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

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: February 4, 2015
Last verified: February 2015
  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:
  • Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years [ Time Frame: Baseline and 4 years ] [ Designated as safety issue: No ]
    HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5.

  • Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years [ Time Frame: Baseline and Year 4 ] [ Designated as safety issue: No ]
    Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.

  • Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.


Enrollment: 507
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472341

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  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
Results First Received: February 4, 2015
Last Updated: February 4, 2015
Health Authority: Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on September 02, 2015