Dapagliflozin Patient Satisfaction Survey

October 28, 2019 updated by: AstraZeneca

Direct to Patient Survey to Examine Treatment Satisfaction and Experience With Dapagliflozin Compared to Sulfonylureas

The purpose of this study is to evaluate the diabetes related treatment satisfaction for patients with type 2 diabetes mellitus

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

653

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Eden Prairie, Minnesota, United States
        • Reasearch Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 Diabetes patients with administrative claims data from Optum Research Database (US Commercial Claims Data)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Condition-specific treatment satisfaction
Time Frame: 2 weeks
Condition-specific treatment satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
Morisky Medication Adherence Scale
Time Frame: 1 month
Medication adherence
1 month
Hypoglycemia Fear Survey
Time Frame: 4 weeks
Fear of hypoglycemia (HFS)
4 weeks
Self-reported body weight
Time Frame: 1 month
Self-reported body weight
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Optum, Inc.

Investigators

  • Study Chair: Kelly Bell, PharmD, MSPhr, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2016

Primary Completion (Actual)

October 29, 2018

Study Completion (Actual)

October 29, 2018

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 28, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1690R00026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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