N/A N=507

Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes (MK-0000-113)

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01472341 ↗

Enrolled (actual)

507

Serious AEs

0.2%

Results posted

Feb 2015

Primary outcome: Primary: 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

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 41+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Dec 2013

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

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.

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

View full record on ClinicalTrials.gov →

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.