Last updated: 11/07/2018 03:15:17
ADA T2D Guidelines - Adherence & Economic Outomces: AVN+Met vs SUL+Met among Persistent Patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Impact of ADA Treatment Guidelines for Type 2 Diabetes on Adherence and Economic Outcomes: Avandia plus Metformin therapy vs. Sulfonylurea plus Metformin therapy among Persistent Patients
Trial description: GHO-08-0328: Impact of ADA Treatment Guidelines for Type 2 Diabetes on Adherence and Economic Outcomes: Avandia plus Metformin therapy vs. Sulfonylurea plus Metformin therapy among Persistent Patients
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To compare healthcare resource utilization (inpatient stays and outpatient visits) and costs (inpatient, outpatient, pharmacy, and total) for patients receiving RSG or SU as add-on to MET monotherapy.
Timeframe: Outcomes assessed over a 12-month period post addition or RSG or SU.
Secondary outcomes:
Not applicable
Interventions:
Drug: Rosiglitazone, Metformin
Drug: Sulfonylurea, Metformin
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Ma L, Wu N, Russo PA, Harrow B, Menditto L, Arondekar B. Comparative study of Rosiglitazone versus Sulfonylurea as the add-on therapy: Economic Analysis of Type 2 Diabetes. [Am J Pharm Benef]. 2012;4(1):e1-e7.
Medical condition
Diabetes Mellitus, Type 2
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
February 2009 to September 2009
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 85 Year
Accepts healthy volunteers
none
- Had at least one pharmacy claim for rosiglitazone or SU between July 1, 2000 and December 31, 2005 and the initial claim within the time window is the indexed event; had a first prescription for rosiglitazone or SU between July 1, 2000 and December 31, 2004.
- Was 18+ years of age as of the index date;
Inclusion and exclusion criteria
Inclusion criteria:
- Had at least one pharmacy claim for rosiglitazone or SU between July 1, 2000 and December 31, 2005 and the initial claim within the time window is the indexed event; had a first prescription for rosiglitazone or SU between July 1, 2000 and December 31, 2004. Was 18+ years of age as of the index date; Had no pharmacy claim for Avandia in 12 months prior to the index date; Had only metformin monotherapy treatment for at least 90 days in 12 months prior to the index date; Had continuous health plan enrollment for 12 months prior to and following the index date; Had at least one prescription of metformin in the follow-up period; and Had at least one year MPR (Medical Possession Rate) for Avandia equal to or higher than 0.80
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
2009-30-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website