Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone

NCT ID: NCT01332370

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5391 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-12-31

Brief Summary

This retrospective database study analyzed resource utilization and costs associated with sitagliptin (STG) in comparison with rosiglitazone (RSG) added to metformin (MET) monotherapy among adults with a diagnosis of diabetes who were continuously enrolled in a large US healthcare plan.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Adults with Type 2 Diabetes

Subjects with a diagnosis (ICD-9 code) of diabetes

Rosiglitazone + Metformin

Intervention Type: DRUG

At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG

Sitagliptin + Metformin

Intervention Type: DRUG

At least 180 days of continuous therapy with STG+MET after the first Rx for STG

Interventions

Rosiglitazone + Metformin

At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG

Intervention Type: DRUG

Sitagliptin + Metformin

At least 180 days of continuous therapy with STG+MET after the first Rx for STG

Intervention Type: DRUG

Other Intervention Names

Avandia(TM); Januvia(R)

Eligibility Criteria

Inclusion Criteria

• Continuously enrolled in the health insurance plan to ensure complete claims coverage
• At least 1 claim with a diagnosis of diabetes (ICD-9 250.xx)
• Aged 18 years or older at the index date
• At least 6 months of baseline period prior to the index date
• At least 1 claim for MET during the baseline period
• At least 180 days of continuous therapy with RSG+MET or STG+MET after the index date

Exclusion Criteria

• At least 1 claim for insulin or sulfonylurea in the baseline period
• At least 1 claim with a diagnosis of congestive heart failure in the baseline period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

112611

Identifier Type: -

Identifier Source: org_study_id