Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes (MK-0000-113)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: November 11, 2011
Last updated: January 9, 2014
Last verified: January 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes
Primary Outcome Measures:
- Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) At 4 Years [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
HOMA % B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L)-
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Participants receiving routine care under a diabetologist.
|Ages Eligible for Study:
||41 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Participants visiting a diabetologist as part of their routine care. Investigator's prescription is not influenced by the study: Investigator decides about what is the best treatment for any single participant independently of the study.
- 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
- Participation in a clinical trial in the previous 1 year
- Currently using insulin
- Type 1 diabetes
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No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 11, 2011
||January 9, 2014
||Italy: The Italian Medicines Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders