Last updated: 11/03/2018 13:08:49
Prescription Patterns, Resource Utilization & Costs - Add-on Therapy with Anti Dipeptidyl Peptidase-IVs vs rosiglitazone
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Prescription Patterns, Resource Utilization & Costs - Add-on Therapy with Anti Dipeptidyl Peptidase-IVs vs rosiglitazone
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
medical resource utilization
Timeframe: at least 12 months following first prescription with RSG or STG as an add-on therapy to MET monotherapy.
Secondary outcomes:
Not applicable
Interventions:
Drug: Rosiglitazone + Metformin
Drug: Sitagliptin + Metformin
Enrollment:
5391
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
December 2009 to December 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
No
- 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)
- 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
Inclusion and exclusion 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
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2010-23-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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