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

NCT01332370 | Completed

• 1 other identifier: 112611
• Study Type: observational
• Target: 5,391
• Locations: 0 countries
• Sites: N/A

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

Keywords

Retrospective; Type 2 Diabetes; Cost Analysis; Rosiglitazone; Sitagliptin

Outcome Measures

Primary Outcomes (1)

• medical resource utilization

  Direct healthcare and indirect sick leave costs

  at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.

Study Arms (1)

Adults with Type 2 Diabetes

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

Drug: Rosiglitazone + Metformin; Drug: Sitagliptin + Metformin

Interventions

Rosiglitazone + Metformin DRUG

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

Also known as: Avandia(TM)

Adults with Type 2 Diabetes

Sitagliptin + Metformin DRUG

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

Also known as: Januvia(R)

Adults with Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults continuously enrolled in a large US health insurance plan with a diagnosis of diabetes who are currently receiving Metformin

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

rosiglitazone-metformin combination; Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 2, 2017

Record last verified: 2011-06