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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01472341
First received: November 11, 2011
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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


Estimated Enrollment: 500
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Estimated 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01472341     History of Changes
Other Study ID Numbers: MK-0000-113
Study First Received: November 11, 2011
Last Updated: November 22, 2011
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on May 23, 2013