Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in Type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S)

Rosenstock, Julio; Hanefeld, Markolf; Shamanna, Paramesh; Min, Kyung Up; Bóka, G.; Miossec, P.; Zhou, Tianyue; Muehlen-Bartmer, Isabel; Ratner, Robert E.

doi:10.1016/j.jdiacomp.2014.01.012

Cited by 113 publications

(183 citation statements)

References 23 publications

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“…Overall, a low risk of hypoglycemia and no unexpected safety concerns were revealed. Lixisenatide demonstrated clinical efficacy with a favorable tolerability profile both as monotherapy and in combination with OADs and/or basal insulin in the phase III GetGoal clinical trial program (29)(30)(31)(32)(33)(34). The relative contribution of PPG is higher than FPG in older patients; thus, agents such as lixisenatide that preferentially lower postprandial hypoglycemia may be more effective in achieving glycemic goals without increasing the risk of hypoglycemia in these patients (3).…”

Section: Discussionmentioning

confidence: 99%

Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial

Meneilly

Roy-Duval

Alawi³

et al. 2017

Diabetes Care

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OBJECTIVETo evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment. RESEARCH DESIGN AND METHODSIn this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ‡70 years were randomized to receive once-daily lixisenatide 20 mg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks. Patients at risk for malnutrition or with moderate to severe cognitive impairment were excluded. The primary end point was absolute change in HbA 1c from baseline to week 24. Secondary end points included change from baseline to week 24 in 2-h postprandial plasma glucose (PPG) and body weight. RESULTSA total of 350 patients were randomized. HbA 1c decreased substantially with lixisenatide (20.57% [6.2 mmol/mol]) compared with placebo (+0.06% [0.7 mmol/mol]) from baseline to week 24 (P < 0.0001). Mean reduction in 2-h PPG was significantly greater with lixisenatide (25.12 mmol/L) than with placebo (20.07 mmol/L; P < 0.0001). A greater decrease in body weight was observed with lixisenatide (21.47 kg) versus placebo (20.16 kg; P < 0.0001). The safety profile of lixisenatide in this older population, including rates of nausea and vomiting, was consistent with that observed in other lixisenatide studies. Hypoglycemia was reported in 17.6% of patients with lixisenatide versus 10.3% with placebo. CONCLUSIONSIn nonfrail older patients uncontrolled on their current antidiabetic treatment, lixisenatide was superior to placebo in HbA 1c reduction and in targeting postprandial hyperglycemia, with no unexpected safety findings.

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Section: Discussionmentioning

confidence: 99%

Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial

Meneilly

Roy-Duval

Alawi³

et al. 2017

Diabetes Care

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“…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: 88%

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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“…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%

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%

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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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Beneficial effects of once-daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in Type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal-S)

Abstract: Once-daily lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks.

Cited by 113 publications

References 23 publications

Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial

Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial

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

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