Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double‐blind, placebo‐controlled, 24‐week trial (GetGoal‐M‐Asia)

Pan, Chang Yu; Han, Ping; Liu, Xiaoming; Yan, Shushan; Feng, Ping; Zhou, Zhiguang; Lv, Xiaoyi; Tian, Hui; Kui, Yang Jin; Su, Benli; Shang, Shuhua; Niemoeller, Elisabeth

doi:10.1002/dmrr.2541

Cited by 59 publications

(75 citation statements)

References 37 publications

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“…Randomization was stratified by sulphonylurea use at screening. Similar to other studies of lixisenatide in Asian patients,28, 30 lixisenatide was titrated in a stepwise manner to 20 µg once daily. Patients initially received a once‐daily subcutaneous injection of 10 µg, which increased weekly by 5 up to 20 µg once daily.…”

Section: Methodsmentioning

confidence: 95%

“…Lixisenatide was associated with a pronounced improvement in postprandial hyperglycaemia compared with placebo in these studies,25, 26, 27, 29 including studies in Asian patients exclusively 28, 30. Further, lixisenatide had a greater postprandial effect on blood glucose levels than the longer‐acting GLP‐1 receptor agonist liraglutide in patients with T2D insufficiently controlled on metformin, with or without insulin glargine 31, 32…”

Section: Introductionmentioning

confidence: 86%

“…Lixisenatide is a short‐acting GLP‐1 receptor agonist confirmed to improve glycaemic control when taken once daily in patients with T2D as monotherapy24 and in those insufficiently controlled on a range of antidiabetic background therapies, including metformin, a sulphonylurea, and/or insulin glargine, in combination with diet and exercise 25, 26, 27, 28, 29, 30. Lixisenatide was associated with a pronounced improvement in postprandial hyperglycaemia compared with placebo in these studies,25, 26, 27, 29 including studies in Asian patients exclusively 28, 30.…”

Section: Introductionmentioning

confidence: 99%

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Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study)

Yamada

Senda

Naito

et al. 2017

Diabetes Obesity Metabolism

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AimTo evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.Materials and methodsThis multicentre, open‐label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once‐daily oral sitagliptin 50 mg. The primary endpoint was the change in postprandial glucose (PPG) exposure 4 hours after a standardized breakfast (PPG area under the plasma glucose concentration–time curve [AUC0 :00‐4:00h]) from baseline to day 29.ResultsLixisenatide reduced PPG exposure to a statistically significantly greater extent than sitagliptin: least squares (LS) mean change from baseline in PPG AUC0 :00‐4:00h was −347.3 h·mg/dL (−19.3 h·mmol/L) in the lixisenatide group and −113.3 h·mg/dL (−6.3 h·mmol/L) in the sitagliptin group (LS mean between‐group difference −234.0 h·mg/dL [−13.0 h·mmol/L], 95% confidence interval −285.02 to −183.00 h·mg/dL [−15.8 to −10.2 h·mmol/L]; P < .0001). Lixisenatide led to significantly greater LS mean reductions in maximum PPG excursion than sitagliptin (−122.4 vs −46.6 mg/dL [−6.8 vs −2.6 h·mmol/L]; P < .0001). Change‐from‐baseline reductions in exposure to C‐peptide, fasting glycoalbumin levels, and the gastric emptying rate were greater in the lixisenatide than in the sitagliptin group. The incidence of treatment‐emergent adverse events was higher with lixisenatide (60.9%) than with sitagliptin (16.4%), with no serious events or severe hypoglycaemia reported.ConclusionLixisenatide reduced PPG significantly more than sitagliptin, when these agents were added to basal insulin glargine U100, and was well tolerated.

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Section: Methodsmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 86%

Section: Introductionmentioning

confidence: 99%

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Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study)

Yamada

Senda

Naito

et al. 2017

Diabetes Obesity Metabolism

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“…Lixisenatide (Lyxumia ® , Adlyxin ® ; Sanofi, Paris, France) is a once‐daily (QD), prandial, short‐acting GLP‐1 RA that has been evaluated extensively in the large, phase 3 GetGoal clinical trial program carried out in approximately 50 countries including Japan11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21. Treatment with lixisenatide monotherapy in patients with type 2 diabetes mellitus has shown improved glycemic control with reduced HbA1c, postprandial plasma glucose, fasting plasma glucose (FPG) and bodyweight, and has been shown to be well tolerated11, 12, 13.…”

Section: Introductionmentioning

confidence: 99%

“…Treatment with lixisenatide monotherapy in patients with type 2 diabetes mellitus has shown improved glycemic control with reduced HbA1c, postprandial plasma glucose, fasting plasma glucose (FPG) and bodyweight, and has been shown to be well tolerated11, 12, 13. Lixisenatide has also shown improved glycemic control as an add‐on treatment (including basal insulin with or without SU, metformin, metformin with or without SU, pioglitazone with or without metformin, and SU with or without metformin)12, 14, 15, 16, 17, 18, 19. More specifically, subanalyses of two randomized, placebo‐controlled studies in patients with type 2 diabetes mellitus, GetGoal‐S12 (lixisenatide add‐on to SU with or without metformin) and GetGoal‐L‐Asia (lixisenatide add‐on to basal insulin with or without SU)14, showed that lixisenatide treatment provided glycemic control (decreased HbA1c, FPG and postprandial plasma glucose), and was well tolerated in the Japanese subpopulation22, 23.…”

Section: Introductionmentioning

confidence: 99%

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open‐label, multicenter study

Seino

Terauchi

Wang

et al. 2017

J of Diabetes Invest

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Aim/IntroductionTo assess the overall safety of lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.Materials and MethodsPatients with type 2 diabetes mellitus, previously treated with ≤1 oral antidiabetic drug, were enrolled in an uncontrolled, open‐label, single‐arm study over 24 and 52 weeks. Any oral antidiabetic drug treatment was stopped at the start of the 6‐week run‐in period. From baseline, patients received once‐daily lixisenatide monotherapy (10 μg for 1 week, 15 μg for 1 week, 20 μg thereafter) for 52 weeks (first 140 patients enrolled) or 24 weeks (subsequently enrolled patients). The primary end‐point was safety over 24 and 52 weeks. Secondary efficacy end‐points included absolute change in glycated hemoglobin, fasting plasma glucose and bodyweight from baseline.ResultsOf 428 patients screened, 361 and 140 were treated for 24 and 52 weeks, respectively; 88.4 and 90.0% completed treatment. During the 24‐ and 52‐week treatment periods, 268/361 (74.2%) and 117/140 (83.6%) patients, respectively, had treatment‐emergent adverse events; the most frequently reported was nausea (33.2 and 31.4%, respectively). The risk of severe hypoglycemia was low; only one case was reported. Lixisenatide treatment resulted in a decrease in mean glycated hemoglobin A1c (−0.98 and −0.86%), fasting plasma glucose (−1.05 and −0.85 mmol/L), and bodyweight (−1.33 and −1.48 kg) for the 24‐ and 52‐week treatment periods, respectively.ConclusionsOnce‐daily lixisenatide monotherapy was associated with a safety profile in line with the glucagon‐like peptide‐1 receptor agonist class, and improved glycemic control in Japanese patients with type 2 diabetes mellitus.

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Lixisenatide reduces postprandial hyperglycaemia via gastrostatic and insulinotropic effects

Becker

Stechl

Steinstraesser

et al. 2015

Diabetes Metabolism Res

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BackgroundLixisenatide is a once‐daily, prandial, short‐acting glucagon‐like peptide‐1 receptor agonist. Its main antidiabetic effect is to delay gastric emptying to control postprandial plasma glucose excursions. The dose–response relationship of the integrated insulinotropic and gastrostatic response to lixisenatide in healthy volunteers after a standardized liquid meal was investigated.MethodsTwenty healthy subjects received acetaminophen 1000 mg with a standardized liquid meal 60 min after a single subcutaneous injection of placebo or lixisenatide 2.5, 5, 10 or 20 µg in randomized order separated by a 2‐ to 7‐day washout. Acetaminophen pharmacokinetics served as a surrogate to assess rate of gastric emptying. Postprandial plasma glucose, insulin, C‐peptide and glucagon were assessed for 5 h after the meal test, and lixisenatide pharmacokinetics were determined for 6 h.ResultsAfter lixisenatide administration and prior to the standardized meal, insulin and C‐peptide transiently increased, while fasting plasma glucose decreased in a dose‐dependent manner. After the meal, postprandial plasma glucose, insulin and C‐peptide were dose proportionally reduced with lixisenatide versus placebo for up to 6 h. Compared with placebo, glucagon levels were transiently lower after any lixisenatide dose, with more sustained reductions after the meal and no apparent dose‐related trends. Acetaminophen absorption was significantly reduced and delayed compared with placebo for lixisenatide doses ≥5 µg and demonstrated dose‐dependent slowing of gastric emptying. Lixisenatide displayed near dose‐proportional exposure, with gastrointestinal events increasing with dose.ConclusionsLixisenatide reduced fasting plasma glucose via stimulation of glucose‐dependent insulin release and controlled postprandial plasma glucose by delaying gastric emptying, demonstrating it to be a valuable option for overall glycaemic control. Copyright © 2015 John Wiley & Sons, Ltd.

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Lixisenatide treatment improves glycaemic control in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin with or without sulfonylurea: a randomized, double‐blind, placebo‐controlled, 24‐week trial (GetGoal‐M‐Asia)

Abstract: Background This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.

Cited by 59 publications

References 37 publications

Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study)

Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study)

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open‐label, multicenter study

Lixisenatide reduces postprandial hyperglycaemia via gastrostatic and insulinotropic effects

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