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Dapagliflozin Patient Satisfaction Survey

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.
 
ClinicalTrials.gov Identifier: NCT02805283
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
Optum, Inc.
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date June 2, 2016
First Posted Date June 20, 2016
Last Update Posted Date October 30, 2019
Actual Study Start Date June 22, 2016
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2016)
Condition-specific treatment satisfaction [ Time Frame: 2 weeks ]
Condition-specific treatment satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 15, 2016)
  • Medical Outcomes Study (MOS) Short Form Health Survey SF-12 or SF-36 [ Time Frame: 4 weeks ]
    MOS Short Form Health Survey SF-12 or SF-36
  • Morisky Medication Adherence Scale [ Time Frame: 1 month ]
    Medication adherence
  • Hypoglycemia Fear Survey [ Time Frame: 4 weeks ]
    Fear of hypoglycemia (HFS)
  • Self-reported body weight [ Time Frame: 1 month ]
    Self-reported body weight
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dapagliflozin Patient Satisfaction Survey
Official Title Direct to Patient Survey to Examine Treatment Satisfaction and Experience With Dapagliflozin Compared to Sulfonylureas
Brief Summary The purpose of this study is to evaluate the diabetes related treatment satisfaction for patients with type 2 diabetes mellitus
Detailed Description This is a cross-sectional, observational patient survey study. Study subjects will be adult commercial members of the large US health plan affiliated with Optum with evidence of T2D initiating dapagliflozin or a sulfonylurea medication within the 3 months prior to survey mailing.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Type 2 Diabetes patients with administrative claims data from Optum Research Database (US Commercial Claims Data)
Condition Diabetes Mellitus, Type 2
Intervention Not Provided
Study Groups/Cohorts
  • Dapagliflozin, dapagliflozin/met ER
    Dapagliflozin cohort have at least one pharmacy claim for either dapagliflozin or dapagliflozin/metformin ER in the most recent month of pharmacy data and no pharmacy claims for a medication in the same drug class during the 6 months prior to sample identification.
  • Sulfonylurea
    Sulfonylurea cohort have at least one pharmacy claim for sulfonylurea in the most recent month of pharmacy data and no pharmacy claims for a medication in the same drug class during the 6 months prior to sample identification.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 14, 2018)
653
Original Estimated Enrollment
 (submitted: June 15, 2016)
932
Actual Study Completion Date October 29, 2018
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • At least one pharmacy claim for dapagliflozin or dapagliflozin/metformin ER in the most recent month of pharmacy data and no pharmacy claims for an SGLT2 medication during the 6 months prior to sample identification.
  • Evidence of T2D diagnosis.
  • Age ≥18 as of the drug index date.
  • 6 months of continuous enrollment in a commercial health plan with both pharmacy and medical benefits during the identification period through the patient interview sample identification date.
  • Self-reported T2D diagnosis during the patient interview.

Exclusion Criteria:

  • Patients with evidence of type 1 diabetes mellitus and unknown type
  • Patients who are pregnant
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02805283
Other Study ID Numbers D1690R00026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Optum, Inc.
Investigators
Study Chair: Kelly Bell, PharmD, MSPhr AstraZeneca
PRS Account AstraZeneca
Verification Date October 2019