Dapagliflozin Patient Satisfaction Survey

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805283
• Other study ID #: D1690R00026
• Status: Completed
• Start date: June 22, 2016
• Est. completion date: October 29, 2018

Study information

• Verified date: October 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
United States	Reasearch Site	Eden Prairie	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Optum, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condition-specific treatment satisfaction	Condition-specific treatment satisfaction as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)	2 weeks
Secondary	Medical Outcomes Study (MOS) Short Form Health Survey SF-12 or SF-36	MOS Short Form Health Survey SF-12 or SF-36	4 weeks
Secondary	Morisky Medication Adherence Scale	Medication adherence	1 month
Secondary	Hypoglycemia Fear Survey	Fear of hypoglycemia (HFS)	4 weeks
Secondary	Self-reported body weight	Self-reported body weight	1 month

External Links

•   CSR synopsis