Trial Outcomes & Findings for A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes (NCT NCT04098575)
NCT ID: NCT04098575
Last Updated: 2021-03-29
Results Overview
Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.
Recruitment status
COMPLETED
Target enrollment
9571 participants
Primary outcome timeframe
At baseline.
Results posted on
2021-03-29
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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).
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
505
|
2961
|
6105
|
|
Overall Study
COMPLETED
|
505
|
2961
|
6105
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
Total
n=9571 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.2 Years
STANDARD_DEVIATION 11.3 • n=505 Participants
|
61.2 Years
STANDARD_DEVIATION 11.5 • n=2961 Participants
|
63.2 Years
STANDARD_DEVIATION 11.4 • n=6105 Participants
|
62.4 Years
STANDARD_DEVIATION 11.5 • n=9571 Participants
|
|
Sex: Female, Male
Female
|
248 Participants
n=505 Participants
|
1131 Participants
n=2961 Participants
|
2045 Participants
n=6105 Participants
|
3424 Participants
n=9571 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=505 Participants
|
1830 Participants
n=2961 Participants
|
4060 Participants
n=6105 Participants
|
6147 Participants
n=9571 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities
|
20.4 Percentage of participants
|
21.6 Percentage of participants
|
26.4 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications
|
59.6 Percentage of participants
|
57.6 Percentage of participants
|
59.8 Percentage of participants
|
PRIMARY outcome
Timeframe: 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.
Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
Antplatelet, anticoagulant drugs
|
11.7 Percentage of participants
|
17.4 Percentage of participants
|
25.3 Percentage of participants
|
|
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
Glucose-lowering therapies
|
80.2 Percentage of participants
|
83.1 Percentage of participants
|
90.6 Percentage of participants
|
|
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
Antihypertensive drugs
|
45.4 Percentage of participants
|
49.5 Percentage of participants
|
59.8 Percentage of participants
|
|
Percentage of Participants With Antidiabetic and Cardiovascular Co-medication
Lipid-lowering agents
|
28.3 Percentage of participants
|
36.4 Percentage of participants
|
46.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants by Age Category
< 65
|
71.1 Percentage of participants
|
60.8 Percentage of participants
|
54.4 Percentage of participants
|
|
Percentage of Participants by Age Category
65 ≤ 75
|
20.0 Percentage of participants
|
27.4 Percentage of participants
|
28.9 Percentage of participants
|
|
Percentage of Participants by Age Category
75 - 80
|
6.5 Percentage of participants
|
8.3 Percentage of participants
|
11.3 Percentage of participants
|
|
Percentage of Participants by Age Category
> 80
|
2.4 Percentage of participants
|
3.6 Percentage of participants
|
5.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
The percentage of male participants is reported.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Percentage of Male Participants
|
50.9 Percentage of participants
|
61.8 Percentage of participants
|
66.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Weight of participants.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Weight of Participants
|
103.2 Kilogram (kg)
Standard Deviation 21.4
|
100.3 Kilogram (kg)
Standard Deviation 23.1
|
97.3 Kilogram (kg)
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 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.
Height of participants.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Height of Participants
|
170.5 Centimeter (cm)
Standard Deviation 9.5
|
171.8 Centimeter (cm)
Standard Deviation 9.9
|
172.3 Centimeter (cm)
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: 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.
Glycated hemoglobin (HbA1c).
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Glycated Hemoglobin (HbA1c)
|
65.7 nanomol/mol
Standard Deviation 18.4
|
66.6 nanomol/mol
Standard Deviation 18.7
|
67.8 nanomol/mol
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: 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.
Duration of diabetes (time since diagnosis).
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Duration of Diabetes
|
10.7 Years
Standard Deviation 7.8
|
10.8 Years
Standard Deviation 8.2
|
11.2 Years
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 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.
Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Previous Glucose-lowering Treatment
Acarbose
|
1.0 Percentage of participants
|
0.9 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of Participants With Previous Glucose-lowering Treatment
Sulfonylurea
|
9.3 Percentage of participants
|
6.8 Percentage of participants
|
5.0 Percentage of participants
|
|
Percentage of Participants With Previous Glucose-lowering Treatment
Glucagon-like peptide-1 (GLP-1) agonists
|
12.1 Percentage of participants
|
12.2 Percentage of participants
|
13.9 Percentage of participants
|
|
Percentage of Participants With Previous Glucose-lowering Treatment
Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin
|
7.9 Percentage of participants
|
2.3 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Participants With Previous Glucose-lowering Treatment
Insulin
|
34.3 Percentage of participants
|
37.2 Percentage of participants
|
49.9 Percentage of participants
|
|
Percentage of Participants With Previous Glucose-lowering Treatment
Metformin
|
60.8 Percentage of participants
|
59.7 Percentage of participants
|
68.6 Percentage of participants
|
|
Percentage of Participants With Previous Glucose-lowering Treatment
Dipeptidyl peptidase-4 (DPP-4) inhibitors
|
25.2 Percentage of participants
|
31.1 Percentage of participants
|
31.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes
|
53.5 Percentage of participants
|
48.6 Percentage of participants
|
31.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
Number of participants with hospitalizations.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Hospitalizations
|
NA Participants
Data on hospitalizations were not included on the registries, thus no data were available for analysis.
|
NA Participants
Data on hospitalizations were not included on the registries, thus no data were available for analysis.
|
NA Participants
Data on hospitalizations were not included on the registries, thus no data were available for analysis.
|
SECONDARY outcome
Timeframe: 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.
Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin.
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Dosage of Empagliflozin
10 milligram of empagliflozin
|
NA Participants
Data on dosage of empagliflozin were not included on the registries, thus no data were available for analysis.
|
NA Participants
Data on dosage of empagliflozin were not included on the registries, thus no data were available for analysis.
|
NA Participants
Data on dosage of empagliflozin were not included on the registries, thus no data were available for analysis.
|
|
Dosage of Empagliflozin
25 milligram of empagliflozin
|
NA Participants
Data on dosage of empagliflozin were not included on the registries, thus no data were available for analysis.
|
NA Participants
Data on dosage of empagliflozin were not included on the registries, thus no data were available for analysis.
|
NA Participants
Data on dosage of empagliflozin were not included on the registries, thus no data were available for analysis.
|
SECONDARY outcome
Timeframe: 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.
Fasting plasma glucose (FPG).
Outcome measures
| Measure |
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
n=505 Participants
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.
|
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
n=2961 Participants
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).
|
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
n=6105 Participants
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.
|
|---|---|---|---|
|
Fasting Plasma Glucose (FPG)
|
186.0 Milligram / deciliter
Standard Deviation 85.6
|
182.3 Milligram / deciliter
Standard Deviation 76.5
|
181.1 Milligram / deciliter
Standard Deviation 78.5
|
Adverse Events
Early Users: Patients Receiving Empagliflozin Until Mid-September 2015
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermediate Users: Patients Receiving Empagliflozin From Mid-September 2015 to Mid-January 2017
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late Users: Patients Receiving Empagliflozin After Mid-January 2017
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER