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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: August 2, 2011
Last updated: August 5, 2014
Last verified: August 2014
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
||Observational Model: Cohort
Time Perspective: Prospective
||Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
All Enrolled Participants
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- No contraindication or intolerability to metformin
- Currently being administered a combination therapy for the treatment of their Type 2 diabetes
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No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2011
|Results First Received:
||December 15, 2011
||August 5, 2014
||Germany: The Bavarian State Ministry of the Environment and Public Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders