A Multinational Observational Study Assessing Insulin Use: Understanding the Challenges Associated With Progression of Therapy - The MOSAIc Type 2 Diabetes Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Eli Lilly and Company
- Enrollment
- 4299
- Locations
- 1
- Primary Endpoint
- Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have been diagnosed with type 2 diabetes
- •Have presented within the normal course of care
- •Have been on their initial insulin therapy for ≥3 months (with or without any combination of approved non-insulin anti-diabetic medications)
- •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 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
- •Have not initiated basal bolus therapy (three mealtime insulin injections)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy
Time Frame: Baseline through 24 months
Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Discrimination domain of the Interpersonal Processes of Care Survey \[IPC\] ranges from 1-5 with higher scores indicating more discrimination and Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.
Secondary Outcomes
- Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study(Baseline through 24 months)
- Number of Hypoglycemic and Severe Hypoglycemic Episodes(Baseline through 24 months)
- Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent)(Baseline through 24 months)