Dapagliflozin Patient Satisfaction Survey

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT02805283
• Lead Sponsor: AstraZeneca

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 Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-06-22
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 653

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Condition-specific treatment satisfaction	2 weeks	Condition-specific treatment satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia Fear Survey	4 weeks	Fear of hypoglycemia (HFS)
Medical Outcomes Study (MOS) Short Form Health Survey SF-12 or SF-36	4 weeks	MOS Short Form Health Survey SF-12 or SF-36
Morisky Medication Adherence Scale	1 month	Medication adherence
Self-reported body weight	1 month	Self-reported body weight

Trial Locations

Locations (1)

Reasearch Site; 🇺🇸 Eden Prairie, Minnesota, United States