CClinicalTrials.gg
Sign In
CompletedNCT03050619Updated Jan 25, 2019Results posted

Characteristics of Empagliflozin Initiators

An observational study in Type 2 Diabetes, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
31,908
Sex
All
01

Study summary

Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the United Kingdom (UK) in August 2014. It can be expected that patients initiating empagliflozin may differ in their characteristics from patients initiating other glucose lowering drugs (GLDs) that have been on the market longer (e.g. patients may have poorer glucose control). Therefore, the proposed study aims to characterize patients with T2DM in the UK initiating empagliflozin in terms of baseline characteristics, concomitant medications, and comorbidities compared to patients with type 2 diabetes mellitus (T2DM) initiating other SGLT-2 inhibitors or other non-insulin GLDs. Due to the mode of action, some patients taking empagliflozin have experienced weight loss in clinical trials. A theoretical possibility exists that empagliflozin may be used by patients without T2DM. Therefore, this study also aims to assess the potential off-label use of empagliflozin compared to other non-insulin GLDs.

Read the detailed description

Study Design:

cross sectional

02

Conditions studied

  • Type 2 Diabetes
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

New users of empagliflozin and other non-insulin GLDs in the UK CPRD between 1 Aug 2014 to 1 Sep 2015

Inclusion criteria

All patients will be required to meet all of the following criteria:

  • At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Datalink (CPRD). Infants younger than 1 year will not be required to have 12 months of continuous UTS registration in the CPRD.
  • A new user of one of the index prescriptions (empagliflozin, other SGLT2 inhibitor, or non-insulin GLDs) or a fixed dose combination (FDC) with metformin.

Exclusion criteria

Exclusion criteria:

There is no exclusion criterion in this study.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
31,908 participants (actual)
Patient registry
No

Groups and cohorts

  • New users of Empagliflozin

    New users of empagliflozin

    Drug: Empagliflozin

  • New users of Other SGLT2 inhibitors

    New users of other SGLT2 inhibitors

    Drug: Other SGLT2 inhibitors

  • New users of Other non-insulin GLDs

    New users of other non-insulin GLDs

    Drug: Other non-insulin GLDs

Interventions

  • DrugEmpagliflozin
  • DrugOther SGLT2 inhibitors
  • DrugOther non-insulin GLDs

    metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists

06

What researchers measure

Primary outcomes

  1. Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  2. 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

    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)

    Time frame: Baseline

  3. Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  4. Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  5. Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  6. Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  7. Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  8. Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  9. Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

  10. Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

    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.

    Time frame: Baseline

Secondary outcomes

  1. Extent of Off-label Use

    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).

    Time frame: Baseline

  2. Baseline Characteristics (as Measured by Demographics) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by demographics) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  3. Baseline Characteristics (as Measured by Life Style Factors (Smoking and Alcohol Use)) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by life style factors (smoking and alcohol use)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. NA= NR (Not Reported) (variables for which patient counts were \<5)

    Time frame: Baseline

  4. Baseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by life style factors (BMI)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  5. Baseline Characteristics (as Measured by Life Style Factors (Blood Pressure)) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by life style factors (blood pressure)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  6. Baseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by glycated haemoglobin (HbA1c)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  7. Baseline Characteristics (as Measured by Laboratory Tests) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by laboratory tests) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  8. Baseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by estimated glomerular filtration rate (eGFR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  9. Baseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by creatinine serum (SCR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  10. Baseline Characteristics (as Measured by Comorbidities) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by comorbidities) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

    Time frame: Baseline

  11. Baseline Characteristics (as Measured by Concomitant Medications) of Patients Starting Index Prescriptions Off-label

    Baseline characteristics of patients (as measured by concomitant medications) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. Subjects taking medication up to 60 days before index date are presented.

    Time frame: Baseline

07

Results

Posted Jan 25, 2019
Limitations and caveats
The utilization of empagliflozin in the first year after launch was not as high as other exposure categories.

Participant flow

Participant flow — Overall Study
MilestoneEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Started129392664161400760791351
Completed129392664161400760791351
Not completed000000

Outcome measures

PrimaryBaseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Number · Percentage of Participants
Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Age (18 - 35 years)5.451.761.443.032.683.20
Age (36 - 49 years)22.7318.7011.4516.8614.2919.39
Age (50 - 64 years)42.7349.4034.7637.2036.5248.48
Age (65 - 74 years)20.0025.3028.5124.8425.5523.03
Age (75 years and above)9.094.8423.8318.0720.965.89
Gender (Female)46.3641.2142.8543.0543.3349.44
Gender (Male)53.6458.7957.1556.9556.6750.56
PrimaryBaseline 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

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)

Time frame:
Baseline
Reported as:
Number · 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
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Smoking (smoker)22.7318.0818.2420.6720.1718.53
Smoking (non-smoker)19.0929.0327.9630.9527.9827.01
Smoking (ex-smoker)58.1852.8953.8048.2051.7954.46
Smoking (Unknown)NANANA0.18NANA
Alcohol consumption (drinker)60.0068.5966.2568.1465.8165.45
Alcohol consumption (non-drinker)15.459.2510.3710.1510.159.18
Alcohol consumption (ex-drinker)22.7319.8121.2517.0420.3223.03
Alcohol consumption (Unknown)NA2.352.144.673.722.34
PrimaryBaseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Mean · Kilogram per square meter (kg/m2)
Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Kilogram per square meter (kg/m2)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK35.43 ± 5.8335.24 ± 6.8232.13 ± 6.4532.99 ± 6.8331.61 ± 6.5737.68 ± 6.72
PrimaryBaseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Mean · Millimeter of mercury (mmHg)
Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Millimeter of mercury (mmHg)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
SBP130.75 ± 14.72133.52 ± 13.70133.45 ± 14.61135.02 ± 15.57132.72 ± 14.86133.84 ± 14.31
DBP77.02 ± 8.2477.85 ± 8.9176.02 ± 9.4678.48 ± 10.1976.78 ± 9.5477.82 ± 8.67
PrimaryBaseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Mean · Millimole per mole (mmol/mol)
Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Millimole per mole (mmol/mol)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK77.34 ± 16.0279.52 ± 17.6273.83 ± 17.8170.35 ± 20.9878.05 ± 21.3980.68 ± 18.07
PrimaryBaseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Mean · Millimole per liter (mmol/L)
Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Millimole per liter (mmol/L)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
TC4.22 ± 1.004.33 ± 1.104.29 ± 1.094.89 ± 1.264.53 ± 1.274.37 ± 1.05
HDL1.10 ± 0.251.13 ± 0.301.17 ± 0.331.19 ± 0.331.18 ± 0.351.10 ± 0.27
LDL2.17 ± 0.852.19 ± 0.862.19 ± 0.902.70 ± 1.012.32 ± 0.972.22 ± 0.88
TG2.22 ± 1.332.38 ± 1.892.23 ± 1.632.34 ± 1.902.43 ± 1.992.50 ± 1.72
PrimaryBaseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Mean · Milliliters per minute (ml/min)
Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Milliliters per minute (ml/min)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK95.46 ± 16.9493.42 ± 30.9580.68 ± 24.6587.64 ± 19.5684.95 ± 23.1290.27 ± 20.44
PrimaryBaseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Mean · Micromoles per liter (umol/L)
Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Micromoles per liter (umol/L)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK72.16 ± 16.6274.52 ± 17.1888.46 ± 38.3078.46 ± 20.0083.10 ± 33.1877.16 ± 23.97
PrimaryBaseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Number · Percentage of Participants
Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Diabetes complications34.5534.1433.6213.1124.3634.81
Thyroid disorders8.189.309.398.528.9711.00
CancerNA4.057.255.977.954.59
Cardiovascular disorders56.3656.8862.6054.8559.7059.83
InfectionsNA2.033.692.643.683.64
Kidney disease11.829.4822.8112.4017.4014.98
Polycystic Ovary Syndrome (PCO), females onlyNA1.781.371.521.803.33
Obesity40.0039.0126.7920.6924.4545.71
Respiratory22.7321.1019.8919.5920.1321.90
PancreatitisNA1.140.891.021.370.52
Bone disorders8.1811.3912.8012.1013.1512.55
PrimaryBaseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK

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.

Time frame:
Baseline
Reported as:
Number · Percentage of Participants
Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Insulin15.4517.645.952.342.2618.18
Non-insulin GLDs96.3695.4289.2610.4978.5492.81
Cardiovascular medications70.9174.7676.3160.3569.4277.40
Lipid-regulating Drugs79.0976.2074.3747.9264.8175.67
Oral CorticosteroidsNA2.764.494.995.862.94
Non-steroidal anti-inflammatory drugs8.1810.928.399.478.0611.69
Psycholeptics5.455.145.405.736.006.49
AntipsychoticsNA3.083.513.853.743.90
Antidepressants31.8226.7122.8721.4123.2033.94
Opiates22.7321.1920.1118.5720.0524.33
Anti-Epilepsy, Anticonvulsants9.099.019.588.398.9513.25
Anti-Parkinson, Dopamine agonistsNA2.262.492.802.792.86
Agents for dementiaNA0.180.800.580.61NA
SecondaryExtent of Off-label Use

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).

Time frame:
Baseline
Reported as:
Number · Participants
Extent of Off-label Use
ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Gestational diabetes, pregnancy, or breastfeeding04258180
Without any diabetes mellitus (DM) code031316011361
Type 1 diabetes mellitus (T1DM)145211593010
Unspecified DM143455691054478122
Other diabetes02320221
Mixed codes of DM412019221813362
Younger than 18 years with T2DM000410
SecondaryBaseline Characteristics (as Measured by Demographics) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by demographics) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Number · Percentage of Participants
Baseline Characteristics (as Measured by Demographics) of Patients Starting Index Prescriptions Off-label
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Age (18 - 35 years)NA2.600.8811.442.514.10
Age (36 - 49 years)NA19.6510.7219.6412.3417.21
Age (50 - 64 years)42.8645.9530.9331.6535.3645.90
Age (65 - 74 years)NA24.8630.2321.6425.1025.41
Age (75 years and above)NA6.9427.2415.6324.697.38
Gender (Female)35.7142.4940.6048.9044.5655.74
Gender (Male)64.2957.5159.4051.1055.4444.26
SecondaryBaseline Characteristics (as Measured by Life Style Factors (Smoking and Alcohol Use)) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by life style factors (smoking and alcohol use)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. NA= NR (Not Reported) (variables for which patient counts were \<5)

Time frame:
Baseline
Reported as:
Number · Percentage of Participants
Baseline Characteristics (as Measured by Life Style Factors (Smoking and Alcohol Use)) of Patients Starting Index Prescriptions Off-label
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Smoking (smoker)NA23.9916.3422.2122.5913.93
Smoking (non-smoker)42.8632.3731.8135.4633.8937.70
Smoking (ex-smoker)35.7143.6451.8542.2343.5148.36
Smoking (Unknown)NANANANANANA
Alcohol consumption (drinker)64.2962.7262.2164.2559.8358.20
Alcohol consumption (non-drinker)NA12.1415.4713.1615.4813.11
Alcohol consumption (ex-drinker)NA21.6817.0514.8717.3622.95
Alcohol consumption (Unknown)NA3.475.277.727.325.74
SecondaryBaseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by life style factors (BMI)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Mean · Kilogram per square meter (kg/m2)
Baseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label
Kilogram per square meter (kg/m2)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label33.29 ± 5.7734.71 ± 6.6631.73 ± 6.4032.40 ± 7.2130.81 ± 6.4936.50 ± 6.43
SecondaryBaseline Characteristics (as Measured by Life Style Factors (Blood Pressure)) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by life style factors (blood pressure)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Mean · Millimeter of mercury (mmHg)
Baseline Characteristics (as Measured by Life Style Factors (Blood Pressure)) of Patients Starting Index Prescriptions Off-label
Millimeter of mercury (mmHg)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
SBP131.43 ± 12.79133.94 ± 15.97134.41 ± 16.19134.95 ± 16.96130.86 ± 14.86133.18 ± 14.58
DBP75.43 ± 5.2476.85 ± 9.9375.42 ± 9.6678.74 ± 11.0275.89 ± 10.0075.97 ± 10.20
SecondaryBaseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by glycated haemoglobin (HbA1c)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Mean · Millimole per mole (mmol/mol)
Baseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label
Millimole per mole (mmol/mol)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label79.69 ± 13.7982.17 ± 18.4574.70 ± 17.5572.29 ± 23.9479.21 ± 23.5583.23 ± 19.86
SecondaryBaseline Characteristics (as Measured by Laboratory Tests) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by laboratory tests) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Mean · Millimole per liter (mmol/L)
Baseline Characteristics (as Measured by Laboratory Tests) of Patients Starting Index Prescriptions Off-label
Millimole per liter (mmol/L)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
TC3.96 ± 0.934.33 ± 1.144.25 ± 1.184.95 ± 1.294.49 ± 1.244.40 ± 1.17
HDL1.16 ± 0.391.14 ± 0.321.17 ± 0.311.22 ± 0.391.19 ± 0.311.15 ± 0.35
LDL2.08 ± 1.052.24 ± 0.962.15 ± 0.862.73 ± 1.022.27 ± 0.952.09 ± 0.98
TG1.84 ± 1.172.38 ± 1.762.15 ± 1.472.43 ± 2.342.27 ± 1.512.38 ± 1.41
SecondaryBaseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by estimated glomerular filtration rate (eGFR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Mean · Milliliters per minute (ml/min)
Baseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label
Milliliters per minute (ml/min)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label91.05 ± 17.0193.23 ± 16.8978.52 ± 25.2089.36 ± 20.9982.31 ± 25.0985.57 ± 21.19
SecondaryBaseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by creatinine serum (SCR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Mean · Micromoles per liter (umol/L)
Baseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label
Micromoles per liter (umol/L)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Baseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label74.21 ± 17.7674.10 ± 19.2892.89 ± 47.4978.21 ± 23.5387.41 ± 43.4781.97 ± 26.08
SecondaryBaseline Characteristics (as Measured by Comorbidities) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by comorbidities) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.

Time frame:
Baseline
Reported as:
Number · Percentage of Participants
Baseline Characteristics (as Measured by Comorbidities) of Patients Starting Index Prescriptions Off-label
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
Diabetes complicationsNA47.6937.2614.5927.4140.98
Thyroid disordersNA5.206.338.295.444.92
CancerNA2.895.984.966.905.74
Cardiovascular disorders35.7144.5151.6741.3744.9843.44
InfectionsNA2.022.993.913.564.10
Kidney diseaseNA8.9623.909.3415.0615.57
Polycystic Ovary Syndrome (PCO), females onlyNANANA11.70NANA
ObesityNA24.5715.2917.1613.8127.87
RespiratoryNA15.9018.6316.0218.4122.13
PancreatitisNANANA0.95NANA
Bone disordersNA8.679.3110.9611.304.92
SecondaryBaseline Characteristics (as Measured by Concomitant Medications) of Patients Starting Index Prescriptions Off-label

Baseline characteristics of patients (as measured by concomitant medications) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains \<5 events should be reported to protect patient confidentiality. Since empagliflozin group reported \<5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. Subjects taking medication up to 60 days before index date are presented.

Time frame:
Baseline
Reported as:
Number · Percentage of Participants
Baseline Characteristics (as Measured by Concomitant Medications) of Patients Starting Index Prescriptions Off-label
Percentage of ParticipantsEmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) Agonists
InsulinNA33.8212.139.253.7736.07
Non-insulin GLDs85.7191.3385.0611.4470.0884.43
Cardiovascular medications85.7177.1779.9652.2466.5374.59
Lipid-regulating Drugs85.7175.1475.2238.4258.5872.95
Oral CorticosteroidsNA1.453.164.293.56NA
Non-steroidal anti-inflammatory drugsNA10.126.858.878.7913.93
PsycholepticsNA8.095.987.158.795.74
AntipsychoticsNA3.763.873.432.724.92
AntidepressantsNA30.9226.0121.8326.9932.79
OpiatesNA28.6122.1419.7322.3826.23
Anti-Epilepsy, AnticonvulsantsNA15.9010.029.446.9013.11
Anti-Parkinson, Dopamine agonistsNA2.312.642.292.93NA
Agents for dementiaNANA1.05NA1.26NA

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Empagliflozin———
Other SGLT-2i———
Dipeptidyl Peptidase-4 Inhibitors (DPP-4i)———
Metformin———
Sulfonylureas (SU)———
Glucagon-like Peptide-1 (GLP-1) Agonists———

Baseline characteristics

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

Age, Customized
Age, Customized(Participants)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) AgonistsTotal
18 - 35 years6608131414137639
36 - 49 years2563764317487532244030
50 - 64 years47168319523858192556010025
65 - 74 years228621601257613472666674
75 years and above10165133818741105684560
Sex: Female, Male
Sex: Female, Male(Participants)EmpagliflozinOther SGLT-2iDipeptidyl Peptidase-4 Inhibitors (DPP-4i)MetforminSulfonylureas (SU)Glucagon-like Peptide-1 (GLP-1) AgonistsTotal
Female51140424064464228457111180
Male59200332095906298758414748
08

Study locations

1 site
  • Boehringer Ingelheim Investigational Site
    Ingelheim, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03050619
Lead sponsor
Boehringer Ingelheim
Collaborators
Eli Lilly and Company
Responsible party
Sponsor
First posted
Feb 13, 2017
Start date
Sep 10, 2016
Primary completion
Oct 14, 2016
Completion
Oct 14, 2016
Results posted
Jan 25, 2019
Last update
Jan 25, 2019

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Boehringer Ingelheim

Start the discussion