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Completed

NCT Number: NCT02805283

Dapagliflozin Patient Satisfaction Survey

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Reasearch Site

Eden Prairie, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Condition-specific treatment satisfaction

    Time frame: 2 weeks

    Condition-specific treatment satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Optum, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 20, 2016
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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