N/A
Completed N=4,299
An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01400971 ↗Enrolled (actual)
4,299
Serious AEs
5.1%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy — 2171 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy |
2171 | — |
| SECONDARY Number of Hypoglycemic and Severe Hypoglycemic Episodes |
7950; 225 | — |
| SECONDARY Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent) |
2446 | — |
| SECONDARY Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study |
392 | — |
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
- None
Data sourced from ClinicalTrials.gov (NCT01400971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.