Trial Outcomes & Findings for Characteristics of Empagliflozin Initiators (NCT NCT03050619)

Results Overview

Baseline characteristics of adults (as measured by demographics) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.

Recruitment status

COMPLETED

Target enrollment

31908 participants

Primary outcome timeframe

Baseline

Results posted on

2019-01-25

Participant Flow

All study participants had at least 12 months of continuous registration in the United Kingdom (UK) Clinical Practice Research Datalink (CPRD) prior to the study initiation which is a data source comprising primary care electronic medical record (EMR).

Participant milestones

Participant milestones
Measure	Empagliflozin Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Overall Study STARTED	129	3926	6416	14007	6079	1351
Overall Study COMPLETED	129	3926	6416	14007	6079	1351
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Characteristics of Empagliflozin Initiators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Empagliflozin n=110 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3407 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5615 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=10370 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5271 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1155 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.	Total n=25928 Participants Total of all reporting groups
Age, Customized 18 - 35 years	6 Participants n=5 Participants	60 Participants n=7 Participants	81 Participants n=5 Participants	314 Participants n=4 Participants	141 Participants n=21 Participants	37 Participants n=8 Participants	639 Participants n=8 Participants
Age, Customized 36 - 49 years	25 Participants n=5 Participants	637 Participants n=7 Participants	643 Participants n=5 Participants	1748 Participants n=4 Participants	753 Participants n=21 Participants	224 Participants n=8 Participants	4030 Participants n=8 Participants
Age, Customized 50 - 64 years	47 Participants n=5 Participants	1683 Participants n=7 Participants	1952 Participants n=5 Participants	3858 Participants n=4 Participants	1925 Participants n=21 Participants	560 Participants n=8 Participants	10025 Participants n=8 Participants
Age, Customized 65 - 74 years	22 Participants n=5 Participants	862 Participants n=7 Participants	1601 Participants n=5 Participants	2576 Participants n=4 Participants	1347 Participants n=21 Participants	266 Participants n=8 Participants	6674 Participants n=8 Participants
Age, Customized 75 years and above	10 Participants n=5 Participants	165 Participants n=7 Participants	1338 Participants n=5 Participants	1874 Participants n=4 Participants	1105 Participants n=21 Participants	68 Participants n=8 Participants	4560 Participants n=8 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	1404 Participants n=7 Participants	2406 Participants n=5 Participants	4464 Participants n=4 Participants	2284 Participants n=21 Participants	571 Participants n=8 Participants	11180 Participants n=8 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	2003 Participants n=7 Participants	3209 Participants n=5 Participants	5906 Participants n=4 Participants	2987 Participants n=21 Participants	584 Participants n=8 Participants	14748 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by demographics) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.

Outcome measures

Outcome measures
Measure	Empagliflozin n=110 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3407 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5615 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=10370 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5271 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1155 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Age (36 - 49 years)	22.73 Percentage of Participants	18.70 Percentage of Participants	11.45 Percentage of Participants	16.86 Percentage of Participants	14.29 Percentage of Participants	19.39 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Age (50 - 64 years)	42.73 Percentage of Participants	49.40 Percentage of Participants	34.76 Percentage of Participants	37.20 Percentage of Participants	36.52 Percentage of Participants	48.48 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Age (65 - 74 years)	20.00 Percentage of Participants	25.30 Percentage of Participants	28.51 Percentage of Participants	24.84 Percentage of Participants	25.55 Percentage of Participants	23.03 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Gender (Male)	53.64 Percentage of Participants	58.79 Percentage of Participants	57.15 Percentage of Participants	56.95 Percentage of Participants	56.67 Percentage of Participants	50.56 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Age (18 - 35 years)	5.45 Percentage of Participants	1.76 Percentage of Participants	1.44 Percentage of Participants	3.03 Percentage of Participants	2.68 Percentage of Participants	3.20 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Age (75 years and above)	9.09 Percentage of Participants	4.84 Percentage of Participants	23.83 Percentage of Participants	18.07 Percentage of Participants	20.96 Percentage of Participants	5.89 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Gender (Female)	46.36 Percentage of Participants	41.21 Percentage of Participants	42.85 Percentage of Participants	43.05 Percentage of Participants	43.33 Percentage of Participants	49.44 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by life style factors (smoking and alcohol use)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. NA= NR (Not Reported) (variables for which patient counts were \<5)

Outcome measures

Outcome measures
Measure	Empagliflozin n=110 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3407 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5615 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=10370 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5271 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1155 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Smoking (smoker)	22.73 Percentage of Participants	18.08 Percentage of Participants	18.24 Percentage of Participants	20.67 Percentage of Participants	20.17 Percentage of Participants	18.53 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Smoking (non-smoker)	19.09 Percentage of Participants	29.03 Percentage of Participants	27.96 Percentage of Participants	30.95 Percentage of Participants	27.98 Percentage of Participants	27.01 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Smoking (ex-smoker)	58.18 Percentage of Participants	52.89 Percentage of Participants	53.80 Percentage of Participants	48.20 Percentage of Participants	51.79 Percentage of Participants	54.46 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Smoking (Unknown)	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	0.18 Percentage of Participants	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Alcohol consumption (drinker)	60.00 Percentage of Participants	68.59 Percentage of Participants	66.25 Percentage of Participants	68.14 Percentage of Participants	65.81 Percentage of Participants	65.45 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Alcohol consumption (Unknown)	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	2.35 Percentage of Participants	2.14 Percentage of Participants	4.67 Percentage of Participants	3.72 Percentage of Participants	2.34 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Alcohol consumption (non-drinker)	15.45 Percentage of Participants	9.25 Percentage of Participants	10.37 Percentage of Participants	10.15 Percentage of Participants	10.15 Percentage of Participants	9.18 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Alcohol consumption (ex-drinker)	22.73 Percentage of Participants	19.81 Percentage of Participants	21.25 Percentage of Participants	17.04 Percentage of Participants	20.32 Percentage of Participants	23.03 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by life style factors (BMI)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of body mass index (BMI) measured is presented along with number of subjects with available data.

Outcome measures

Outcome measures
Measure	Empagliflozin n=107 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3357 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5460 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=8964 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=4957 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1133 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	35.43 Kilogram per square meter (kg/m2) Standard Deviation 5.83	35.24 Kilogram per square meter (kg/m2) Standard Deviation 6.82	32.13 Kilogram per square meter (kg/m2) Standard Deviation 6.45	32.99 Kilogram per square meter (kg/m2) Standard Deviation 6.83	31.61 Kilogram per square meter (kg/m2) Standard Deviation 6.57	37.68 Kilogram per square meter (kg/m2) Standard Deviation 6.72

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by life style factors (blood pressure)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) measured is presented along with number of subjects with available data.

Outcome measures

Outcome measures
Measure	Empagliflozin n=110 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3407 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5615 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=10370 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5271 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1155 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK SBP	130.75 Millimeter of mercury (mmHg) Standard Deviation 14.72	133.52 Millimeter of mercury (mmHg) Standard Deviation 13.70	133.45 Millimeter of mercury (mmHg) Standard Deviation 14.61	135.02 Millimeter of mercury (mmHg) Standard Deviation 15.57	132.72 Millimeter of mercury (mmHg) Standard Deviation 14.86	133.84 Millimeter of mercury (mmHg) Standard Deviation 14.31
Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK DBP	77.02 Millimeter of mercury (mmHg) Standard Deviation 8.24	77.85 Millimeter of mercury (mmHg) Standard Deviation 8.91	76.02 Millimeter of mercury (mmHg) Standard Deviation 9.46	78.48 Millimeter of mercury (mmHg) Standard Deviation 10.19	76.78 Millimeter of mercury (mmHg) Standard Deviation 9.54	77.82 Millimeter of mercury (mmHg) Standard Deviation 8.67

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by glycated haemoglobin (HbA1c)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of glycated haemoglobin (HbA1c) measured is presented along with number of subjects with available data.

Outcome measures

Outcome measures
Measure	Empagliflozin n=97 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=2954 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=4849 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=8132 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=4290 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1036 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	77.34 Millimole per mole (mmol/mol) Standard Deviation 16.02	79.52 Millimole per mole (mmol/mol) Standard Deviation 17.62	73.83 Millimole per mole (mmol/mol) Standard Deviation 17.81	70.35 Millimole per mole (mmol/mol) Standard Deviation 20.98	78.05 Millimole per mole (mmol/mol) Standard Deviation 21.39	80.68 Millimole per mole (mmol/mol) Standard Deviation 18.07

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by laboratory tests) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Mean and standard deviation (SD) of total cholesterol (TC), high-density lipoproteins level (HDL), Low-density lipoprotein level (LDL) and triglyceride level (TG) measured are presented along with number of subjects with available data.

Outcome measures

Outcome measures
Measure	Empagliflozin n=110 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3407 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5615 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=10370 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5271 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1155 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK TC	4.22 Millimole per liter (mmol/L) Standard Deviation 1.00	4.33 Millimole per liter (mmol/L) Standard Deviation 1.10	4.29 Millimole per liter (mmol/L) Standard Deviation 1.09	4.89 Millimole per liter (mmol/L) Standard Deviation 1.26	4.53 Millimole per liter (mmol/L) Standard Deviation 1.27	4.37 Millimole per liter (mmol/L) Standard Deviation 1.05
Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK HDL	1.10 Millimole per liter (mmol/L) Standard Deviation 0.25	1.13 Millimole per liter (mmol/L) Standard Deviation 0.30	1.17 Millimole per liter (mmol/L) Standard Deviation 0.33	1.19 Millimole per liter (mmol/L) Standard Deviation 0.33	1.18 Millimole per liter (mmol/L) Standard Deviation 0.35	1.10 Millimole per liter (mmol/L) Standard Deviation 0.27
Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK LDL	2.17 Millimole per liter (mmol/L) Standard Deviation 0.85	2.19 Millimole per liter (mmol/L) Standard Deviation 0.86	2.19 Millimole per liter (mmol/L) Standard Deviation 0.90	2.70 Millimole per liter (mmol/L) Standard Deviation 1.01	2.32 Millimole per liter (mmol/L) Standard Deviation 0.97	2.22 Millimole per liter (mmol/L) Standard Deviation 0.88
Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK TG	2.22 Millimole per liter (mmol/L) Standard Deviation 1.33	2.38 Millimole per liter (mmol/L) Standard Deviation 1.89	2.23 Millimole per liter (mmol/L) Standard Deviation 1.63	2.34 Millimole per liter (mmol/L) Standard Deviation 1.90	2.43 Millimole per liter (mmol/L) Standard Deviation 1.99	2.50 Millimole per liter (mmol/L) Standard Deviation 1.72

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by estimated glomerular filtration rate (eGFR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of estimated glomerular filtration rate (eGFR) measured is presented along with number of subjects with available data.

Outcome measures

Outcome measures
Measure	Empagliflozin n=107 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3315 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5467 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=9609 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5020 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1097 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	95.46 Milliliters per minute (ml/min) Standard Deviation 16.94	93.42 Milliliters per minute (ml/min) Standard Deviation 30.95	80.68 Milliliters per minute (ml/min) Standard Deviation 24.65	87.64 Milliliters per minute (ml/min) Standard Deviation 19.56	84.95 Milliliters per minute (ml/min) Standard Deviation 23.12	90.27 Milliliters per minute (ml/min) Standard Deviation 20.44

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by by creatinine serum (SCR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of creatinine serum (SCR) measured is presented along with number of subjects with available data.

Outcome measures

Outcome measures
Measure	Empagliflozin n=107 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3315 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5467 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=9609 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5020 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1097 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK	72.16 Micromoles per liter (umol/L) Standard Deviation 16.62	74.52 Micromoles per liter (umol/L) Standard Deviation 17.18	88.46 Micromoles per liter (umol/L) Standard Deviation 38.30	78.46 Micromoles per liter (umol/L) Standard Deviation 20.00	83.10 Micromoles per liter (umol/L) Standard Deviation 33.18	77.16 Micromoles per liter (umol/L) Standard Deviation 23.97

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by comorbidities) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.

Outcome measures

Outcome measures
Measure	Empagliflozin n=110 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3407 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5615 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=10370 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5271 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1155 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Diabetes complications	34.55 Percentage of Participants	34.14 Percentage of Participants	33.62 Percentage of Participants	13.11 Percentage of Participants	24.36 Percentage of Participants	34.81 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Thyroid disorders	8.18 Percentage of Participants	9.30 Percentage of Participants	9.39 Percentage of Participants	8.52 Percentage of Participants	8.97 Percentage of Participants	11.00 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Cancer	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	4.05 Percentage of Participants	7.25 Percentage of Participants	5.97 Percentage of Participants	7.95 Percentage of Participants	4.59 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Cardiovascular disorders	56.36 Percentage of Participants	56.88 Percentage of Participants	62.60 Percentage of Participants	54.85 Percentage of Participants	59.70 Percentage of Participants	59.83 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Infections	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	2.03 Percentage of Participants	3.69 Percentage of Participants	2.64 Percentage of Participants	3.68 Percentage of Participants	3.64 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Kidney disease	11.82 Percentage of Participants	9.48 Percentage of Participants	22.81 Percentage of Participants	12.40 Percentage of Participants	17.40 Percentage of Participants	14.98 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Polycystic Ovary Syndrome (PCO), females only	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	1.78 Percentage of Participants	1.37 Percentage of Participants	1.52 Percentage of Participants	1.80 Percentage of Participants	3.33 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Obesity	40.00 Percentage of Participants	39.01 Percentage of Participants	26.79 Percentage of Participants	20.69 Percentage of Participants	24.45 Percentage of Participants	45.71 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Respiratory	22.73 Percentage of Participants	21.10 Percentage of Participants	19.89 Percentage of Participants	19.59 Percentage of Participants	20.13 Percentage of Participants	21.90 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Bone disorders	8.18 Percentage of Participants	11.39 Percentage of Participants	12.80 Percentage of Participants	12.10 Percentage of Participants	13.15 Percentage of Participants	12.55 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Pancreatitis	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	1.14 Percentage of Participants	0.89 Percentage of Participants	1.02 Percentage of Participants	1.37 Percentage of Participants	0.52 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline

Population: All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

Baseline characteristics of adults (as measured by concomitant medications) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Subjects taking medication up to 60 days before index date are presented.

Outcome measures

Outcome measures
Measure	Empagliflozin n=110 Participants Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015.	Other SGLT-2i n=3407 Participants Subjects who initiated treatment with other sodium glucose cotransporter 2 inhibitors (SGLT-2i) in the UK between 01 August 2014 and 01 September 2015.	Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) n=5615 Participants Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015.	Metformin n=10370 Participants Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015.	Sulfonylureas (SU) n=5271 Participants Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015.	Glucagon-like Peptide-1 (GLP-1) Agonists n=1155 Participants Subjects who initiated treatment with GLP-1 agonists in the UK between 01 August 2014 and 01 September 2015.
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Insulin	15.45 Percentage of Participants	17.64 Percentage of Participants	5.95 Percentage of Participants	2.34 Percentage of Participants	2.26 Percentage of Participants	18.18 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Non-insulin GLDs	96.36 Percentage of Participants	95.42 Percentage of Participants	89.26 Percentage of Participants	10.49 Percentage of Participants	78.54 Percentage of Participants	92.81 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Cardiovascular medications	70.91 Percentage of Participants	74.76 Percentage of Participants	76.31 Percentage of Participants	60.35 Percentage of Participants	69.42 Percentage of Participants	77.40 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Lipid-regulating Drugs	79.09 Percentage of Participants	76.20 Percentage of Participants	74.37 Percentage of Participants	47.92 Percentage of Participants	64.81 Percentage of Participants	75.67 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Oral Corticosteroids	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	2.76 Percentage of Participants	4.49 Percentage of Participants	4.99 Percentage of Participants	5.86 Percentage of Participants	2.94 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Non-steroidal anti-inflammatory drugs	8.18 Percentage of Participants	10.92 Percentage of Participants	8.39 Percentage of Participants	9.47 Percentage of Participants	8.06 Percentage of Participants	11.69 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Psycholeptics	5.45 Percentage of Participants	5.14 Percentage of Participants	5.40 Percentage of Participants	5.73 Percentage of Participants	6.00 Percentage of Participants	6.49 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Antipsychotics	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	3.08 Percentage of Participants	3.51 Percentage of Participants	3.85 Percentage of Participants	3.74 Percentage of Participants	3.90 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Antidepressants	31.82 Percentage of Participants	26.71 Percentage of Participants	22.87 Percentage of Participants	21.41 Percentage of Participants	23.20 Percentage of Participants	33.94 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Opiates	22.73 Percentage of Participants	21.19 Percentage of Participants	20.11 Percentage of Participants	18.57 Percentage of Participants	20.05 Percentage of Participants	24.33 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Anti-Epilepsy, Anticonvulsants	9.09 Percentage of Participants	9.01 Percentage of Participants	9.58 Percentage of Participants	8.39 Percentage of Participants	8.95 Percentage of Participants	13.25 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Anti-Parkinson, Dopamine agonists	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	2.26 Percentage of Participants	2.49 Percentage of Participants	2.80 Percentage of Participants	2.79 Percentage of Participants	2.86 Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK Agents for dementia	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.	0.18 Percentage of Participants	0.80 Percentage of Participants	0.58 Percentage of Participants	0.61 Percentage of Participants	NA Percentage of Participants CPRD policy is that no cell that contains \<5 events should be reported, to protect patient confidentiality.

SECONDARY outcome

Timeframe: Baseline

Population: All patients (without any age restriction), with or without a recorded diagnosis of diabetes, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.

To assess off-label use the number of study participants without a recorded diagnosis of T2DM was calculated for each exposure category (people with other types of diabetes, people without diabetes, people younger than 18 years old, and women during pregnancy and breastfeeding). For the assessment of drug use during the pregnancy and breastfeeding period, the look-back period was 270 days (9 months) before and including the index date. To assess the use in pediatric population, the study participants were stratified by age into adults (≥18 years of age) and pediatrics (\<18 years of age).