Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone
Overview[ - collapse ][ - ]
| 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 | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Rosiglitazone + Metformin Drug: Sitagliptin + Metformin |
| Phase | N/A |
| Sponsor | GlaxoSmithKline |
| Responsible Party | GlaxoSmithKline |
| ClinicalTrials.gov Identifier | NCT01332370 |
| First Received | April 7, 2011 |
| Last Updated | June 23, 2011 |
| Last verified | June 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 7, 2011 |
|---|---|
| Last Updated Date | June 23, 2011 |
| Start Date | December 2009 |
| Estimated Primary Completion Date | December 2010 |
| Current 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 |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone |
|---|---|
| Official Title | Prescription Patterns, Resource Utilization & Costs - Add-on Therapy With Anti Dipeptidyl Peptidase-IVs vs Rosiglitazone |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Observational |
| Study Phase | N/A |
| Study Design | Observational Model: Cohort, Time Perspective: Retrospective |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | 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) |
| Study Arm (s) | Adults with Type 2 Diabetes Subjects with a diagnosis (ICD-9 code) of diabetes |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 5391 |
| Estimated Completion Date | December 2010 |
| Estimated Primary Completion Date | December 2010 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01332370 |
|---|---|
| Other Study ID Numbers | 112611 |
| Has Data Monitoring Committee | No |
| Information Provided By | GlaxoSmithKline |
| Study Sponsor | GlaxoSmithKline |
| Collaborators | Not Provided |
| Investigators | Study Director: GSK Clinical Trials GlaxoSmithKline |
| Verification Date | June 2011 |