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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)

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ClinicalTrials.gov Identifier: NCT01409213
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : January 23, 2012
Last Update Posted : August 27, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Type 2 Diabetes Mellitus

Study Design

Study Type : Observational
Actual Enrollment : 1523 participants
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)
Study Start Date : August 2009
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

All Enrolled Participants

Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline for Mean Hemoglobin A1c (HbA1C) [ Time Frame: Baseline and end of Observation (up to Month 6) ]
    Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.

  2. Change From Baseline for Mean Fasting Blood Glucose (FBG) [ Time Frame: Baseline and end of Observation (up to Month 6) ]
    Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01409213     History of Changes
Other Study ID Numbers: 0431-199
First Posted: August 4, 2011    Key Record Dates
Results First Posted: January 23, 2012
Last Update Posted: August 27, 2015
Last Verified: August 2015

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