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Completed

NCT Number: NCT01409213

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Acronym: SIRTA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 4, 2011
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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