Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus

Iwamoto, Yasuhiko; Taniguchi, Tadaaki; Nonaka, Kenji; Okamoto, Taro; Okuyama, Kotoba; Ferreira, Juan Camilo Arjona; Amatruda, John M.

doi:10.1507/endocrj.k09e-272

Cited by 94 publications

(79 citation statements)

References 19 publications

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“…It was reported that sitagliptin 50 mg daily and 100 mg daily showed similar improvements in HbA1c [10]. On the other hand, a possible superiority of vildagliptin over other DPP-4 inhibitors regarding a hypoglycemic effect [11,12] was also reported.…”

Section: Discussionmentioning

confidence: 96%

Dipeptidyl Peptidase-4 Inhibitor Switching as an Alternative Add-on Therapy to Current Strategies Recommended by Guidelines: Analysis of a Retrospective Cohort of Type 2 Diabetic Patients

Tanaka¹,

Nishimura²,

Sekioka³

et al. 2016

J Diabetes Metab

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Objective: This retrospective cohort study aimed to investigate the significance of dipeptidyl peptidase-4 (DPP-4) inhibitor switch therapy, which is currently not recommended by major diabetes guidelines. Methods:The subjects were 238 outpatients with type 2 diabetes who had been prescribed sitagliptin 50 mg daily, which was subsequently changed in one of three ways. Patients whose sitagliptin was switched to vildagliptin 50 mg twice daily were defined as the switched group. Patients whose sitagliptin was increased to 100 mg once daily were defined as the increased group. Patients who received an additional alfa-glucosidase inhibitor (α-GI) three times daily prior to meals and sitagliptin 50 mg once daily were defined as the added group. The primary endpoint was the glycated hemoglobin (HbA1c) value at 6 months after the medication change. Patients whose oral hypoglycemic agents were changed within 6 months after switching to vildagliptin, increasing sitagliptin, or adding α-GI were excluded from the full analysis set and the remaining patients were included in the per protocol analysis. Results:The per protocol analysis revealed that the HbA1c level decreased significantly in the switched group (n=71) and the added group (n=18) but did not change significantly in the increased group (n=69). Analysis of the full set showed that the HbA1c level decreased significantly in all three groups (switched [n=92], increased [n=88], and added [n=25]).

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Section: Discussionmentioning

confidence: 96%

Dipeptidyl Peptidase-4 Inhibitor Switching as an Alternative Add-on Therapy to Current Strategies Recommended by Guidelines: Analysis of a Retrospective Cohort of Type 2 Diabetic Patients

Tanaka¹,

Nishimura²,

Sekioka³

et al. 2016

J Diabetes Metab

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“…While sitagliptin 50 mg/d is the standard initial dosage in Japan, which is increased to 100 mg/d in patients poorly controlled on the lower dosage, the present study was not conducted over a sufficiently long time frame to make this decision. It is likely that the PPG outcome data in the sitagliptin arm would have improved had the 100 mg/d dose level been used, because sitagliptin over the dose range of 25 to 100 mg/d is known to reduce 2‐hour PPG in a dose‐dependent manner relative to placebo 41. A future study with a larger scale and longer treatment period is required to determine how freedom from postprandial hyperglycaemia associated with lixisenatide affects HbA1c concentration.…”

Section: Discussionmentioning

confidence: 99%

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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“…Although the maximum allowable dose of sitagliptin in Japan is 100 mg daily, the degree of HbA1c reduction was shown not to differ between 50 mg and 100 or 200 mg in a Japanese clinical trial [14]. Thus, we used 50 mg of sitagliptin in the present study.…”

Section: Methodsmentioning

confidence: 99%

Effect of sitagliptin on glycemic control and beta cell function in Japanese patients given basal-supported oral therapy for type 2 diabetes

et al. 2014

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Dose-ranging efficacy of sitagliptin, a dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes mellitus

Cited by 94 publications

References 19 publications

Dipeptidyl Peptidase-4 Inhibitor Switching as an Alternative Add-on Therapy to Current Strategies Recommended by Guidelines: Analysis of a Retrospective Cohort of Type 2 Diabetic Patients

Dipeptidyl Peptidase-4 Inhibitor Switching as an Alternative Add-on Therapy to Current Strategies Recommended by Guidelines: Analysis of a Retrospective Cohort of Type 2 Diabetic Patients

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)

Effect of sitagliptin on glycemic control and beta cell function in Japanese patients given basal-supported oral therapy for type 2 diabetes

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