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Economic Outcomes of EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) in T2D Patients Who Are New to Injectable Therapy

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ClinicalTrials.gov Identifier: NCT02843399
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Truven health
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
Primary objective of this study is to compare diabetes-related healthcare utilization and costs in patients initiating exenatide once weekly vs insulin glargine.

Condition or disease
Diabetes Mellitus Type 2

Detailed Description:
This retrospective, observational cohort analysis will assess medical and pharmacy claims for adult patients with type 2 diabetes from the Truven Health MarketScan® Commercial and Medicare Supplemental claims databases between 2011 and 2015. Diabetes-related healthcare utilization and costs will be measured as a primary outcome. Secondary outcomes include all-cause healthcare utilization and costs, major adverse cardiovascular event (MACE)-related utilization and costs, and medically attended hypoglycemia events.

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Study Type : Observational
Actual Enrollment : 15498 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical and Economic Outcomes of Patients With Type 2 Diabetes Mellitus Initiating Bydureon and Glargine
Actual Study Start Date : August 15, 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Exenatide once weekly (EQW)
EQW cohort includes patients with one or more outpatient prescription claims for EQW between 2012 and 2015.
Insulin Glargine (IG)
IG cohort includes patients with one or more outpatient prescription claims for IG between 2012 and 2015



Primary Outcome Measures :
  1. Diabetes-related HCRU/costs [ Time Frame: Up to 12 months ]
    Compare diabetes-related healthcare utilization and costs in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine)


Secondary Outcome Measures :
  1. Overall HCRU/Costs [ Time Frame: Up to 12 Months ]
    To compare overall healthcare utilization and costs in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine)

  2. MACE-related HCRU/Costs [ Time Frame: Up to 12 Months ]
    To compare major adverse cardiovascular event (MACE)-related healthcare utilization and costs in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine)

  3. Medical Hypoglycemic events [ Time Frame: Up to 12 Months ]
    To compare rates and costs of medically attended hypoglycemia in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine)


Other Outcome Measures:
  1. Composite of A1C <7%/no weight gain/no hypoglycemia [ Time Frame: Up to 12 Months ]
    The exploratory objective of this analysis is to compare attainment of a composite endpoint, and attainment of each of the individual components thereof separately, comprising an HbA1c less than 7%, no weight gain, and no hypoglycemia in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine). This will be conducted among a subset of patients with available laboratory data.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Commercial Insurance
Criteria

Inclusion Criteria:

  1. One or more outpatient prescription claim for EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) between February 1, 2012, and June 30, 2014 (date of first claim = index date; medication to which first claim corresponds = index therapy).
  2. Aged 18 or older as of the index date.
  3. Continuous enrollment in medical and pharmacy benefits for 12 months before (baseline period) and 12 months after (follow-up period) the index date. (6 months follow-up will be provided to determine the effect on sample size.)
  4. One or more medical claims with a diagnosis code for T2DM (ICD-9-CM 250.x0 or 250.x2) in the baseline period or on the index date.

Exclusion Criteria:

  1. No outpatient prescription claims for any injectable glucose-lowering medication during the baseline period (GLP-1RA or insulins).
  2. No medical claims with a diagnosis (or procedure, where appropriate) code indicative for type 1 diabetes mellitus (ICD-9-CM 250.x1 or 250.x3), gestational diabetes (ICD-9-CM 648.8x), or pregnancy or childbirth in the baseline or follow-up periods.

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): NCT02843399


Locations
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United States, Delaware
Research site
Wilmington, Delaware, United States
Sponsors and Collaborators
AstraZeneca
Truven health
Investigators
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Study Director: Eric T. Wittbrodt, PharmD, MPH AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02843399    
Other Study ID Numbers: D5551R00012
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Keywords provided by AstraZeneca:
Diabetes Mellitus Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases