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Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial

Published on Nov 1, 2019in Diabetes Care15.27
· DOI :10.2337/dc19-1357
Lawrence Blonde37
Estimated H-index: 37
(Ochsner Medical Center),
Julio Rosenstock113
Estimated H-index: 113
+ 7 AuthorsVanita R. Aroda14
Estimated H-index: 14
(MedStar Health)
Abstract
OBJECTIVE Fixed-ratio combinations of basal insulin plus glucagon-like peptide 1 receptor agonist (GLP-1 RA) allow concomitant administration of two proven complementary injectable therapies for type 2 diabetes. This study investigated switching to a titratable fixed-ratio combination of insulin glargine plus lixisenatide (iGlarLixi) in patients with type 2 diabetes receiving daily or weekly GLP-1 RA therapy. RESEARCH DESIGN AND METHODS LixiLan-G, a randomized, open-label, 26-week trial, comparing switching to iGlarLixi versus continuing prior GLP-1 RA in patients with type 2 diabetes and HbA1c 7–9% (53–75 mmol/mol) taking maximum tolerated doses of a GLP-1 RA daily (60% on liraglutide once daily or exenatide twice daily) or weekly (40% on dulaglutide, exenatide extended release, or albiglutide) with metformin with or without pioglitazone and with or without sodium–glucose cotransporter 2 inhibitors. Adherence to randomized treatment was closely monitored throughout the study. RESULTS iGlarLixi (n = 257) reduced HbA1c more than continued GLP-1 RA therapy (n = 257) from a baseline 7.8% (62 mmol/mol) in both to 6.7% (50 mmol/mol) and 7.4% (57 mmol/mol), respectively, at 26 weeks (least squares mean difference −0.6%; P CONCLUSIONS Switching to iGlarLixi improves glucose control for patients with type 2 diabetes insufficiently controlled on a maximum tolerated dose of a GLP-1 RA plus oral antihyperglycemic agents.
  • References (12)
  • Citations (1)
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References12
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#1Marco Castellana (University of Bari)H-Index: 3
#2Angelo Cignarelli (University of Bari)H-Index: 14
Last. Francesco Giorgino (University of Bari)H-Index: 44
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#1Melanie J. Davies (University of Leicester)H-Index: 82
#2David A. D'Alessio (Duke University)H-Index: 71
Last. John B. Buse (UNC: University of North Carolina at Chapel Hill)H-Index: 97
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The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the prior position statements, published in 2012 and 2015, on the management of type 2 diabetes in adults. A systematic evaluation of the literature since 2014 informed new recommendations. These include additional focus on lifestyle management and diabetes self-management education and support. For those with obesity, efforts targeting weight loss, including lifestyle, medication,...
299 CitationsSource
#1Maria Ida MaiorinoH-Index: 30
#2Paolo ChiodiniH-Index: 39
Last. Dario GiuglianoH-Index: 79
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10 CitationsSource
#1Melanie J. Davies (University of Leicester)H-Index: 82
#2David A. D'Alessio (Duke University)H-Index: 71
Last. John B. Buse (UNC: University of North Carolina at Chapel Hill)H-Index: 97
view all 10 authors...
The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the prior position statements, published in 2012 and 2015, on the management of type 2 diabetes in adults. A systematic evaluation of the literature since 2014 informed new recommendations. These include additional focus on lifestyle management and diabetes self-management education and support. For those with obesity, efforts targeting weight loss, including lifestyle, medication ...
258 CitationsSource
13 CitationsSource
#1Sultan LinjawiH-Index: 5
#2Bruce W. BodeH-Index: 49
Last. Richard W Simpson (Monash University)H-Index: 10
view all 8 authors...
Introduction The progressive nature of type 2 diabetes necessitates treatment intensification. This often involves intensification with oral antidiabetic drugs (OADs) initially, followed by other agents, such as glucagon-like peptide-1 receptor agonists (GLP-1RAs), with the majority of patients eventually requiring insulin therapy. Therefore, this trial aimed to investigate the efficacy of IDegLira (combination of insulin degludec and liraglutide) in controlling glycemia in adults with type 2 di...
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#1Amiel Stephanie AH-Index: 49
#2Pablo AschnerH-Index: 5
Last. Sophia Zoungas (Monash University)H-Index: 46
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86 CitationsSource
#1Julio RosenstockH-Index: 113
#2Ronnie AronsonH-Index: 17
Last. Melanie J. Davies (University of Leicester)H-Index: 82
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OBJECTIVE To evaluate efficacy and safety of LixiLan (iGlarLixi), a novel titratable fixed-ratio combination of insulin glargine (iGlar) and lixisenatide (Lixi), compared with both components, iGlar and Lixi, given separately in type 2 diabetes inadequately controlled on metformin with or without a second oral glucose-lowering drug. RESEARCH DESIGN AND METHODS After a 4-week run-in to optimize metformin and stop other oral antidiabetic drugs, participants ( N = 1,170, mean diabetes duration ∼8.8...
87 CitationsSource
#1Vanita R. Aroda (MedStar Health)H-Index: 20
#2Julio RosenstockH-Index: 113
Last. Richard M. BergenstalH-Index: 60
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84 CitationsSource
#1Vanita R. Aroda (Memorial Hospital of South Bend)H-Index: 14
#2Timothy S. BaileyH-Index: 25
Last. Athena Philis-TsimikasH-Index: 21
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Aim To evaluate the efficacy and safety of adding insulin degludec (IDeg) to treatment in patients with type 2 diabetes receiving liraglutide and metformin and qualifying for treatment intensification because of inadequate glycaemic control. Methods In this 26-week, double-blind trial, patients who still had inadequate glycaemic control after a 15-week run-in period with initiation and dose escalation of liraglutide to 1.8 mg in combination with metformin (≥1500 mg) were randomized to addition o...
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#1S. Del Prato (UniPi: University of Pisa)H-Index: 70
#2Juan P. FriasH-Index: 20
Last. Minzhi LiuH-Index: 1
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AIMS: beta-cell function declines over time in type 2 diabetes (T2D), thus efficacy of iGlarLixi by C-peptide levels and duration of diabetes was evaluated in an exploratory analysis of the LixiLan-G study. METHODS: LixiLan-G was a 26-week, randomized, open-label study in adults with T2D inadequately controlled while on glucagon-like peptide 1 receptor agonist (GLP-1 RA), with metformin, with/without pioglitazone and/or a sodium-glucose cotransporter 2 inhibitor. This analysis investigated the e...
Source
#1Martin HaluzikH-Index: 1
#2Milan Flekač (Charles University in Prague)H-Index: 4
Last. Péter Kempler (Semmelweis University)H-Index: 26
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The fixed-ratio combination (FRC) of a basal insulin and a GLP-1 receptor agonist (GLP-1 RA) has proven to be an effective therapeutic approach. However, physicians face numerous practical questions that cannot be answered by recently published trial results, current guidelines and summaries of product characteristics. In April 2019, a scientific meeting was held with the participation of nine experts from four Central and Eastern European countries to provide expert consensus on the optimal dai...
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