Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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.
Study Design:
cross sectional
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New users of Empagliflozin | New users of empagliflozin |
| |
| New users of Other SGLT2 inhibitors | New users of other SGLT2 inhibitors |
| |
| New users of Other non-insulin GLDs | New users of other non-insulin GLDs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug |
| ||
| Other SGLT2 inhibitors |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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) | Baseline |
| 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. | Baseline |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion criteria:
All patients will be required to meet all of the following criteria:
Exclusion criteria:
There is no exclusion criterion in this study.
Not provided
Not provided
Not provided
Not provided
New users of empagliflozin and other non-insulin GLDs in the UK CPRD between 1 Aug 2014 to 1 Sep 2015
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
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).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Empagliflozin | Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015. |
| FG001 | 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. |
| FG002 | Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) | Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015. |
| FG003 | Metformin | Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015. |
| FG004 | Sulfonylureas (SU) | Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Empagliflozin | Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Percentage of Participants | Baseline |
|
Not provided
Based on current guidelines from the International Society for Pharmacoepidemiology and good pharmacovigilance practices (GVP) Module VI, reporting of adverse reactions in noninterventional studies conducted using electronic claims and health care records (based on use of secondary data) is not required.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Empagliflozin | Subjects who initiated treatment with empagliflozin in the United Kingdom (UK) between 01 August 2014 and 01 September 2015. |
Not provided
Not provided
The utilization of empagliflozin in the first year after launch was not as high as other exposure categories.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570240 | empagliflozin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Other non-insulin GLDs | Drug | metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists |
|
| Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| Baseline |
| 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. | Baseline |
| 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) | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| 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. | Baseline |
| BG002 | Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) | Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015. |
| BG003 | Metformin | Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015. |
| BG004 | Sulfonylureas (SU) | Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015. |
| BG005 | 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. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) | Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015. |
| OG003 | Metformin | Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015. |
| OG004 | Sulfonylureas (SU) | Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015. |
| OG005 | 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. |
|
|
| Primary | 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) | 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. | Posted | Number | Percentage of Participants | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Kilogram per square meter (kg/m2) | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Millimole per mole (mmol/mol) | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Millimole per liter (mmol/L) | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Milliliters per minute (ml/min) | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Number | Percentage of Participants | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Number | Percentage of Participants | Baseline |
|
|
|
| Secondary | 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). | 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. | Posted | Number | Participants | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Number | Percentage of Participants | Baseline |
|
|
|
| Secondary | 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) | All patients older than 18 years with unspecified DM 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. | Posted | Number | Percentage of Participants | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Mean | Standard Deviation | Kilogram per square meter (kg/m2) | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Mean | Standard Deviation | Millimole per mole (mmol/mol) | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Mean | Standard Deviation | Millimole per liter (mmol/L) | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Mean | Standard Deviation | Milliliters per minute (ml/min) | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Number | Percentage of Participants | Baseline |
|
|
|
| Secondary | 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. | All patients older than 18 years with unspecified DM 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. | Posted | Number | Percentage of Participants | Baseline |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
| EG002 | Dipeptidyl Peptidase-4 Inhibitors (DPP-4i) | Subjects who initiated treatment with DPP-4i in the UK between 01 August 2014 and 01 September 2015. | 0 | 0 | 0 | 0 |
| EG003 | Metformin | Subjects who initiated treatment with metformin in the UK between 01 August 2014 and 01 September 2015. | 0 | 0 | 0 | 0 |
| EG004 | Sulfonylureas (SU) | Subjects who initiated treatment with SU in the UK between 01 August 2014 and 01 September 2015. | 0 | 0 | 0 | 0 |
| EG005 | 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. | 0 | 0 | 0 | 0 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D004700 | Endocrine System Diseases |
| Smoking (non-smoker) |
|
| Smoking (ex-smoker) |
|
| Smoking (Unknown) |
|
| Alcohol consumption (drinker) |
|
| Alcohol consumption (non-drinker) |
|
| Alcohol consumption (ex-drinker) |
|
| Alcohol consumption (Unknown) |
|
|
| DBP |
|
|
|
| HDL |
|
|
| LDL |
|
|
| TG |
|
|
| Thyroid disorders |
|
| Cancer |
|
| Cardiovascular disorders |
|
| Infections |
|
| Kidney disease |
|
| Polycystic Ovary Syndrome (PCO), females only |
|
| Obesity |
|
| Respiratory |
|
| Pancreatitis |
|
| Bone disorders |
|
| Non-insulin GLDs |
|
| Cardiovascular medications |
|
| Lipid-regulating Drugs |
|
| Oral Corticosteroids |
|
| Non-steroidal anti-inflammatory drugs |
|
| Psycholeptics |
|
| Antipsychotics |
|
| Antidepressants |
|
| Opiates |
|
| Anti-Epilepsy, Anticonvulsants |
|
| Anti-Parkinson, Dopamine agonists |
|
| Agents for dementia |
|
| Without any diabetes mellitus (DM) code |
|
| Type 1 diabetes mellitus (T1DM) |
|
| Unspecified DM |
|
| Other diabetes |
|
| Mixed codes of DM |
|
| Younger than 18 years with T2DM |
|
| Age (36 - 49 years) |
|
| Age (50 - 64 years) |
|
| Age (65 - 74 years) |
|
| Age (75 years and above) |
|
| Gender (Female) |
|
| Gender (Male) |
|
| Smoking (non-smoker) |
|
| Smoking (ex-smoker) |
|
| Smoking (Unknown) |
|
| Alcohol consumption (drinker) |
|
| Alcohol consumption (non-drinker) |
|
| Alcohol consumption (ex-drinker) |
|
| Alcohol consumption (Unknown) |
|
|
| DBP |
|
|
|
| HDL |
|
|
| LDL |
|
|
| TG |
|
|
| Thyroid disorders |
|
| Cancer |
|
| Cardiovascular disorders |
|
| Infections |
|
| Kidney disease |
|
| Polycystic Ovary Syndrome (PCO), females only |
|
| Obesity |
|
| Respiratory |
|
| Pancreatitis |
|
| Bone disorders |
|
| Non-insulin GLDs |
|
| Cardiovascular medications |
|
| Lipid-regulating Drugs |
|
| Oral Corticosteroids |
|
| Non-steroidal anti-inflammatory drugs |
|
| Psycholeptics |
|
| Antipsychotics |
|
| Antidepressants |
|
| Opiates |
|
| Anti-Epilepsy, Anticonvulsants |
|
| Anti-Parkinson, Dopamine agonists |
|
| Agents for dementia |
|