Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes

Lingvay, Ildiko; Manghi, Federico Pérez; García-Hernández, Pedro Alberto; Norwood, Paul; Lehmann, Lucine; Tarp-Johansen, Mads Jeppe; Buse, John B.

doi:10.1001/jama.2016.1252

Cited by 188 publications

(328 citation statements)

References 17 publications

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“…Comparative benefits of combination of basal insulin with GLP-1 RA as a single injection versus iGlar titration in basal insulin-treated patients with type 2 diabetes have also been reported in the Dual Action of Liraglutide and Insulin Degludec (DUAL) V trial, which examined the efficacy of IDegLira, a single injection combination of insulin degludec and the GLP-1 RA liraglutide (17). In both LixiLan-L and DUAL V, greater HbA 1c reductions and a greater proportion of patients reaching glycemic targets were achieved with the combination of basal insulin with GLP-1 RA (iGlarLixi and IDegLira, respectively) compared with titration of iGlar.…”

Section: Discussionmentioning

confidence: 82%

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial

et al. 2016

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OBJECTIVEThis study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucoselowering agents. RESEARCH DESIGN AND METHODSAfter a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m 2 ) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum dose of 60 units/day. The primary outcome was change in HbA 1c levels at 30 weeks. RESULTSHbA 1c decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA 1c from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA 1c of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA 1c <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (£70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi. CONCLUSIONSCompared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.

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Section: Discussionmentioning

confidence: 82%

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial

et al. 2016

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“…The FPG at baseline was 7.3/ 7.4 mmol/L in one trial [6], whereas baseline FPG values ranged from 8.9 to 9.9 mmol/L in the other two IGlarLixi trials [3,4] and all the IDegLira trials [2,5,[7][8][9]. Furthermore, the target FPG was 4.4-5.6 mmol/L in all the IGlarLixi trials, whereas it was 4.0-5.0 mmol/L in all but one of the IDegLira trials.…”

Section: Heterogeneity Of the Included Studiesmentioning

confidence: 94%

“…no maximum dose specified, as was the case with the basal insulin in two of three IDegLira comparisons with insulin) with those between an FRC and a capped insulin comparator (as was the case with glargine in two of three IGlarLixi comparisons with insulin). As seen in the DUAL II (capped) [5] and DUAL V (uncapped) [8] trials, end-of-trial differences in HbA 1c and fasting plasma glucose (FPG) favoring the FRC were larger, and the weight benefit was smaller, when the insulin dose was capped in the comparator arm. As a consequence, comparing results across trials, not taking these differences into account, will not reflect the true similarity or difference between regimens.…”

Section: Heterogeneity Of the Included Studiesmentioning

confidence: 99%

Methodological concerns with the meta-analysis comparing insulin degludec/liraglutide and insulin glargine/lixisenatide

Eggert

Zimmermann

Begtrup

2018

Expert Opinion on Pharmacotherapy

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“…Терапевтическая эффективность ИДегЛира в качестве дополнительной терапии при неэффективности перо-ральных сахароснижающих препаратов или других аго-нистов рецепторов ГПП-1 или базального инсулина изу-чалась в ходе 7 клинических рандомизированных муль-тинациональных исследований III фазы: DUAL-I [11], -II [6], -III [19], -IV [26], -V [18], -VI [14], -VII [5], а также в течение 26 недель продления исследования DUAL-I [12].…”

Section: терапевтическая эффективность комбинации инсулин деглудек/лиunclassified

A review of the efficacy and safety of the finished fixed-ratio combination of insulin degludec and liraglutide in the treatment of type 2 diabetes mellitus

Pogorelova¹

2018

Med. sov.

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А.С. ПОГОРЕЛОВА, к.м.н. Университетская клиническая больница №2 Первого Московского государственного медицинского университета им. И.М. Сеченова ОБЗОР ЭФФЕКТИВНОСТИ И БЕЗОПАСНОСТИ ГОТОВОЙ ФИКСИРОВАННОЙ КОМБИНАЦИИ ИНСУЛИНА ДЕГЛУДЕК И ЛИРАГЛУТИДА ПРИ ЛЕЧЕНИИ САХАРНОГО ДИАБЕТА 2-ГО ТИПА В связи с растущей распространенностью и прогрессированием сахарного диабета (СД) 2-го типа продолжаются поиски оптимального лекарственного средства не только для достижения целевого уровня гликемического контроля, но и сниже-ния массы тела и риска гипогликемических состояний. В целях повышения приверженности к лечению разрабатываются новые комбинации сахароснижающих препаратов. По результатам исследований добавление однократной инъекции фиксированной комбинации инсулин деглудек/лираглутид эффективно в отношении гликемического контроля и снижения массы тела, в целом хорошо переносится пациентами и является предпочтительным у лиц с плохо контролируемым СД 2-го типа на терапии пероральными сахароснижащими средствами в адекватных дозах и/или агонистами рецепторов глюкагоноподобного пептида-1 и/или базальным инсулином в целях снижения риска гипогликемии, ассоциированной с инсулинотерапией. Ключевые слова: гликемический контроль, сахарный диабет, лираглутид, инсулин деглудек. A.S. POGORELOVA, University Clinical Hospital No.2 of I.M.Sechenov First Moscow State Medical University A REVIEW OF THE EFFICACY AND SAFETY OF THE FINISHED FIXED-RATIO COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUSDue to the growing prevalence and progression of type 2 diabetes mellitus (DM), the researchers continue the search for the optimal drug not only to achieve the target level of glycaemic control, but also to reduce body weight and the risk of hypoglycaemic conditions. The new combinations of hypoglycaemic drugs are being developed in order to increase adherence to treatment. The studies showed that the addition of a single injection of a fixed combination of insulin degloudec/liraglutide is effective for glycaemic control and weight loss, generally well tolerated by patients and is preferred in individuals with poorly controlled type 2 diabetes on oral hypoglycaemic agents at adequate doses and/or glucagon-like peptide-1 receptor agonists and/or basal insulin to reduce the risk of hypoglycemia associated with insulin therapy.

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Effect of Insulin Glargine Up-titration vs Insulin Degludec/Liraglutide on Glycated Hemoglobin Levels in Patients With Uncontrolled Type 2 Diabetes

Cited by 188 publications

References 17 publications

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial

Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial

Methodological concerns with the meta-analysis comparing insulin degludec/liraglutide and insulin glargine/lixisenatide

A review of the efficacy and safety of the finished fixed-ratio combination of insulin degludec and liraglutide in the treatment of type 2 diabetes mellitus

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