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DIA_CENTRAL:T2D Treatment Pattern in Central Europe

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ClinicalTrials.gov Identifier: NCT03807440
Recruitment Status : Not yet recruiting
First Posted : January 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This is a cross sectional, non-interventional study using existing data including medical chart review.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Empagliflozin Drug: Sodium Glucose Transporter 2 inhibitor Drug: Dipeptidyl-peptidase 4 inhibitor Drug: Glucagon-like peptide 1 agonist

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: CORDIALLY® - CEE: Characteristics of Patients With Type 2 Diabetes Treated With Modern Antidiabetic Drugs. A Real World Data Collection of Patient Baseline Characteristics, Treatment Patterns and Comorbidities in Central Eastern European (CEE) Countries
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Subjects with Diabetes Mellitus, Type 2 Drug: Empagliflozin
Empagliflozin
Other Name: Jardiance® Synjardy® Trajenta® Jentadueto®

Drug: Sodium Glucose Transporter 2 inhibitor
Sodium Glucose Transporter 2 inhibitor
Other Name: Jardiance® Synjardy® Trajenta® Jentadueto®

Drug: Dipeptidyl-peptidase 4 inhibitor
Dipeptidyl-peptidase 4 inhibitor
Other Name: Jardiance® Synjardy® Trajenta® Jentadueto®

Drug: Glucagon-like peptide 1 agonist
Glucagon-like peptide 1 agonist
Other Name: Jardiance® Synjardy® Trajenta® Jentadueto®




Primary Outcome Measures :
  1. measurement of T2D patient demographics [ Time Frame: at baseline ]

Secondary Outcome Measures :
  1. Prevalence of Cardiovascular disease in T2D patient population [ Time Frame: up to 2 years ]
  2. Prevalence of chronic kidney disease in T2D patient population [ Time Frame: up to 2 years ]
  3. Prevalence of cardiovascular disease/Chronic kidney disease in T2D patient population [ Time Frame: up to 2 years ]
  4. number of participants with cardiovascular disease at study index date [ Time Frame: up to 2 years ]
  5. measurement of treatment decisions with employment status [ Time Frame: upto 2 years ]
  6. measurement of treatment decisions with family status [ Time Frame: up to 2 years ]
  7. measurement of treatment decisions with type of health insurance [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (18 years of age or older) with Type 2 Diabetes diagnosis, naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), DPP4i (Dipeptidyl-peptidase 4 inhibitor) or GLP1a (Glucagon-like peptide 1 agonist) at index date were chosen.
Criteria

Inclusion Criteria:

  1. Written informed consent prior to participation
  2. Female and male patients age ≥ 18 years
  3. Patients with T2D diagnosis
  4. Patients who are newly initiated (first ever use) with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) in September 2018 (study index date)
  5. Patients are naïve to treatment with empagliflozin or other Sodium Glucose Transporter 2 inhibitor (SGLT2i), Dipeptidyl-peptidase 4 inhibitor (DPP4i) or Glucagon-like peptide 1 agonist (GLP1a) at study index date

Exclusion Criteria:

  1. Patients age < 18 years
  2. Patients with diagnosis of other types of diabetes than T2D
  3. Patients who do not provide written consent to the terms of the study

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): NCT03807440


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Alexey Medvedchikov, +43180105-7896 Alexey.Medvedchikov@Boehringer-Ingelheim.com

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03807440     History of Changes
Other Study ID Numbers: 1245-0187
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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/ to:

  1. Find information in order to request access to clinical study data, for listed studies.
  2. Request access to clinical study documents that meet criteria, and upon a signed' document sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Linagliptin
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Dipeptidyl-Peptidase IV Inhibitors
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Protease Inhibitors
Enzyme Inhibitors