N/A
Completed N=507
Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes (MK-0000-113)
Source: ClinicalTrials.gov NCT01472341 ↗Enrolled (actual)
507
Serious AEs
0.2%
Results posted
Feb 2015
Primary outcomePrimary: Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years — 50.2; 48.3 Percentage of Beta Cell Function — p=0.24
Summary
The purpose of this study is to evaluate the degree of beta-cell dysfunction among participants with type 2 diabetes and the association between beta-cell dysfunction and demographic, clinical, and treatment variables.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years |
50.2; 48.3 | 0.24 |
| PRIMARY Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years |
1.19; 1.61 | 0.001 sig |
| PRIMARY Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio |
73.4; 51.6; 37.7; 29.9 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Physician diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria
- Oral hypoglycemic drug therapy for ≥1 year
- Continuous care at the clinic (at least 2 visits) for at least one year
- Medical records completed with a minimum core data set
- Completed consent form
Exclusion Criteria
- Participation in a clinical trial in the previous 1 year
- Currently using insulin
- Type 1 diabetes
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01472341). 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.