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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01472341
First received: November 11, 2011
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Beta-Cell Dysfunction and Insulin Resistance Among Italian Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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)-

    3.5



Enrollment: 508
Study Start Date: November 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Participants
Participants receiving routine care under a diabetologist.

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01472341     History of Changes
Other Study ID Numbers: 0000-113
Study First Received: November 11, 2011
Last Updated: January 9, 2014
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on September 22, 2014