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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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013