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

Type 2 Diabetes Mellitus Clinical Trial

— SIRTA  

Official title:

Standardized Non-interventional Register Investigating the Daily Clinical Practice for the Treatment of Patients With Diabetes Mellitus Type 2 (SIRTA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409213
• Other study ID #: 0431-199
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: August 26, 2015
• Start date: August 2009
• Est. completion date: January 2011

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1523
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No