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

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ClinicalTrials.gov Identifier: NCT04098575
Recruitment Status : Active, not recruiting
First Posted : September 23, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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 Empa-gliflozin in three time intervals

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Empagliflozin

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Study Type : Observational
Actual Enrollment : 7900 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 : September 16, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Percentage of previous occurance of cardiovascular comorbidities [ Time Frame: Up to 2 years ]
    Myocardial infarction (MI), Stroke, Coronary artery disease (CAD), Peripheral artery disease (PAD), CHF

  2. Percentage of Diabetes complications [ Time Frame: Up to 2 years ]
    Neuropathy, Nephropathy / Renal function (eGFR, micro-/ macroalbuminuria), Diabetic foot syndrome, Retinopathy (background and proliferative)

  3. Percentage of Antidiabetic and cardiovascular co-medication [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Number of subjects with age [ Time Frame: Up to 2 years ]
    <65; 65 - <75; 75 - 80 , >80

  2. Baseline characteristics: gender [ Time Frame: Up to 2 years ]
  3. Baseline characteristics: Weight [ Time Frame: Uop to 2 years ]
  4. Baseline characteristics: height [ Time Frame: Up to 2 years ]
  5. Baseline characteristics: HbA1c [ Time Frame: Up to 2 years ]
  6. Duration of diabetes (Time Since Diagnosis) [ Time Frame: Up to 2 years ]
  7. Number of subjects with previous glucose-lowering treatmen [ Time Frame: Up to 2 years ]
  8. Number of subjects with 10mg and 25mg dosage of empagliflozin [ Time Frame: Up to 2 years ]
  9. Number of subjects participated in Disease Management Programme (DMP) Type 2 Diabetes (from DPV registry) [ Time Frame: Up to 2 years ]
    from DPV registry

  10. Number of subjects with hospitalizations [ Time Frame: Up to 2 years ]
    from DPV registry



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Diabetes Mellitus, Type 2, treated with Empagliflozin
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098575


Locations
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Germany
Diabetes Agenda 2010 GmbH
Mahlow, Germany, 15831
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04098575     History of Changes
Other Study ID Numbers: 1245-0198
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. Studies in products where Boehringer Ingelheim is not the license holder
  2. Studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials
  3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

Requestors can use the following link http://trials.boehringer-ingelheim.com/


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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:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs