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NCT03078049 · ClinicalTrials.gov registry record
Characteristics of Patients With Type 2 Diabetes Mellitus Receiving Treatment With Dapagliflozin Versus Sitagliptin: An Analysis of Commercial Claims and Linked Laboratory Data
A clinical trial, sponsored by AstraZeneca.
- Completed
- Registry status
- 11,971
- Enrollment target
NCT03078049: Completed study, sponsored by AstraZeneca.
NCT03078049 is a clinical trial that has completed, run by AstraZeneca. The registered enrollment target is 11,971 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03078049 has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- 11,971 participants
- Enrollment target
Study Summary
Rationale: In order to compare the real-world use of commonly prescribed second-line oral diabetes therapies, real-world data comparing patients receiving treatment with dapagliflozin vs sitagliptin are needed, and limited resource use and cost data exist for patients initiating dapagliflozin in the real-world setting. Objectives: Primary: The primary objective of this study is to compare real-world health care resource utilization and costs following treatment with dapagliflozin versus sitagliptin. Secondary: The secondary objectives of this study are to assess clinical outcomes and treatment patterns among patients receiving treatment with dapagliflozin versus sitagliptin. Study Design: Retrospective cohort study. Target Subject Population: Patients receiving treatment with either dapagliflozin or sitagliptin will be evaluated. Study Variable(s): Primary Variables: Health care resource utilization and costs Secondary Variables: Demographics measured at the index date, Quan-Charlson Comorbidity score, measured during the baseline period, Agency for Healthcare Research and Quality (AHRQ)-based comorbidity measures, receipt of other antidiabetic medication classes during the baseline and follow-up periods, number and percentage of patients with a diagnosis of obesity during the baseline or follow-up periods, treatment patterns during the follow-up period (i.e., index dose, duration of treatment, discontinuation, adherence, receipt of additional antidiabetic medication classes), HbA1c outcomes (among subgroup of patients with linked laboratory data, sample size permitting), renal impairment, hypoglycemia as defined by a claims-based algorithm. Statistical Methods: Initial analyses will be descriptive in nature and entail the tabular display of mean values, medians, ranges, and standard deviations of continuous variables of interest (e.g., patient age) and frequency distributions for categorical variables (e.g., sex, geographic location). Outcomes will be compared
Primary Outcome
Number of patients with at least one hospital stay, number of unique stays and average length of stay.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11,971 participants |
| Start Date | 2017-03-31 |
| Est. Completion | 2017-05-31 |
What the finished NCT03078049 record still lists
NCT03078049 is an observational study that tracks outcomes without assigning an intervention. Its 11,971 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT03078049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03078049 about?
NCT03078049 is a clinical study titled "Characteristics of Patients With Type 2 Diabetes Mellitus Receiving Treatment With Dapagliflozin Versus Sitagliptin: An Analysis of Commercial Claims and Linked Laboratory Data". Rationale: In order to compare the real-world use of commonly prescribed second-line oral diabetes therapies, real-world data comparing patients receiving treatment with dapagliflozin vs sitagliptin are needed, and limited resource use and cost data exist for patients initiating dapagliflozin in the...
What is the current status of trial NCT03078049?
This trial is currently completed. The enrollment target is 11,971 participants. The study started on 2017-03-31. Estimated completion is 2017-05-31.
Who is sponsoring clinical trial NCT03078049?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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