Efficacy and safety of liraglutide monotherapy compared with metformin in Japanese overweight/obese patients with type 2 diabetes

Tanaka, Kumiko; Saisho, Yoshifumi; Kawai, Takeshi; Tanaka, Masami; Meguro, Shu; Irie, Junichiro; Imai, Takatoshi; Shigihara, Toshikatsu; Morimoto, Jiro; Yajima, Ken; Atsumi, Yoshihito; Takei, Izumi; Itoh, Hiroshi

doi:10.1507/endocrj.ej14-0602

Cited by 21 publications

(18 citation statements)

References 39 publications

(44 reference statements)

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“…Consistent with our findings, in another exploratory study, the authors did not find any significant effect of 6 months of treatment with liraglutide on pancreatic volume using computer tomography imaging. 27 We found increased concentrations of lipase and amylase following treatment with liraglutide, which is in agreement with previous studies where both amylase and lipase have been consistently reported to increase after weeks of treatment. 8,13,14 However, controversies do exist regarding the acute effects (minutes to hour) of GLP-1/GLP-1RAs on pancreatic enzymes.…”

Section: Adverse Eventssupporting

confidence: 93%

No effects of a 6‐week intervention with a glucagon‐like peptide‐1 receptor agonist on pancreatic volume and oedema in obese men without diabetes

Svane

Johannesen

Martinussen

et al. 2020

Diabetes Obesity Metabolism

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Aim To investigate the effect of a glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), liraglutide, on pancreatic volume, oedema, cellularity and DNA synthesis in humans. Materials and Methods We performed an open‐label study in 14 obese men (age 38 ± 11 years, body mass index 32 ± 4 kg/m2) without diabetes. Subjects were examined at baseline, during titration (week 4) of liraglutide towards 3.0 mg/day, and 2 weeks after steady‐state treatment (week 6) of a final dose of liraglutide. The primary endpoint was pancreatic volume determined by magnetic resonance imaging. Secondary endpoints included pancreatic oedema and cellularity, positron emission tomography‐based [18F]fluorothymidine (FLT) uptake (DNA synthesis) and plasma pancreatic enzymes. Results Plasma amylase (+7 U/L [95% confidence intervals 3‐11], P < .01) and lipase (+19 U/L [7‐30], P < .01) increased during liraglutide treatment. Pancreatic volume did not change from baseline to steady state of treatment (+0.2 cm3 [−8‐8], P = .96) and no change in pancreatic cellular infiltration was found (P = .22). During titration of liraglutide, FLT uptake in pancreatic tissue increased numerically (+0.08 [0.00‐0.17], P = .0507). Conclusions Six weeks of treatment with liraglutide did not affect pancreatic volume, oedema or cellularity in obese men without diabetes.

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Section: Adverse Eventssupporting

confidence: 93%

No effects of a 6‐week intervention with a glucagon‐like peptide‐1 receptor agonist on pancreatic volume and oedema in obese men without diabetes

Svane

Johannesen

Martinussen

et al. 2020

Diabetes Obesity Metabolism

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“…In a monotherapy study in Japanese patients with type 2 diabetes mellitus who were defined as overweight or obese, liraglutide treatment (0.9 mg/day) at 24 weeks resulted in a decrease in HbA1c from 7.7 to 6.9% and a weight change (standard deviation) of −0.3 kg (1.9). Furthermore, 59.1% of patients achieved the HbA1c target level of <7%, and there were no reported cases of severe hypoglycemia33. In another Japanese cohort study, liraglutide monotherapy (0.9 mg/day) was an effective treatment for patients with type 2 diabetes mellitus inadequately controlled by diet therapy and/or OADs: 24‐week treatment with liraglutide monotherapy resulted in a decrease in HbA1c from 8.87 to 6.99%, and a 0.92‐kg weight reduction with 49.0% of patients reaching the American Diabetes Association target level of <7%34.…”

Section: Discussionmentioning

confidence: 94%

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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“…Thus, 19 potential studies were identified for the final analysis. However, ten of them were excluded for the following reasons: six studies did not provide outcome of interest or available data303132333435, two studies had liraglutide and metformin in both groups3637, one study was a sing-arm design38, and one study39 had overlap data with another trial40. Finally, nine RCTs192040414243444546 met the inclusion criteria, and were included in this meta-analysis.…”

Section: Resultsmentioning

confidence: 99%

The efficacy and safety of liraglutide added to metformin in patients with diabetes: a meta-analysis of randomized controlled trials

Meng

Guo

et al. 2016

Sci Rep

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Liraglutide, a glucagon-like peptide (GLP-1) receptor agonist, has showed favorable effects in the glycaemic control and weight reduction in patients with type 2 diabetes mellitus (T2DM). The meta-analysis was to compare the efficacy and safety of liraglutide added to metformin with other treatments in patients with T2DM. A systematic literature search on PubMed, Embase, Web of Science and the Cochrane library databases were performed. Eligible studies were randomized controlled trials (RCTs) of patients with T2DM who received the combination treatment of liraglutide and metformin. Pooled estimates were performed using a fixed-effects model or random-effects model. A total of nine RCTs met the inclusion criteria. Compared with control (placebo, sitagliptin, glimepiride, dulaglutide, insulin glargine, and NPH), liraglutide in combination with metformin resulted in significant reductions in HbA1c, bodyweight, FPG, and PPG, and similar reductions in SBP, and DBP. Moreover, liraglutide combined with metformin did not increase the risk of hypoglycemia, but induced a higher incidence of gastrointestinal disorders. In conclusion, this meta-analysis confirmed the use of liraglutide as add-on to metformin appeared to be effective and safe for patients with T2DM. However, considering the potential limitations in this study, more large-scale, well-conducted RCTs are needed to identify our findings.

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Efficacy and safety of liraglutide monotherapy compared with metformin in Japanese overweight/obese patients with type 2 diabetes

Cited by 21 publications

References 39 publications

No effects of a 6‐week intervention with a glucagon‐like peptide‐1 receptor agonist on pancreatic volume and oedema in obese men without diabetes

No effects of a 6‐week intervention with a glucagon‐like peptide‐1 receptor agonist on pancreatic volume and oedema in obese men without diabetes

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

The efficacy and safety of liraglutide added to metformin in patients with diabetes: a meta-analysis of randomized controlled trials

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