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

NCT02843399 | Completed

• 1 other identifier: D5551R00012
• Study Type: observational
• Target: 15,498
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall HCRU/Costs

  Up to 12 Months

• MACE-related HCRU/Costs

  Up to 12 Months

• Medical Hypoglycemic events

  Up to 12 Months

Other Outcomes (1)

• Composite of A1C <7%/no weight gain/no hypoglycemia

  Up to 12 Months

Study Arms (2)

Exenatide once weekly (EQW)

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

Insulin Glargine (IG)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Commercial Insurance

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Truven health: collaborator

Study Sites (1)

Research site

Wilmington, Delaware, United States

Location

Related Links

• Synopsis\_D5551R00012

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Eric T. Wittbrodt, PharmD, MPH

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 25, 2016
• Study Start: August 15, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

US (1)