubMed Identifier	Type	Citation	Retractions
37616393	Derived	Song C, Dhaliwal S, Bapat P, Scarr D, Bakhsh A, Budhram D, Verhoeff NJ, Weisman A, Fralick M, Ivers NM, Cherney DZI, Tomlinson G, Lovblom LE, Mumford D, Perkins BA. Point-of-Care Capillary Blood Ketone Measurements and the Prediction of Future Ketoacidosis Risk in Type 1 Diabetes. Diabetes Care. 2023 Nov 1;46(11):1973-1977. doi: 10.2337/dc23-0840.
30287422

ID	Title	Description
FG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
FG001	Empagliflozin 2.5 Milligram (mg)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 21, 2016	Sep 19, 2018

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

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])

Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

Full analysis set (FAS) (observed cases [OC]): Patients in the Treated Set (TS) who had a baseline and at least 1 on-treatment HbA1c measurement.

Posted

Least Squares Mean

Standard Error

Percentage (%)

Baseline to week 26

ID	Title	Description
OG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG002	Empagliflozin 10 mg	Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG003	Empagliflozin 25 mg	Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.

Units	Counts
Participants	OG000238 OG001237 OG002244 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.20± 0.05 OG001-0.09± 0.05 OG002-0.25± 0.05 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Model includes baseline HbA1c, baseline Estimated glomerular filtration rate (eGFR) as linear covariates and baseline pre-existing insulin therapy, treatment, visit, visit by treatment interaction, baseline HbA1c by visit interaction as fixed effects. Patient is included as random effect. An unstructured covariance structure was used to model the within-patient measurements.	Mixed effect Model Repeat Measurement		<0.0001		Mean Difference (Final Values)	-0.28	Standard Error of the Mean	0.07	2-Sided	99	-0.46	-0.11			Mean Difference= Empagliflozin 2.5 milligram (mg) adjusted mean - Placebo matching Empagliflozin adjusted mean.

Primary

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD))

Change from baseline in Glycated hemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

Modified intention-to-treat set (mITT) (observed case - all data [OC-AD]): Patients in the TS who had a baseline and at least 1 post-baseline HbA1c measurement.

Posted

Least Squares Mean

Standard Error

Percentage (%)

Baseline to week 26

ID	Title	Description
OG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG002	Empagliflozin 10 mg

Secondary

Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG)

Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints.

FAS (OC)

Posted

Least Squares Mean

95% Confidence Interval

Events per patient year

Week 5 to Week 26, Week 1 to Week 26

ID	Title	Description
OG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG002	Empagliflozin 10 mg

Secondary

Change From Baseline in Body Weight at Week 26

Change from baseline in body weight is presented With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

FAS (OC)

Posted

Least Squares Mean

Standard Error

Kilogram (kg)

Baseline to week 26

ID	Title	Description
OG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG002	Empagliflozin 10 mg	Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG003	Empagliflozin 25 mg

Secondary

Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26

Change from baseline in Total daily insulin dose (TDID) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

FAS (OC)

Posted

Least Squares Mean

Standard Error

Unit/kilogram (U/kg)

Baseline to week 26

ID	Title	Description
OG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG002	Empagliflozin 10 mg	Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG003

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26

Change from baseline in Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.

FAS observed cases excluding data after change in use of anti-hypertensives (OC-H)

Posted

Least Squares Mean

Standard Error

Millimeters of mercury (mmHg)

Baseline to week 26

ID	Title	Description
OG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
OG002	Empagliflozin 10 mg	Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG0031 affected245 at risk
Angina unstable	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0012 affected241 at risk EG0020 affected248 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Vestibular disorder	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Retinopathy haemorrhagic	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0022 affected248 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Pancreatolithiasis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0022 affected248 at risk EG003
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Appendicitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Gangrene	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0011 affected241 at risk EG0020 affected248 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Meningitis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0011 affected241 at risk EG0020 affected248 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Anion gap increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Blood bicarbonate increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Blood gases abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Blood glucose decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Blood glucose increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Blood ketone body increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Blood potassium increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Urine ketone body present	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Acetonaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0011 affected241 at risk EG0021 affected248 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected241 at risk EG0012 affected241 at risk EG0026 affected248 at risk EG003
Diabetic ketosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Euglycaemic diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected241 at risk EG0013 affected241 at risk EG0023 affected248 at risk EG003
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0011 affected241 at risk EG0023 affected248 at risk EG003
Ketosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0011 affected241 at risk EG0020 affected248 at risk EG003
Metabolic disorder	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected241 at risk EG0011 affected241 at risk EG0020 affected248 at risk EG003
Vaginal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0011 affected241 at risk EG0020 affected248 at risk EG003
Demyelination	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Major depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0021 affected248 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected241 at risk EG0010 affected241 at risk EG0020 affected248 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
BG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
BG002	Empagliflozin 10 mg	Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
BG003	Empagliflozin 25 mg	Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Matching Empagliflozin	Patients administered Placebo matching Empagliflozin film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.	0	241	16	241	153	241
EG001	Empagliflozin 2.5 Milligram (mg)	Patients administered Empagliflozin 2.5 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.	0	241	13	241	146	241
EG002	Empagliflozin 10 mg	Patients administered Empagliflozin 10 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.	0	248	21	248	172	248
EG003	Empagliflozin 25 mg	Patients administered Empagliflozin 25 mg film-coated tablet orally once daily in addition as adjunctive to optimized insulin therapy for 26 weeks.	1	245	16	245	162	245

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00024 affected241 at risk EG00123 affected241 at risk EG00222 affected248 at risk EG00326 affected245 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00012 affected241 at risk EG00112 affected241 at risk EG0029 affected248 at risk EG003
Blood ketone body increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0003 affected241 at risk EG0014 affected241 at risk EG00215 affected248 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG000144 affected241 at risk EG001137 affected241 at risk EG002162 affected248 at risk EG003