N/A
Completed N=9,571
A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes
Source: ClinicalTrials.gov NCT04098575 ↗Enrolled (actual)
9,571
Serious AEs
—
Results posted
Mar 2021
Primary outcomePrimary: Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities — 20.4; 21.6; 26.4 Percentage of participants — p=<0.001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities |
20.4; 21.6; 26.4 | <0.001 sig |
| PRIMARY Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications |
59.6; 57.6; 59.8 | 0.835 |
| PRIMARY Percentage of Participants With Antidiabetic and Cardiovascular Co-medication |
45.4; 49.5; 59.8; 28.3; 36.4; 46.0 | <0.001 sig |
| SECONDARY Percentage of Participants by Age Category |
71.1; 60.8; 54.4; 20.0; 27.4; 28.9 | <0.001 sig |
| SECONDARY Percentage of Male Participants |
50.9; 61.8; 66.5 | <0.001 sig |
| SECONDARY Weight of Participants |
103.2; 100.3; 97.3 | <0.001 sig |
| SECONDARY Height of Participants |
170.5; 171.8; 172.3 | <0.001 sig |
| SECONDARY Glycated Hemoglobin (HbA1c) |
65.7; 66.6; 67.8 | 0.475 |
| SECONDARY Duration of Diabetes |
10.7; 10.8; 11.2 | 0.475 |
| SECONDARY Percentage of Participants With Previous Glucose-lowering Treatment |
34.3; 37.2; 49.9; 60.8; 59.7; 68.6 | <0.001 sig |
| SECONDARY Percentage of Patients Participated in Disease Management Programme (DMP) Type 2 Diabetes |
53.5; 48.6; 31.8 | <0.002 sig |
| SECONDARY Number of Participants With Hospitalizations |
NA; NA; NA | — |
| SECONDARY Dosage of Empagliflozin |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Fasting Plasma Glucose (FPG) |
186.0; 182.3; 181.1 | 1.000 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04098575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.