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

NCT ID: NCT01472341

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 507 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

Participants receiving routine care under a diabetologist.

No interventions assigned to this group

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

• Minimum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

0000-113

Identifier Type: -

Identifier Source: org_study_id