Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03817463
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multi-country Non-interventional Study on the Effectiveness of Empagliflozin in Adult Patients With Type 2 Diabetes in Europe and Asia.
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with T2DM Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor

Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
Dipeptidyl peptidase-4 (DPP-4) inhibitor




Primary Outcome Measures :
  1. Number of subjects hospitalized for heart failure [ Time Frame: up to 4.5 years ]
  2. Numbers of subjects with all-cause mortality [ Time Frame: up to 4.5 years ]
  3. Number of subjects with both hospitalization for heart failure and all cause mortality [ Time Frame: up to 4.5 years ]
  4. Number of subjects with myocardial infraction (MI), stroke, all cause mortality [ Time Frame: up to 4.5 years ]

Secondary Outcome Measures :
  1. Number of subjects with Cardiovascular mortality [ Time Frame: up to 4.5 years ]
  2. Number of subjects to risk of a composite outcome including hospitalization for heart failure and cardiovascular (CV) mortality [ Time Frame: up to 4.5 years ]
  3. Number of subjects with 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI),stroke, and cardiovascular (CV) mortality [ Time Frame: up to 4.5 years ]
  4. Number of subjects with coronary revascularization procedure [ Time Frame: up to 4.5 years ]
  5. Number of subjects with end-stage renal disease (ESRD) [ Time Frame: up to 4.5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This will be a non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of T2DM. All data will be obtained from electronically recorded longitudinal secondary data sources, separately in each included country. In each country, patients initiating treatment with empagliflozin or any other SGLT-2 inhibitor will be compared with PS-matched patients initiating treatment with any DPP-4inhibitor.
Criteria

Inclusion Criteria:

  • Dispensation or prescription of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor during the study period
  • No dispensation or prescription of any other SGLT-2 inhibitor or DPP-4 inhibitor1 during the preceding 12 months including at index date, and
  • Having a diagnosis of T2DM before index date, based on ICD-10 codes or other available data

Exclusion Criteria:

  • Aged <18 years on the first dispensation or prescription date of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor
  • Having a diagnosis of ESRD during the 12 months before the index date
  • <12 months of available data before the index date, and/or no complete drug dispensation /prescription history during this period
  • Missing or ambiguous data on age or gender

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): NCT03817463


Contacts
Layout table for location contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Sponsors and Collaborators
Boehringer Ingelheim

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03817463     History of Changes
Other Study ID Numbers: 1245-0195
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 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'.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Dipeptidyl-Peptidase IV Inhibitors
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors