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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02843399

Enrollment

15498

Registered

2016-07-25

Start date

2016-08-15

Completion date

2016-12-15

Last updated

2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall HCRU/Costs	Up to 12 Months	To compare overall healthcare utilization and costs in patients initiating EQW (Exenatide Once Weekly) vs. IG (Insulin Glargine)
MACE-related HCRU/Costs	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)
Medical Hypoglycemic events	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

Measure	Time frame	Description
Composite of A1C <7%/no weight gain/no hypoglycemia	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.

Countries

United States

Outcome results