DIALOGUE ‐ Evaluation of treatment patterns for hypertensive
diabetics to meet blood‐pressure and glucose targets

DIALOGUE ‐ Evaluation of treatment patterns for hypertensive
diabetics to meet blood‐pressure and glucose targets

To gain detailed insight on the characteristics and management of
patients with diabetes and hypertension with focus on various
treatment patterns and events.

Galvus und andere Antidiabetika

Nein

Rein exploratorische Untersuchung

Praxis/niedergelassener Bereich

Ja

Primary Objectives
To determine individual treatment success of different antidiabetic (incretin‐based and non‐incretinbased)
and antihypertensive (RAAS‐inhibitor and non‐RAAS‐inhibitors) medications and their
combinations by defining the number of T2DM hypertensive patients who reach their blood glucose
target values and blood pressure targets as pre‐defined by treating physician based on current
guidelines given by the DDG (Matthaei et al., 2011) and the ESH (Mancia et al., 2009) and remain
controlled over the observational period of 24 months (interim analyses performed at 6 months and
12 months, optional 36‐ and 48‐months follow‐up).

Secondary Objectives
1. To assess the proportion of patients reaching their blood glucose target values without
any of the following adverse effects: peripheral edema or proven hypoglycemic event or
discontinuation due to gastrointestinal event or significant weight gain (5 %)
2. To describe patient characteristics in patients with diabetes mellitus and hypertension in
clinical practice in the overall registry population
3. To document antidiabetic and anti‐hypertensive therapy and its success in diverse
subject populations, which have to be pre‐specified by the scientific committee (e.g.
females versus males, age 75y, patients on insulin versus patients not on insulin, etc.)
4. To verify the applicability of and the adherence to the current guidelines for the
treatment of diabetes and hypertension in clinical practice
5. To document drug utilisation patterns of drugs used for the treatment of diabetes as
well as hypertension in clinical practice
6. To evaluate adverse cardiovascular events, and diabetes related micro‐ and
macrovascular events
7. To evaluate the glycaemic profile
8. To evaluate the blood pressure profile
9. To evaluate comorbid disease conditions
10. To evaluate the change of the BMI over the course of the study
11. To evaluate the proportion of patients with hypoglycaemic events
12. To evaluate cardiovascular risk by using validated cardiovascular risk scores such as the
EURO Score
13. To evaluate health status (EQ‐5D)
14. To determine costs associated with the treatment and disease related complications
15. To document treatment persistence over time, change in treatments / dosing during a
follow‐up of years (optional up to 4 years of follow‐up)
16. To document patient reported outcome (PRO)

To attain an approximation of representative coverage of 0,2 – 0,25 % of all T2DM patients in
Germany (based on data given by Classen et al., 2009 “Innere Medizin”, Urban&Fischer publishing
house), a sample size of 10,000 will be evaluated within this observational study. This sample size will
ensure strong and robust data even in various sub‐populations that are of interest in T2DM defined
in the secondary objectives (e.g. elderly, patients with renal impairment, women, insulin add‐on
during the course of study etc.).

750

750

750

750

10000

10000

10000

10000

30

alle anderen Antidiabetika

01.08.2012

2 Jahre

42 Monate

CLAF237ADE09

Müller, Alfons

Phase IV Manager NIS

Novartis Pharma GmbH

Roonstr. 25

90429 Nürnberg

Deutschland

alfons.mueller@novartis.com

Telefon: 0911/273-12897

Telefax: 0911/273-15897

Novartis Pharma GmbH

Roonstr. 25

90429 Nürnberg

Deutschland

02.02.2016

Studie bereits abgeschlossen

vfa.de

2015-12-15_DIALOGUE_NIS-Report_FinalVersion.pdf