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Open Access Highly Accessed Study protocol

Diabetes treatment patterns and goal achievement in primary diabetes care (DiaRegis) - study protocol and patient characteristics at baseline

Peter Bramlage1, Christiane Binz2, Anselm K Gitt3, Michael Krekler2, Tanja Plate4, Evelin Deeg3 and Diethelm Tschöpe5*

Author Affiliations

1 Institute for Cardiovascular Pharmacology and Epidemiology, Mahlow, Germany

2 Bristol Myers Squibb, Medical Department, Munich, Germany

3 Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg, Ludwigshafen, Germany

4 AstraZeneca, Medical Department, Wedel, Germany

5 Herz- und Diabeteszentrum Nordrhein-Westfalen in Bad Oeynhausen, Universitätsklinik der Ruhr Universität, Bochum, Germany

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Cardiovascular Diabetology 2010, 9:53  doi:10.1186/1475-2840-9-53

Published: 16 September 2010

Abstract

Background

Patients with type 2 diabetes are at an increased risk for disease and treatment related complications after the initial approach of oral mono/dual antidiabetic therapy has failed. Data from clinical practice with respect to this patient group are however scarce. Therefore we set up a registry in primary care documenting the course and outcomes of this patient group.

Methods

Diabetes Treatment Patterns and Goal Achievement in Primary Diabetes Care (DiaRegis) is a prospective, observational, German, multicenter registry including patients with type-2 diabetes in which oral mono/dual antidiabetic therapy has failed. Data were recorded at baseline and will be prospectively documented during visits at 6 ± 1, 12 ± 2 and 24 ± 2 months. The primary objective is to estimate the proportion of patients with at least 1 episode of severe hypoglycemia within one year.

Results

313 primary care offices included 4,048 patients between June 2009 and March 2010 of which 3,810 patients fulfilled the in- and exclusion criteria. 46.7% of patients were female; patients had a median diabetes duration of 5.5 years and most were obese with respect to BMI or waist circumference. HbA1c at baseline was 7.4%, fasting plasma glucose 142 mg/dl and postprandial glucose 185 mg/dl. Co-morbidity in this patient population was substantial with 17.9% having coronary artery disease, 14.4% peripheral neuropathy, 9.9% heart failure and 6.0% peripheral arterial disease. 68.6% of patients received oral monotherapy, 31.4% dual oral combination therapy. The most frequent antidiabetic agent used as monotherapy was metformin (79.0%) followed by sulfonylureas (14.8%).

Conclusions

DiaRegis is a large, prospective registry in primary diabetes care to document the course and outcomes of patients with type-2 diabetes in which the initial approach of oral mono/dual antidiabetic therapy has failed. The two year follow-up will allow for a prospective evaluation of these patients during multiple adjustments of therapy.