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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
ClinicalTrials.gov Identifier:
NCT01409213
First received: August 2, 2011
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
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 May 23, 2013