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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:
ClinicalTrials.gov Identifier:
NCT01332370
First Posted: April 11, 2011
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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. ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332370


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332370     History of Changes
Other Study ID Numbers: 112611
First Submitted: April 7, 2011
First Posted: April 11, 2011
Last Update Posted: June 2, 2017
Last Verified: June 2011

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
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action