A Study Based on Data From German Registries That Looks at Characteristics of People Who Take the Medicine Empagliflozin for Type 2 Diabetes

NCT04098575 | Completed Results FDA Drug

• 1 other identifier: 1245-0198
• Study Type: observational
• Target: 9,571
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Previous Occurence of Cardiovascular Comorbidities

  Percentage of patients with previous occurence of cardiovascular (CV) comorbidities, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, congestive heart failure.

  At baseline.

• Percentage of Participants With Previous Occurence of Other Typical Diabetes Complications

  Percentage of participants with previous occurence of other typical diabetes complications, including, Neuropathy, Nephropathy, Chronic Kidney Disease, Microalbuminuria, Macroalbuminuria, estimated glomerular filtration rate (eGFR), diabetic foot syndrome, retinopathy (background and proliferative).

  At baseline.

• Percentage of Participants With Antidiabetic and Cardiovascular Co-medication

  Percentage of participants with antidiabetic and cardiovascular co-medication, including lipid-lowering agents, other antihypertensives, antiplatelets and anticoagulants.

  At baseline.

Secondary Outcomes (11)

• Percentage of Participants by Age Category

  At baseline.

• Percentage of Male Participants

  At baseline.

• Weight of Participants

  At baseline.

• Height of Participants

  At baseline.

• Glycated Hemoglobin (HbA1c)

  At baseline.

Study Arms (3)

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

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

Patients receiving Empagliflozin until last available data cut

Patients receiving Empagliflozin starting from mid-Jan. 2017 until last; Cohort 3

Drug: Empagliflozin

Interventions

Empagliflozin DRUG

drug

Patients receiving Empagliflozin until CV Label Change time; Patients receiving Empagliflozin until last available data cut; Patients receiving Empagliflozin until mid Sep 2015

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin

You may qualify if:

• 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)

You may not qualify if:

• Any diagnosis of T1DM

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Diabetes Agenda 2010 GmbH

Mahlow, 15831, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and 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.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: September 16, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 29, 2021
• Results First Posted: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)