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Comparative Effectiveness of Empagliflozin in the US

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ClinicalTrials.gov Identifier: NCT03363464
Recruitment Status : Active, not recruiting
First Posted : December 6, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with several previous cardiovascular outcomes trials, which failed to demonstrate an association with a higher or a lower risk of cardiovascular outcomes associated with members of other recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause mortality.However, these and other findings arising from an extensive clinical trial program aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be demonstrated in a non-trial environment. This study aims to investigate the transferability of the effects demonstrated in dedicated randomized clinical studies to a broader population under real world conditions.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Empagliflozin Drug: DPP-4 inhibitor

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Study Type : Observational
Actual Enrollment : 80000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Study on the Effectiveness and Safety of Empagliflozin Compared With DPP-4 Inhibitors in Patients With Type 2 Diabetes in the United States
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : November 15, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with T2DM initiating empagliflozin
Type 2 diabetes mellitus
Drug: Empagliflozin
Empagliflozin
Other Name: JARDIANCE, JARDIANZ, GIBTULIO

patients with T2DM initiating a DPP-4 inhibitor
dipeptidyl peptidase-4 inhibitor treated patients
Drug: DPP-4 inhibitor
dipeptidyl peptidase-4 inhibitor




Primary Outcome Measures :
  1. 3-point MACE [hospital admission for MI, hospital admission for stroke, CV mortality] and its individual components [ Time Frame: 60 months ]

    MACE-major adverse cardiovascular events

    MI- acute myocardial infarction CV- cardiovascular


  2. the rate of hospital admission for Heart failure [ Time Frame: 60 months ]
  3. all-cause mortality [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. Number of participants with coronary revascularization procedure [ Time Frame: 60 months ]
  2. Number of participants with Bone fracture [ Time Frame: 60 months ]
  3. Number of participants with End-stage renal disease (ESRD) [ Time Frame: 60 months ]
  4. Number of participants for laser treatment of retinopathy [ Time Frame: 60 months ]
  5. Number of participants with DKA [ Time Frame: 60 months ]
    DKA- diabetic ketoacidosis

  6. Number of participants with severe Hypoglycemia [ Time Frame: 60 months ]
  7. Number of participants with Urinary tract cancers [ Time Frame: 60 months ]
  8. Number of participants with lower-limb amputation [ Time Frame: 60 months ]
  9. Number of participants with acute kidney injury requiring dialysis [ Time Frame: 60 months ]


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
T2DM eligible patients in Medicare fee for service, plans A, B, D; United Healthcare (Optum Clinformatics Data Mart); MarketScan (Truven Healthcare Analytics)
Criteria

Inclusion criteria:

  • Patients >= 18 years old
  • Patients initiating empagliflozin or a DPP-4 inhibitor (sitagliptin, saxagliptin,linagliptin, alogliptin) within the study period. Initiation will be defined as no use of SGLT-2 inhibitors or DPP-4 inhibitors in the previous 12 months
  • restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation

Exclusion criteria:

  • Patients with missing or ambiguous age or sex information
  • All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded
  • Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient ICD-9 Dx code of 250.x1 or 250.x3 or ICD-10 Dx code of E10.x in the 12 months prior to drug initiation
  • Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation
  • History of cancer in the 5 years prior to drug initiation
  • End-stage renal disease (ESRD) in the 12 months prior to drug initiation
  • HIV diagnosis or treatment in the 12 months prior to drug initiation
  • Organ transplant in the 12 months prior to drug initiation
  • Patients that were in nursing homes in the 12 months prior to drug initiation
  • Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded

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): NCT03363464


Locations
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United States, Massachusetts
Bringham Women Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Boehringer Ingelheim
Eli Lilly and Company
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03363464     History of Changes
Other Study ID Numbers: 1245.92
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
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