Exp Clin Endocrinol Diabetes 2020; 128(03): 170-181
DOI: 10.1055/a-0636-3961
Article
© Georg Thieme Verlag KG Stuttgart · New York

Quality of Life, Glycemic Control, Safety and Tolerability Associated with Liraglutide or Insulin Initiation in Patients with Type 2 Diabetes in Germany: Results from the Prospective, Non-interventional LIBERTY Study

Rainer Lundershausen
1  Diabetes Centre Erfurt/Bad Berka, Erfurt, Germany
,
Sabrina Müller
2  Institut für Pharmakoökonomie und Arzneimittellogistik (IPAM), Wismar, Germany
,
Mahmoud Hashim
3  Ingress Health, AC Rotterdam, The Netherlands
,
Joachim Kienhöfer
4  Novo Nordisk Pharma GmbH, Mainz, Germany
,
Stefan Kipper
4  Novo Nordisk Pharma GmbH, Mainz, Germany
,
Thomas Wilke
2  Institut für Pharmakoökonomie und Arzneimittellogistik (IPAM), Wismar, Germany
› Author Affiliations
Funding This study was supported by Novo Nordisk Pharma GmbH, which initiated the study and was involved in the study design, collected case report forms completed by treating physicians, and was responsible for data management. The statistical analyses were performed under the supervision of Novo Nordisk Pharma GmbH. Novo Nordisk reviewed this article for medical accuracy. Two of the authors are employees of Novo Nordisk Pharma GmbH and were involved in interpretation of the data, preparation of the article, and decision to submit the article for publication.
Further Information

Publication History

received 12 December 2017
revised 09 May 2018

accepted 29 May 2018

Publication Date:
29 August 2018 (online)

Abstract

Purpose To assess quality of life, glycemic control, and safety/tolerability associated with liraglutide versus insulin initiation in patients with type 2 diabetes in Germany.

Methods Liraglutide/insulin-naïve adults with type 2 diabetes and inadequate glycemic control despite using oral antidiabetic medication were assigned to liraglutide (≤1.8 mg daily; n=878) or any insulin (n=382) according to the treating physician’s decision and followed for 52 weeks. The primary objective was to evaluate Audit of Diabetes-Dependent Quality of Life (ADDQoL) scores.

Results At baseline, the liraglutide group was younger and had shorter type 2 diabetes duration, lower glycated hemoglobin (HbA1c), higher body mass index, and a lower prevalence of certain diabetes-related complications than the insulin group (all p<0.05). ADDQoL average weighted impact scores improved numerically in both groups from baseline to 52 weeks (mean difference [95% confidence interval], liraglutide vs. insulin: 0.159 [−0.023;0.340]; not significant). Changes in general wellbeing and five ADDQoL domains significantly favored liraglutide (remaining 14 domains, not significant). HbA1c reductions were greater with insulin than liraglutide (−2.0% vs. −1.2%; p<0.01); however, mean HbA1c after 52 weeks was 7.2% in both groups. Compared with insulin, liraglutide significantly decreased body mass index (−1.54 kg/m2 vs. +0.27 kg/m2; p<0.001), systolic blood pressure (−5.03 mmHg vs. −1.03 mmHg; p<0.01) and non-severe hypoglycemia (0.85% vs. 4.55% at 52 weeks; p<0.01). Adverse drug reactions were reported for<3% of patients in both groups.

Conclusions Liraglutide improved certain ADDQoL components and reduced body mass index, systolic blood pressure, and non-severe hypoglycemia versus insulin. Both treatments improved glycemic control.

Supporting Information