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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843399
• Other study ID #: D5551R00012
• Status: Completed
• Phase: N/A
• First received: July 21, 2016
• Last updated: December 14, 2017
• Start date: August 15, 2016
• Est. completion date: December 15, 2016

Study information

• Verified date: December 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15498
• Est. completion date: December 15, 2016
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	Research site	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Truven health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite of A1C <7%/no weight gain/no hypoglycemia	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.	Up to 12 Months
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Synopsis_D5551R00012