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
Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)
1 other identifier
observational
1,523
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedResults Posted
Study results publicly available
January 23, 2012
CompletedAugust 27, 2015
August 1, 2015
1.4 years
August 2, 2011
December 15, 2011
August 26, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline for Mean Hemoglobin A1c (HbA1C)
Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.
Baseline and end of Observation (up to Month 6)
Change From Baseline for Mean Fasting Blood Glucose (FBG)
Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.
Baseline and end of Observation (up to Month 6)
Study Arms (1)
All Enrolled Participants
Eligibility Criteria
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.
You may qualify if:
- \- 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
You may not qualify if:
- \- Currently being administered a combination therapy for the treatment of their Type 2 diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2011
First Posted
August 4, 2011
Study Start
August 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
August 27, 2015
Results First Posted
January 23, 2012
Record last verified: 2015-08