An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin

Eli Lilly and Company2,459 enrolled

Overview

The purpose of this study is to estimate the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and short-acting human insulin therapy within the first year following the switch. The additional goals are: 1)to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient quality of life, 3) to assess the impact of switch from or to the rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate the total costs (direct and indirect) associated with switching, in either direction between rapid-acting analog and short-acting human insulin within the first year following the switch.

Study Type

OBSERVATIONAL

Enrollment

2,459

Conditions

Diabetes Mellitus, Type 2

Interventions

Analog or Human InsulinDRUG

prescribed in accordance with usual clinical practice

Medical Language ↔ Plain English

Inclusion Criteria: * are at least 18 years of age * according to the clinical judgement of the investigator have been diagnosed with type II diabetes * have presented within the normal course of care * at the baseline visit are being treated with any therapy including a rapid-acting analog insulin component or any therapy including a short-acting human insulin component and are switching from one form of therapy to the other * are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study * have been fully informed and have given their written consent for the use of their data * have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires Exclusion Criteria: * no specific exclusion criteria exist for this study

Locations (27)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Purkersdorf, Austria

Beroun, Czechia

Bad Homburg, Germany

Athens, Greece

Outcomes

Primary Outcomes

The estimation of the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and a short-acting human insulin therapy within the first year following the switch.

Time frame: 1 year

Secondary Outcomes

Change in Euro Quality of Life (EQ-5D)

Time frame: 1 year

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Time frame: 1 year

Change in Diabetes Health Profile (DHP-18)

Time frame: 1 year

The estimation of the total costs (direct and indirect) associated with switching, in either direction, between rapid-acting analog and short-acting human insulin within the first year following the switch

Time frame: 1 year

Békéscsaba, Hungary

Budapest, Hungary

Dombóvár, Hungary

Dunaújváros, Hungary

Eger, Hungary

Esztergom, Hungary

An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin

Overview

Conditions

Interventions

Eligibility

Locations (27)

Outcomes

Primary Outcomes

Secondary Outcomes