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

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

Sponsors

Lead sponsor: AstraZeneca

Collaborator: Truven health

Source 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.

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.

Overall Status Completed
Start Date August 15, 2016
Completion Date December 15, 2016
Primary Completion Date December 15, 2016
Study Type Observational
Primary Outcome
Measure Time Frame
Diabetes-related HCRU/costs Up to 12 months
Secondary Outcome
Measure Time Frame
Overall HCRU/Costs Up to 12 Months
MACE-related HCRU/Costs Up to 12 Months
Medical Hypoglycemic events Up to 12 Months
Enrollment 15498
Condition
Eligibility

Sampling method: Non-Probability Sample

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.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Eric T. Wittbrodt, PharmD, MPH Study Director AstraZeneca
Location
facility Research site
Location Countries

United States

Verification Date

December 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Exenatide once weekly (EQW)

Description: EQW cohort includes patients with one or more outpatient prescription claims for EQW between 2012 and 2015.

Arm group label: Insulin Glargine (IG)

Description: IG cohort includes patients with one or more outpatient prescription claims for IG between 2012 and 2015

Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov