NCT02805283

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
653

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

June 22, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2018

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

2.4 years

First QC Date

June 2, 2016

Last Update Submit

October 28, 2019

Conditions

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Condition-specific treatment satisfaction

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

    2 weeks

Secondary Outcomes (4)

  • Medical Outcomes Study (MOS) Short Form Health Survey SF-12 or SF-36

    4 weeks

  • Morisky Medication Adherence Scale

    1 month

  • Hypoglycemia Fear Survey

    4 weeks

  • Self-reported body weight

    1 month

Study Arms (2)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Patients with evidence of type 1 diabetes mellitus and unknown type
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reasearch Site

Eden Prairie, Minnesota, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kelly Bell, PharmD, MSPhr

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 20, 2016

Study Start

June 22, 2016

Primary Completion

October 29, 2018

Study Completion

October 29, 2018

Last Updated

October 30, 2019

Record last verified: 2019-10

Locations