EDCOS: A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT04098575
Collaborator
(none)
9,571
1
3.5
2748.3
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
9571 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Treatment of T2DM Patients in Germany Receiving Empagliflozin: A Retrospective RWE Study Description of Treatment and Population Characteristics of Type 2 Diabetic Patients in Germany Receiving Empagliflozin: A Retrospective Real-World Evidence (RWE) Study Based on German Registries DPV&DIVE
Actual Study Start Date
:
Sep 16, 2019
Actual Primary Completion Date
:
Dec 31, 2019
Actual Study Completion Date
:
Dec 31, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients receiving Empagliflozin until mid Sep 2015 Patients receiving Empagliflozin before the EMPA-REG-OUTCOME study was published time until mid-Sept. 2015; Cohort 1 |
Drug: Empagliflozin
drug
|
| Patients receiving Empagliflozin until CV Label Change time Patients receiving Empagliflozin starting from the EMPA-REG-OUTCOME study being published until CV Label Change time from mid-Sept. 2015-mid-Jan. 2017; Cohort 2 |
Drug: Empagliflozin
drug
|
| Patients receiving Empagliflozin until last available data cut Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3 |
Drug: Empagliflozin
drug
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
- Percentage of Male Participants [At baseline.]
The percentage of male participants is reported.
- Weight of Participants [At baseline.]
Weight of participants.
- 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 Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes [At baseline.]
Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes.
- 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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Diabetes Agenda 2010 GmbH | Mahlow | Germany | 15831 |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
None specified.Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04098575
Other Study ID Numbers:
- 1245-0198
First Posted:
Sep 23, 2019
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Study Results
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 Detail | 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. |
| Arm/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Period Title: Overall Study | |||
| STARTED | 505 | 2961 | 6105 |
| COMPLETED | 505 | 2961 | 6105 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | 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 |
|---|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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 of all reporting groups |
| Overall Participants | 505 | 2961 | 6105 | 9571 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
59.2
(11.3)
|
61.2
(11.5)
|
63.2
(11.4)
|
62.4
(11.5)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
248
49.1%
|
1131
38.2%
|
2045
33.5%
|
3424
35.8%
|
| Male |
257
50.9%
|
1830
61.8%
|
4060
66.5%
|
6147
64.2%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||
| Count of Participants [Participants] |
0
0%
|
|||
Outcome Measures
| Title | Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Number [Percentage of participants] |
20.4
4%
|
21.6
0.7%
|
26.4
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Number [Percentage of participants] |
59.6
11.8%
|
57.6
1.9%
|
59.8
1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.835 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants With Antidiabetic and Cardiovascular Co-medication |
|---|---|
| Description | Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Antihypertensive drugs |
45.4
9%
|
49.5
1.7%
|
59.8
1%
|
| Lipid-lowering agents |
28.3
5.6%
|
36.4
1.2%
|
46.0
0.8%
|
| Antplatelet, anticoagulant drugs |
11.7
2.3%
|
17.4
0.6%
|
25.3
0.4%
|
| Glucose-lowering therapies |
80.2
15.9%
|
83.1
2.8%
|
90.6
1.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Antihypertensive drugs | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Lipid-lowering agents | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Antiplatelet, anticoagulant drugs | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Glucose-lowering therapies | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants by Age Category |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| < 65 |
71.1
14.1%
|
60.8
2.1%
|
54.4
0.9%
|
| 65 ≤ 75 |
20.0
4%
|
27.4
0.9%
|
28.9
0.5%
|
| 75 - 80 |
6.5
1.3%
|
8.3
0.3%
|
11.3
0.2%
|
| > 80 |
2.4
0.5%
|
3.6
0.1%
|
5.4
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Group: < 65 | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Group: 65 ≤ 75 | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Group: 75 - 80 | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Group: > 80 | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.002 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Male Participants |
|---|---|
| Description | The percentage of male participants is reported. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Number [Percentage of participants] |
50.9
10.1%
|
61.8
2.1%
|
66.5
1.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Weight of Participants |
|---|---|
| Description | Weight of participants. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Mean (Standard Deviation) [Kilogram (kg)] |
103.2
(21.4)
|
100.3
(23.1)
|
97.3
(21.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Title | Height of Participants |
|---|---|
| Description | Height of participants. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Mean (Standard Deviation) [Centimeter (cm)] |
170.5
(9.5)
|
171.8
(9.9)
|
172.3
(9.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Title | Glycated Hemoglobin (HbA1c) |
|---|---|
| Description | Glycated hemoglobin (HbA1c). |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Mean (Standard Deviation) [nanomol/mol] |
65.7
(18.4)
|
66.6
(18.7)
|
67.8
(20.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.475 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Title | Duration of Diabetes |
|---|---|
| Description | Duration of diabetes (time since diagnosis). |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Mean (Standard Deviation) [Years] |
10.7
(7.8)
|
10.8
(8.2)
|
11.2
(8.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.475 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Title | Percentage of Participants With Previous Glucose-lowering Treatment |
|---|---|
| Description | Percentage of participants with glucose-lowering treatment prior to empagliflozin initiation. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Insulin |
34.3
6.8%
|
37.2
1.3%
|
49.9
0.8%
|
| Metformin |
60.8
12%
|
59.7
2%
|
68.6
1.1%
|
| Acarbose |
1.0
0.2%
|
0.9
0%
|
0.4
0%
|
| Sulfonylurea |
9.3
1.8%
|
6.8
0.2%
|
5.0
0.1%
|
| Dipeptidyl peptidase-4 (DPP-4) inhibitors |
25.2
5%
|
31.1
1.1%
|
31.8
0.5%
|
| Glucagon-like peptide-1 (GLP-1) agonists |
12.1
2.4%
|
12.2
0.4%
|
13.9
0.2%
|
| Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin |
7.9
1.6%
|
2.3
0.1%
|
2.7
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Insulin | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Metformin | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Acarbose | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.157 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Sulfonylurea | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Dipeptidyl peptidase-4 (DPP-4) inhibitors | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.071 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Glucagon-like peptide-1 (GLP-1) agonists | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.317 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | Sodium-glucose transport protein-2 (SGLT2) inhibitors other than empagliflozin | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes |
|---|---|
| Description | Percentage of patients participated in Disease Management Programme (DMP) Type 2 Diabetes. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Number [Percentage of participants] |
53.5
10.6%
|
48.6
1.6%
|
31.8
0.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.002 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants With Hospitalizations |
|---|---|
| Description | Number of participants with hospitalizations. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Number [Participants] |
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Title | Dosage of Empagliflozin |
|---|---|
| Description | Dosage of empagliflozin. Number of patients on 10 milligram versus patients on 25 milligram empagliflozin. |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| 10 milligram of empagliflozin |
NA
NaN
|
NA
NaN
|
NA
NaN
|
| 25 milligram of empagliflozin |
NA
NaN
|
NA
NaN
|
NA
NaN
|
| Title | Fasting Plasma Glucose (FPG) |
|---|---|
| Description | Fasting plasma glucose (FPG). |
| Time Frame | At baseline. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | 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 |
|---|---|---|---|
| Arm/Group Description | 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. | 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). | 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. |
| Measure Participants | 505 | 2961 | 6105 |
| Mean (Standard Deviation) [Milligram / deciliter] |
186.0
(85.6)
|
182.3
(76.5)
|
181.1
(78.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 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 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | As this is a non-interventional study with secondary use of data retrieved from a US health claims database, safety monitoring and safety reporting on an individual case level is not applicable. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed". | |||||
| Arm/Group Title | 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 | |||
| Arm/Group Description | 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. | 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). | 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. | |||
All Cause Mortality |
||||||
| 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 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
| 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 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
| 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 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Limitations/Caveats
The main limitation of the study is that patients were recruited from specialized centers that were participating in diabetes registries, which could bias the results toward patients requiring specialist care. The cross-sectional nature of the study precludes the identification of causal links between findings.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Boehringer Ingelheim, Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT04098575
Other Study ID Numbers:
- 1245-0198
First Posted:
Sep 23, 2019
Last Update Posted:
Mar 29, 2021
Last Verified:
Mar 1, 2021