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Diabetologie und Stoffwechsel 2016; 11(02): 163-171
DOI: 10.1055/s-0042-103931
Übersicht
© Georg Thieme Verlag KG Stuttgart · New York

Verwendung der Fixkombination aus Insulin degludec und Liraglutid bei Erwachsenen mit Typ-2-Diabetes als Option bei unzureichender Blutzuckereinstellung unter einer basalunterstützten oralen Therapie

Use of Fixed Combination of Insulin Degludec and Liraglutide in Adults with Type 2 Diabetes as an Option in Case of Inadequate Blood Glucose Control under Basal-Supported Oral Therapy
B. Wilhelm
1   Clinical, Medical & Regulatory Department, Novo Nordisk Pharma GmbH, Mainz, Germany
,
M. Blüher
2   Klinik und Poliklinik für Endokrinologie und Nephrologie, Universitätsklinikum Leipzig, Germany
› Author Affiliations
Further Information

Publication History

03 February 2016

17 February 2016

Publication Date:
25 April 2016 (online)

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Zusammenfassung

Einleitung: Für Menschen mit Typ-2-Diabetes stehen zur Intensivierung einer basalunterstützten oralen Therapie (BOT) bei nicht ausreichender Blutzuckereinstellung verschiedene Optionen zur Verfügung. Dazu gehören insbesondere die Dosissteigerung des Basalinsulins, die Zugabe eines kurz wirksamen Insulins und die Zugabe eines Glucagon-like-peptide-1-Rezeptoragonisten (GLP-1-RA). Außerdem kann der Wechsel des Basalinsulins erwogen werden. Die Fixkombination aus dem Basalinsulin Insulin degludec und dem GLP-1-RA Liraglutid (IDegLira) ermöglicht die Intensivierung einer BOT ohne zusätzliche Injektionen.

Methodik: Ausgehend von Ergebnissen aus dem DUAL-Studienprogramm zu IDegLira werden klinisch relevante Aspekte für die Verwendung dieser Fixkombination analysiert und mit anderen Optionen zur Intensivierung einer BOT verglichen.

Ergebnisse: In der DUAL-II-Studie führte die Umstellung auf IDegLira zu einer mittleren Reduktion des HbA1c nach 26 Wochen um 1,9 % im Vergleich zu 0,9 % bei einer alleinigen Umstellung des Basalinsulins auf Insulin degludec (IDeg) (p < 0,0001). Zudem wurde mit IDegLira eine mittlere Reduktion des Körpergewichts um 2,7 kg erreicht (p = 0,0019 versus IDeg). Hinsichtlich Hypoglykämien ergab sich kein signifikanter Unterschied. Die Rate der Patienten mit Übelkeit war mit 6,5 % verhältnismäßig gering, wenn dies mit früheren Studienergebnissen zu Liraglutid verglichen wird. In der DUAL-V-Studie wurde IDegLira mit einer Optimierung der Insulin glargin 100E/ml (IGlar)-Therapie verglichen. Erneut zeigten sich signifikante Vorteile für IDegLira bei der HbA1c-Reduktion (geschätzte Behandlungsdifferenz 0,59 %; 95 % CI –0,74; –0,45; p < 0,001) und hinsichtlich Körpergewichtsreduktion (geschätzte Behandlungsdifferenz –3,20 kg; 95 % CI –3,77; –2,64; p < 0,001). Zudem wurden im Vergleich zu IGlar signifikante Verbesserungen bei den bestätigten Hypoglykämien und bei Lebensqualitätsparametern erreicht.

Schlussfolgerung: In der Gesamtschau der Daten ermöglichte IDegLira deutliche HbA1c-Reduktionen bei vergleichbaren Hypoglykämieraten und vorteilhaften Ergebnissen bzgl. des Körpergewichts ohne zusätzliche Injektionen oder komplexe therapeutische Vorgaben. Limitationen einer Therapie mit IDegLira sind eine schwere Niereninsuffizienz, eine eingeschränkte Leberfunktion, eine isolierte Notwendigkeit zur gezielten postprandialen Blutzuckersenkung oder wenn von der festen Dosisrelation 0,036 mg Liraglutid pro Einheit IDeg abgewichen werden soll.

Abstract

Introduction: Various options are available for people with type 2 diabetes for intensification of a basal-supported oral therapy (BOT) when blood glucose control is inadequate. These include in particular a dose increase of the basal insulin, addition of a short-acting insulin and addition of a glucagon-like peptide-1 receptor agonist (GLP-1-RA). Moreover, a change of the basal insulin can be taken into consideration. The fixed combination of the basal insulin degludec and the GLP-1 RA liraglutide (IDegLira) enables an intensification of BOT without additional injections.

Methods: Based on results concerning the DUAL trial programme of IDegLira clinically relevant aspects for the use of this fixed combination are analysed and compared with other options for the intensification of BOT.

Results: In the DUAL II trial, the switch to IDegLira led to a mean reduction of the HbA1c after 26 weeks by 1.9 % compared with 0.9 % for the switch of the basal insulin to insulin degludec (IDeg) alone (p < 0.0001). Moreover, a mean reduction of body weight by 2.7 kg was achieved with IDegLira (p = 0.0019 versus IDeg). No significant difference was found for episodes of hypoglycaemia. The rate of patients with nausea of 6.5% was rather low compared with previous trial results for liraglutide. In the DUAL V trial, IDegLira was compared with an optimisation of insulin glargine 100 U/ml (IGlar) treatment. Again, significant benefits for IDegLira were seen in terms of HbA1c reduction (estimated treatment difference 0.59 %; 95 % CI – 0.74; – 0.45; p < 0.001) and in terms of body weight loss (estimated treatment difference – 3.20 kg; 95 % CI – 3.77; – 2.64; p < 0.001). Moreover, significant improvements have been achieved in terms of confirmed hypoglycaemia and quality of life parameters compared with IGlar.

Conclusion: The overall view of data suggests that IDegLira was able to clearly reduce the HbA1c with comparable rates of hypoglycaemia and beneficial body weight results without additional injections or complex therapeutic regimens. Limitations of treatment with IDegLira include severe renal insufficiency, impaired liver function, isolated need to reduce postprandial blood glucose or the need to deviate from the fixed dose relation of 0.036 mg liraglutide per IDeg unit.

Schlüsselwörter

Diabetes - Liraglutid - Insulin degludec - Fixkombination

Key words

diabetes - liraglutide - insulin degludec - fixed combination treatment
 

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