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OpenTrials
Completed

NCT Number: NCT02843399

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

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research site

Wilmington, Delaware, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Aged 18 or older as of the index date.
  • 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.)
  • 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

  • No outpatient prescription claims for any injectable glucose-lowering medication during the baseline period (GLP-1RA or insulins).
  • 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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Truven health

Registry information

Official study title

Clinical and Economic Outcomes of Patients With Type 2 Diabetes Mellitus Initiating Bydureon and Glargine

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2016
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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