Diabetes Mellitus, Type 2
Conditions
Brief summary
Description of the real-life treatment of adult patients with type-2 diabetes mellitus (T2DM) receiving Empagliflozin, comparing the characteristics of patients starting Empagliflozin in three time intervals
Interventions
DRUGEmpagliflozin
drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* At least two outpatient T2DM diagnoses (ICD E11.-) in two different quarters and/or at least one inpatient T2DM diagnosis (ICD E11) * At least one prescription of an empagliflozin-containing antidiabetic drug: Jardiance® (Empagliflozin, ATC A10BK03, former A10BX12) or Synjardy® (Empagliflozin/ Met¬for¬min, ATC A10BD20)
Exclusion criteria
* Any diagnosis of T1DM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities | At baseline. | Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure. |
| Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications | At baseline. | Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative). |
| Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | At baseline. | Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height of Participants | At baseline. | Height of participants. |
| Glycated Hemoglobin (HbA1c) | At baseline. | Glycated hemoglobin (HbA1c). |
| Duration of Diabetes | At baseline. | Duration of diabetes (time since diagnosis). |
| Percentage of Participants With Previous Glucose-lowering Treatment | At baseline. | Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation. |
| Percentage of Participants by Age Category | At baseline. | Percentage of participants by age category; younger than 65 (\< 65), from 65 to 74 (65 ≤ 75) , from 75 to 80 (75 - 80) , older than 80 (\> 80). |
| Number of Participants With Hospitalizations | At baseline. | Number of participants with hospitalizations. |
| Dosage of Empagliflozin | At baseline. | Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin. |
| Fasting Plasma Glucose (FPG) | At baseline. | Fasting plasma glucose (FPG). |
| Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes | At baseline. | Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes. |
| Percentage of Male Participants | At baseline. | The percentage of male participants is reported. |
| Weight of Participants | At baseline. | Weight of participants. |
Countries
Germany
Participant flow
Recruitment details
A retrospective real-world evidence study based on existing data to describe the treatment and population characteristics of patients with type-2 diabetes mellitus (T2DM) receiving empagliflozin in thee time intervals.
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Only patients that met all the inclusion and none of the exclusion criteria were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with type 2 diabetes mellitus (T2DM), registered between 2014 and 2019, receiving empagliflozin were used. Cohort 1 (early users) included only patients who received empagliflozin before the EMPA-REG OUTCOME study publication in mid-September 2015. | 505 |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 2 (intermediate users) included only patients who started empagliflozin after the EMPA-REG OUTCOME study publication (mid-September 2015), but before the European Medicines Agency label change (mid-January 2017). | 2,961 |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 Data from two german patient registries (Diabetes-Patienten-Verlaufs-Dokumentations (DPV) and Diabetes Versorgungs-Evaluation (DIVE)) on patients with T2DM, registered between 2014 and 2019, receiving empagliflozin were used. Cohort 3 (late users) included only patients who started empagliflozin after mid-January 2017 until last available data cut in September 2019. | 6,105 |
| Total | 9,571 |
Baseline characteristics
| Characteristic | Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Total |
|---|---|---|---|---|
| Age, Continuous | 59.2 Years STANDARD_DEVIATION 11.3 | 61.2 Years STANDARD_DEVIATION 11.5 | 63.2 Years STANDARD_DEVIATION 11.4 | 62.4 Years STANDARD_DEVIATION 11.5 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 248 Participants | 1131 Participants | 2045 Participants | 3424 Participants |
| Sex: Female, Male Male | 257 Participants | 1830 Participants | 4060 Participants | 6147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Antihypertensive drugs | 45.4 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Lipid-lowering agents | 28.3 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Antplatelet, anticoagulant drugs | 11.7 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Glucose-lowering therapies | 80.2 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Glucose-lowering therapies | 83.1 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Antihypertensive drugs | 49.5 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Antplatelet, anticoagulant drugs | 17.4 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Lipid-lowering agents | 36.4 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Glucose-lowering therapies | 90.6 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Lipid-lowering agents | 46.0 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Antplatelet, anticoagulant drugs | 25.3 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication | Antihypertensive drugs | 59.8 Percentage of participants |
Comparison: Antihypertensive drugsp-value: <0.001Chi-squared
Comparison: Lipid-lowering agentsp-value: <0.001Chi-squared
Comparison: Antiplatelet, anticoagulant drugsp-value: <0.001Chi-squared
Comparison: Glucose-lowering therapiesp-value: <0.001Chi-squared
Primary
Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities
Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities | 20.4 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities | 21.6 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities | 26.4 Percentage of participants |
p-value: <0.001Chi-squared
Primary
Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications
Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative).
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications | 59.6 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications | 57.6 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications | 59.8 Percentage of participants |
p-value: 0.835Chi-squared
Secondary
Dosage of Empagliflozin
Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Dosage of Empagliflozin | 10 milligram of empagliflozin | NA Participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Dosage of Empagliflozin | 25 milligram of empagliflozin | NA Participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Dosage of Empagliflozin | 10 milligram of empagliflozin | NA Participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Dosage of Empagliflozin | 25 milligram of empagliflozin | NA Participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Dosage of Empagliflozin | 25 milligram of empagliflozin | NA Participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Dosage of Empagliflozin | 10 milligram of empagliflozin | NA Participants |
Secondary
Duration of Diabetes
Duration of diabetes (time since diagnosis).
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Duration of Diabetes | 10.7 Years | Standard Deviation 7.8 |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Duration of Diabetes | 10.8 Years | Standard Deviation 8.2 |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Duration of Diabetes | 11.2 Years | Standard Deviation 8.5 |
p-value: 0.475Wilcoxon rank sum test
Secondary
Fasting Plasma Glucose (FPG)
Fasting plasma glucose (FPG).
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Fasting Plasma Glucose (FPG) | 186.0 Milligram / deciliter | Standard Deviation 85.6 |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Fasting Plasma Glucose (FPG) | 182.3 Milligram / deciliter | Standard Deviation 76.5 |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Fasting Plasma Glucose (FPG) | 181.1 Milligram / deciliter | Standard Deviation 78.5 |
p-value: 1Wilcoxon rank sum test
Secondary
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c).
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Glycated Hemoglobin (HbA1c) | 65.7 nanomol/mol | Standard Deviation 18.4 |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Glycated Hemoglobin (HbA1c) | 66.6 nanomol/mol | Standard Deviation 18.7 |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Glycated Hemoglobin (HbA1c) | 67.8 nanomol/mol | Standard Deviation 20.4 |
p-value: 0.475Wilcoxon rank sum test
Secondary
Height of Participants
Height of participants.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Height of Participants | 170.5 Centimeter (cm) | Standard Deviation 9.5 |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Height of Participants | 171.8 Centimeter (cm) | Standard Deviation 9.9 |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Height of Participants | 172.3 Centimeter (cm) | Standard Deviation 9.6 |
p-value: <0.001Wilcoxon rank sum test
Secondary
Number of Participants With Hospitalizations
Number of participants with hospitalizations.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Number of Participants With Hospitalizations | NA Participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Number of Participants With Hospitalizations | NA Participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Number of Participants With Hospitalizations | NA Participants |
Secondary
Percentage of Male Participants
The percentage of male participants is reported.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Male Participants | 50.9 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Male Participants | 61.8 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Male Participants | 66.5 Percentage of participants |
p-value: <0.001Chi-squared
Secondary
Percentage of Participants by Age Category
Percentage of participants by age category; younger than 65 (\< 65), from 65 to 74 (65 ≤ 75) , from 75 to 80 (75 - 80) , older than 80 (\> 80).
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants by Age Category | < 65 | 71.1 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants by Age Category | 65 ≤ 75 | 20.0 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants by Age Category | 75 - 80 | 6.5 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants by Age Category | > 80 | 2.4 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants by Age Category | > 80 | 3.6 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants by Age Category | < 65 | 60.8 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants by Age Category | 75 - 80 | 8.3 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants by Age Category | 65 ≤ 75 | 27.4 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants by Age Category | > 80 | 5.4 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants by Age Category | 65 ≤ 75 | 28.9 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants by Age Category | 75 - 80 | 11.3 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants by Age Category | < 65 | 54.4 Percentage of participants |
Comparison: Group: \< 65p-value: <0.001Chi-squared
Comparison: Group: 65 ≤ 75p-value: 0.001Chi-squared
Comparison: Group: 75 - 80p-value: <0.001Chi-squared
Comparison: Group: \> 80p-value: <0.002Chi-squared
Secondary
Percentage of Participants With Previous Glucose-lowering Treatment
Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Glucose-lowering Treatment | Metformin | 60.8 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Glucose-lowering Treatment | Dipeptidyl peptidase-4 (DPP-4) inhibitors | 25.2 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Glucose-lowering Treatment | Sulfonylurea | 9.3 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Glucose-lowering Treatment | Insulin | 34.3 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Glucose-lowering Treatment | Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin | 7.9 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Glucose-lowering Treatment | Glucagon-like peptide-1 (GLP-1) agonists | 12.1 Percentage of participants |
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Participants With Previous Glucose-lowering Treatment | Acarbose | 1.0 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Sulfonylurea | 6.8 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Insulin | 37.2 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Metformin | 59.7 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Acarbose | 0.9 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Dipeptidyl peptidase-4 (DPP-4) inhibitors | 31.1 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Glucagon-like peptide-1 (GLP-1) agonists | 12.2 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin | 2.3 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Dipeptidyl peptidase-4 (DPP-4) inhibitors | 31.8 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Metformin | 68.6 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin | 2.7 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Glucagon-like peptide-1 (GLP-1) agonists | 13.9 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Sulfonylurea | 5.0 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Acarbose | 0.4 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Participants With Previous Glucose-lowering Treatment | Insulin | 49.9 Percentage of participants |
Comparison: Insulinp-value: <0.001Chi-squared
Comparison: Metforminp-value: <0.001Chi-squared
Comparison: Acarbosep-value: 0.157Chi-squared
Comparison: Sulfonylureap-value: <0.001Chi-squared
Comparison: Dipeptidyl peptidase-4 (DPP-4) inhibitorsp-value: 0.071Chi-squared
Comparison: Glucagon-like peptide-1 (GLP-1) agonistsp-value: 0.317Chi-squared
Comparison: Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozinp-value: <0.001Chi-squared
Secondary
Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes
Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes | 53.5 Percentage of participants |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes | 48.6 Percentage of participants |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes | 31.8 Percentage of participants |
p-value: <0.002Chi-squared
Secondary
Weight of Participants
Weight of participants.
Time frame: At baseline.
Population: All patients from the two largest German registries (Diabetes-Patienten-Verlaufs-Dokumentation and Diabetes Versorgungs-Evaluation) with Type-2 Diabetes Mellitus and with empagliflozin treatment were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Users: Patients Receiving Empagliflozin Until Mid-September 2015 | Weight of Participants | 103.2 Kilogram (kg) | Standard Deviation 21.4 |
| Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017 | Weight of Participants | 100.3 Kilogram (kg) | Standard Deviation 23.1 |
| Late Users: Patients Receiving Empagliflozin After Mid-January 2017 | Weight of Participants | 97.3 Kilogram (kg) | Standard Deviation 21.7 |
p-value: <0.001Wilcoxon rank sum test