gms | German Medical Science

10. Jahrestagung der GAA Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

16. bis 17.10.2003, Bonn

Results of a German observational study (Anwendungsbeobachtung) internationally considered as evidence for the real-life benefit of Insulin Glargin

Ergebnisse einer deutschen Anwendungsbeobachtung zum klinischen Nutzen von Insulin Glargin

Meeting Abstract

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  • corresponding author Matthias-Axel Schweitzer - Aventis Pharma Deutschland GmbH, Königsteiner Strasse 10, 65812 Bad Soden, Germany, Tel.: +49 (069) 305-18297

Gesellschaft für Arzneimittelanwendungsforschung u. Arzneimittelepidemiologie (GAA) e.V.. 10. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie (GAA) e.V.. Bonn, 16.-17.10.2003. Düsseldorf, Köln: German Medical Science; 2003. Doc03gaa03

The electronic version of this article is the complete one and can be found online at:

Published: October 16, 2003

© 2003 Schweitzer.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Background and Aim

The efficacy and safety of Insulin Glargin (I.G.), a long-acting insulin analogue with new chemical and pharmacological characteristics, are well known from controlled clinical studies. The aim of this observational, non-interventional, study was to confirm the benefits of IG in conditions of daily practice in Type 1 or 2 Diabetes Mellitus (DM) patients.

Material and Method

The study was conducted in Germany in approximately 10'000 patients (35% Type 1 DM, 65 % Type 2 DM) according to recommendations of the German Drug Law and the BfArM. Patients previously failing good metabolic control were treated for up to 8 weeks with IG. Duration of diabetes, diabetic complications, previous therapies, HbA1c at baseline and after 8 weeks were collected, as well as patients' opinion of the treatment, especially regarding hypoglycemia.


Mean HbA1c was 8.2 % in Type 1 and 8.8 % in Type 2 DM. In both groups, a relevant decrease of HbA1c was observed after 8 weeks (0.6 % and 1.2 % mean reduction in Type 1 and Type 2 DM respectively). On average, there was no significant variation of body weight. In both groups, numerous patients (70.3 % Type 1, 57.4% Type 2) reported to have experienced fewer hypoglycemic episodes than with previous regimens.

The results of this study were submitted to the NICE (National Institute for Clinical Excellence) in the UK and the Commission de Transparence in France, and considered by these institutions as valid supportive evidence in the evaluation of IG leading to reimbursement and pricing recommendations.


The value of well conducted observational non-interventional surveys as a useful tool to confirm under real life conditions the benefits of pharmaceuticals demonstrated in controlled clinical studies will be more and more recognized.