Universität zu Köln

Freemantle, Nick, Chou, Engels, Frois, Christian ORCID: 0000-0002-4397-2657, Zhuo, Daisy, Lehmacher, Walter, Vlajnic, Aleksandra, Wang, Hongwei, Chung, Hsing-wen, Zhang, Quanwu, Wu, Eric and Gerrits, Charles (2016). Safety and efficacy of insulin glargine 300 u/mL compared with other basal insulin therapies in patients with type 2 diabetes mellitus: a network meta-analysis. BMJ Open, 6 (2). LONDON: BMJ PUBLISHING GROUP. ISSN 2044-6055

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Abstract

Objective: To compare the efficacy and safety of a concentrated formulation of insulin glargine (Gla-300) with other basal insulin therapies in patients with type 2 diabetes mellitus (T2DM). Design: This was a network meta-analysis (NMA) of randomised clinical trials of basal insulin therapy in T2DM identified via a systematic literature review of Cochrane library databases, MEDLINE and MEDLINE In-Process, EMBASE and PsycINFO. Outcome measures: Changes in HbA1c (%) and body weight, and rates of nocturnal and documented symptomatic hypoglycaemia were assessed. Results: 41 studies were included; 25 studies comprised the main analysis population: patients on basal insulin-supported oral therapy (BOT). Change in glycated haemoglobin (HbA1c) was comparable between Gla-300 and detemir (difference: -0.08; 95% credible interval (CrI): -0.40 to 0.24), neutral protamine Hagedorn (NPH; 0.01; -0.28 to 0.32), degludec (-0.12; -0.42 to 0.20) and premixed insulin (0.26; -0.04 to 0.58). Change in body weight was comparable between Gla-300 and detemir (0.69; -0.31 to 1.71), NPH (-0.76; -1.75 to 0.21) and degludec (-0.63; -1.63 to 0.35), but significantly lower compared with premixed insulin (-1.83; -2.85 to -0.75). Gla-300 was associated with a significantly lower nocturnal hypoglycaemia rate versus NPH (risk ratio: 0.18; 95% CrI: 0.05 to 0.55) and premixed insulin (0.36; 0.14 to 0.94); no significant differences were noted in Gla-300 versus detemir (0.52; 0.19 to 1.36) and degludec (0.66; 0.28 to 1.50). Differences in documented symptomatic hypoglycaemia rates of Gla-00 versus detemir (0.63; 0.19to 2.00), NPH (0.66; 0.27 to 1.49) and degludec (0.55; 0.23 to 1.34) were not significant. Extensive sensitivity analyses supported the robustness of these findings. Conclusions: NMA comparisons are useful in the absence of direct randomised controlled data. This NMA suggests that Gla-300 is also associated with a significantly lower risk of nocturnal hypoglycaemia compared with NPH and premixed insulin, with glycaemic control comparable to available basal insulin comparators.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Freemantle, Nick UNSPECIFIED UNSPECIFIED UNSPECIFIED Chou, Engels UNSPECIFIED UNSPECIFIED UNSPECIFIED Frois, Christian UNSPECIFIED orcid.org/0000-0002-4397-2657 UNSPECIFIED Zhuo, Daisy UNSPECIFIED UNSPECIFIED UNSPECIFIED Lehmacher, Walter UNSPECIFIED UNSPECIFIED UNSPECIFIED Vlajnic, Aleksandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Wang, Hongwei UNSPECIFIED UNSPECIFIED UNSPECIFIED Chung, Hsing-wen UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang, Quanwu UNSPECIFIED UNSPECIFIED UNSPECIFIED Wu, Eric UNSPECIFIED UNSPECIFIED UNSPECIFIED Gerrits, Charles UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-289292
DOI:	10.1136/bmjopen-2015-009421
Journal or Publication Title:	BMJ Open
Volume:	6
Number:	2
Date:	2016
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	2044-6055
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TREAT-TO-TARGET; RANDOMIZED CONTROLLED-TRIAL; GLUCOSE-LOWERING DRUGS; NOCTURNAL HYPOGLYCEMIC EVENTS; NPH INSULIN; OPEN-LABEL; PREMIXED INSULIN; GLYCEMIC CONTROL; PARALLEL-GROUP; NAIVE PATIENTS Multiple languages Medicine, General & Internal Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28929