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Dapagliflozin Patient Satisfaction Survey

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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

Study Description
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Brief Summary:
The purpose of this study is to evaluate the diabetes related treatment satisfaction for patients with type 2 diabetes mellitus

Condition or disease
Diabetes Mellitus, Type 2

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 Design
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Study Type : Observational
Actual Enrollment : 653 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Direct to Patient Survey to Examine Treatment Satisfaction and Experience With Dapagliflozin Compared to Sulfonylureas
Actual Study Start Date : June 22, 2016
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018

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Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Condition-specific treatment satisfaction [ Time Frame: 2 weeks ]
    Condition-specific treatment satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)


Secondary Outcome Measures :
  1. 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

  2. Morisky Medication Adherence Scale [ Time Frame: 1 month ]
    Medication adherence

  3. Hypoglycemia Fear Survey [ Time Frame: 4 weeks ]
    Fear of hypoglycemia (HFS)

  4. Self-reported body weight [ Time Frame: 1 month ]
    Self-reported body weight


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 Diabetes patients with administrative claims data from Optum Research Database (US Commercial Claims Data)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805283


Locations
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United States, Minnesota
Reasearch Site
Eden Prairie, Minnesota, United States
Sponsors and Collaborators
AstraZeneca
Optum, Inc.
Investigators
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Study Chair: Kelly Bell, PharmD, MSPhr AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02805283    
Other Study ID Numbers: D1690R00026
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Keywords provided by AstraZeneca:
Diabetes Mellitus, Type 2
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases