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01.12.2012 | Study protocol | Ausgabe 1/2012 Open Access

Cardiovascular Diabetology 1/2012

Achievement of recommended glucose and blood pressure targets in patients with type 2 diabetes and hypertension in clinical practice – study rationale and protocol of DIALOGUE

Zeitschrift:
Cardiovascular Diabetology > Ausgabe 1/2012
Autoren:
Anselm K Gitt, Roland E Schmieder, Eva Duetting, Peter Bramlage, Steffen Schneider, Diethelm Tschöpe, DIALOGUE Study Group*
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2840-11-148) contains supplementary material, which is available to authorized users.

Competing interests

Anselm K Gitt (AKG), Roland E. Schmieder (RES), Peter Bramlage (PB), and Diethelm Tschöpe (DT) have received research support and honoraria for lectures from a number of pharmaceutical companies producing anti-diabetic drugs including Novartis the sponsor of this study. Eve Duetting (ED) is employee of the sponsor. Steffen Schneider (StS) has no potential conflict of interest to disclose.

Authors’ contributions

AKG, ED, RES and DT designed the registry. StS is responsible for the analysis of data. PB drafted the manuscript based on the protocol and all other authors revised the article for important intellectual content. All authors have finally approved the version to be published.

Abstract

Background

Patients with type 2 diabetes have 2–4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD.

Methods

DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1) individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2) individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE) and the rate of hospitalizations are the most important.

Conclusion

The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti-diabetic and anti-hypertensive drugs in clinical trials and their real world balance of effectiveness and safety.
Zusatzmaterial
Authors’ original file for figure 1
12933_2012_581_MOESM1_ESM.pdf
Authors’ original file for figure 2
12933_2012_581_MOESM2_ESM.pdf
Literatur
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