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

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus Type 2

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exenatide once weekly (EQW)<br>EQW cohort includes patients with one or more outpatient prescription claims for EQW between 2012 and 2015. | |
| Insulin Glargine (IG)<br>IG cohort includes patients with one or more outpatient prescription claims for IG between 2012 and 2015 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes-related HCRU/costs | Compare diabetes-related healthcare utilization and costs in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall HCRU/Costs | To compare overall healthcare utilization and costs in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) | Up to 12 Months | 
| MACE-related HCRU/Costs | To compare major adverse cardiovascular event (MACE)-related healthcare utilization and costs in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) | Up to 12 Months | 
| Medical Hypoglycemic events | To compare rates and costs of medically attended hypoglycemia in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine) | Up to 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus Type 2