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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Rosiglitazone + Metformin; Drug: Sitagliptin + Metformin

• Study Type: Observational
• Enrollment (Actual): 5391

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with Type 2 Diabetes; Subjects with a diagnosis (ICD-9 code) of diabetes	Drug: Rosiglitazone + Metformin; At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG; Other Names: Avandia(TM); Drug: Sitagliptin + Metformin; At least 180 days of continuous therapy with STG+MET after the first Rx for STG; Other Names: Januvia(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 7, 2011
• First Posted (Estimate): April 11, 2011

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Rosiglitazone; Type 2 Diabetes; Sitagliptin; Retrospective; Cost Analysis
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Rosiglitazone; Sitagliptin Phosphate
• Other Study ID Numbers: 112611