A Study of the Current Medical Practice and Outcomes in the Treatment of Type 2 Diabetes Mellitus in an Office Setting (MK-0431-199) (SIRTA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01409213
First received: August 2, 2011
Last updated: December 15, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to collect information of the risk profile of patients with type 2 diabetes mellitus, their treatment concerning meeting the guidelines for treatment of diabetic patients type 2 published by the Deutsche Diabetes Gesellschaft (DDG) on October 13, 2008


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change From Baseline for Mean Hemoglobin A1c (HbA1C) [ Time Frame: Baseline and end of Observation (up to Month 6) ] [ Designated as safety issue: No ]
    Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.

  • Change From Baseline for Mean Fasting Blood Glucose (FBG) [ Time Frame: Baseline and end of Observation (up to Month 6) ] [ Designated as safety issue: No ]
    Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.


Enrollment: 1523
Study Start Date: August 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Enrolled Participants

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants with type 2 diabetes mellitus being treated in an office setting with metformin at the individual maximal tolerated dose (at least four weeks on stable dose) and had a resultant HbA1c >6.5% were selected for this study. The first five eligible participants per site with type 2 diabetes mellitus and treatment with metformin were to be enrolled.

Criteria

Inclusion Criteria:

  • Newly diagnosed with Type 2 diabetes in whom treatment with metformin in the individual maximal tolerated dose (at least four weeks on stable dose) resulted in HbA1c >6.5%
  • No contraindication or intolerability to metformin

Exclusion Criteria:

- Currently being administered a combination therapy for the treatment of their Type 2 diabetes

  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: NCT01409213     History of Changes
Other Study ID Numbers: MK-0431-199
Study First Received: August 2, 2011
Results First Received: December 15, 2011
Last Updated: December 15, 2011
Health Authority: Germany: The Bavarian State Ministry of the Environment and Public Health

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

ClinicalTrials.gov processed this record on July 22, 2014