Dapagliflozin Patient Satisfaction Survey

• ClinicalTrials.gov Identifier: NCT02805283
• Recruitment Status: Completed
• First Posted: June 20, 2016
• Last Update Posted: October 30, 2019
• Sponsor: AstraZeneca
• 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

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

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

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