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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332370
First received: April 7, 2011
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Drug: Rosiglitazone + Metformin
Drug: Sitagliptin + Metformin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • medical resource utilization [ Time Frame: at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy. ] [ Designated as safety issue: No ]
    Direct healthcare and indirect sick leave costs


Enrollment: 5391
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Avandia(TM)
Drug: Sitagliptin + Metformin
At least 180 days of continuous therapy with STG+MET after the first Rx for STG
Other Name: Januvia(R)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332370

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01332370     History of Changes
Other Study ID Numbers: 112611
Study First Received: April 7, 2011
Last Updated: June 23, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Retrospective
Type 2 Diabetes
Cost Analysis
Rosiglitazone
Sitagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014