PMID- 26880669 OWN - NLM STAT- MEDLINE DCOM- 20161031 LR - 20240327 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 6 IP - 2 DP - 2016 Feb 15 TI - 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. PG - e009421 LID - 10.1136/bmjopen-2015-009421 [doi] LID - e009421 AB - 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-300 versus detemir (0.63; 0.19 to 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. CI - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ FAU - Freemantle, Nick AU - Freemantle N AD - Department of Primary Care and Population Health, University College London, London, UK. FAU - Chou, Engels AU - Chou E AD - Global Evidence & Value Development/Health Economics & Outcomes Research, Sanofi, Bridgewater, New Jersey, USA. FAU - Frois, Christian AU - Frois C AD - Analysis Group, AG, Boston, Massachusetts, USA. FAU - Zhuo, Daisy AU - Zhuo D AD - Analysis Group, AG, Boston, Massachusetts, USA. FAU - Lehmacher, Walter AU - Lehmacher W AD - Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany. FAU - Vlajnic, Aleksandra AU - Vlajnic A AD - Global Medical Affairs Diabetes, Sanofi, Bridgewater, New Jersey, USA. FAU - Wang, Hongwei AU - Wang H AD - Global Evidence & Value Development/Health Economics & Outcomes Research, Sanofi, Bridgewater, New Jersey, USA. FAU - Chung, Hsing-Wen AU - Chung HW AD - TechData Service Company, LLC, King of Prussia, Pennsylvania, USA. FAU - Zhang, Quanwu AU - Zhang Q AD - Global Evidence & Value Development/Health Economics & Outcomes Research, Sanofi, Bridgewater, New Jersey, USA. FAU - Wu, Eric AU - Wu E AD - Analysis Group, AG, Boston, Massachusetts, USA. FAU - Gerrits, Charles AU - Gerrits C AD - Global Evidence & Value Development/Health Economics & Outcomes Research, Sanofi, Bridgewater, New Jersey, USA. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Review PT - Systematic Review DEP - 20160215 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 2ZM8CX04RZ (Insulin Glargine) SB - IM MH - Body Weight/drug effects MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Glycated Hemoglobin/metabolism MH - Humans MH - Hypoglycemia/chemically induced MH - Hypoglycemic Agents/*adverse effects/*therapeutic use MH - Insulin Glargine/*adverse effects/*therapeutic use PMC - PMC4762107 OTO - NOTNLM OT - DIABETES & ENDOCRINOLOGY EDAT- 2016/02/18 06:00 MHDA- 2016/11/01 06:00 PMCR- 2016/02/15 CRDT- 2016/02/17 06:00 PHST- 2016/02/17 06:00 [entrez] PHST- 2016/02/18 06:00 [pubmed] PHST- 2016/11/01 06:00 [medline] PHST- 2016/02/15 00:00 [pmc-release] AID - bmjopen-2015-009421 [pii] AID - 10.1136/bmjopen-2015-009421 [doi] PST - epublish SO - BMJ Open. 2016 Feb 15;6(2):e009421. doi: 10.1136/bmjopen-2015-009421.