Serum level of soluble CD26/dipeptidyl peptidase-4 (DPP-4) predicts the response to sitagliptin, a DPP-4 inhibitor, in patients with type 2 diabetes controlled inadequately by metformin and/or sulfonylurea

Aso, Yoshimasa; Ozeki, Noriyuki; Terasawa, Tomoko; Naruse, Rika; Hara, Kenji; Suetsugu, Mariko; Takebayashi, Kohzo; Shibazaki, Mitsuei; Haruki, Kohsuke; Morita, Kimio; Iwamoto, Toshihiko

doi:10.1016/j.trsl.2011.09.005

Cited by 71 publications

(52 citation statements)

References 28 publications

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“…Kim et al [20] suggested that baseline BMI level might influence the glucose-lowering effect of DPP-4 inhibitors. Also a Japanese study revealed a significant correlation (r=0.419, p = 0.023) between baseline BMI and HbA1c level after 16 weeks of sitagliptin treatment in patients with type 2 diabetes and a BMI of 24.1 ± 5.0 kg/m 2 , which suggests that a lower BMI is a predictor of a good response to DPP-4 inhibitor [21]. However, these findings were not confirmed in our study.…”

Section: Safety and Tolerability Profilecontrasting

confidence: 90%

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes

et al. 2015

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Abstract. The aim of this study was to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes in a double-blind randomized placebo-controlled study. A total of 109 patients were randomized to 100 mg (n=37) or 200 mg (n=33) anagliptin twice daily or placebo (n=39). The primary objective was to alter HbA1c levels from baseline at a 24-week endpoint. The overall baseline mean age and body mass index were 56.20 ± 9.77 years and 25.01 ± 2.97 kg/m 2 , respectively, and the HbA1c level was of 7.14 ± 0.69 %. Anagliptin at 100 mg and 200 mg produced significant reductions in HbA1c (-0.50 ± 0.45 % and -0.51 ± 0.55%, respectively), and the placebo treatment resulted in an increase in HbA1c by 0.23 ± 0.62 %. Both doses of anagliptin produced significant decreases in fasting plasma glucose (-0.53 ± 1.25 mmol/L and -0.72 ± 1.25 mmol/L, respectively) and the proinsulin/insulin ratio (-0.04 ± 0.15 and -0.07 ± 0.18, respectively) compared with placebo. No meaningful body weight changes from baseline were observed in three groups. Plasma dipeptidyl peptidase (DPP)-4 activity was significantly inhibited after 24 weeks of anagliptin treatment, and >75% and >90% inhibitions were observed during the meal tolerance tests with 100 mg and 200 mg anagliptin, respectively. The incidences of adverse or serious adverse events were similar among the three study groups. Twice-daily anagliptin therapy effectively inhibited DPP-4 activity and improved glycemic control and was well-tolerated in patients with type 2 diabetes.

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Section: Safety and Tolerability Profilecontrasting

confidence: 90%

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes

et al. 2015

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“…There was no difference in body weight change from baseline between the Asian-and the nonAsian-dominant studies, which suggests that the baseline BMI might influence the glucose-lowering effect of DPP-4 inhibitors. In fact, a Japanese study revealed a significant correlation (r=0.419, p=0.0023) between baseline BMI and HbA 1c levels after 16 weeks of sitagliptin treatment in patients with type 2 diabetes and a BMI of 24.1±5.0 kg/m 2 [63], which suggests that a lower BMI is a predictor of a good response to a DPP-4 inhibitor. Collectively, the different BMIs among ethnic groups may contribute to the differences in the glucose-lowering response to DPP-4 inhibitors.…”

Section: Discussionmentioning

confidence: 97%

Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis

et al. 2013

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Aims/hypothesis The aim of this work was to compare the glucose-lowering efficacy of dipeptidyl peptidase-4 (DPP-4) inhibitors between Asian and non-Asian patients with type 2 diabetes. Methods We searched MEDLINE, EMBASE, LILACS, CENTRAL, ClinicalTrials.gov and conference proceedings. Studies were eligible if they were randomised controlled trials with a treatment duration of at least 12 weeks, compared a DPP-4 inhibitor with a placebo as either monotherapy or oral combination therapy, had information on ethnicity and HbA 1c values and were published or described in English. A systematic review and meta-analysis with a meta-regression analysis was conducted. Results Among 809 potentially relevant studies, 55 trials were included. A meta-analysis revealed that DPP-4 inhibitors lowered HbA 1c to a greater extent in studies with ≥50% Asian participants (weighted mean difference [WMD] −0.92%; 95% CI −1.03, −0.82) than in studies with <50% Asian participants (WMD −0.65%; 95% CI −0.69, −0.60). The between-group difference was −0.26% (95% CI −0.36, −0.17, p<0.001). The baseline BMI significantly correlated with the HbA 1c -lowering efficacy of DPP-4 inhibitors. The RR of achieving the goal of HbA 1c <7.0% (53.0 mmol/mol) was higher in studies with ≥50% Asian participants (3.4 [95% CI 2.6, 4.7] vs 1.9 [95% CI 1.8, 2.0]). The fasting plasma glucose-lowering efficacy was higher with monotherapy in the Asiandominant studies, but the postprandial glucose-lowering efficacy and changes in body weight were comparable between the two groups. Conclusions/interpretation DPP-4 inhibitors exhibit a better glucose-lowering efficacy in Asians than in other ethnic groups; this requires further investigation to understand the underlying mechanism, particularly in relation to BMI.

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“…24,25 During follow-up period in our study, there was one case (0.74%) of hypoglycemic event ( < 70 ㎎/ ㎗) who were co-prescribed with basal insulin.…”

Section: Discussionmentioning

confidence: 65%

Predictive Factors for the Therapeutic Response to Concomitant Treatment with DPP-4 Inhibitors in Type 2 Diabetes with Short-Term Follow-Up

Baek

Kim

Hong

et al. 2016

KMJ

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Type 2 diabetes mellitus (T2DM) has characteristics of insulin resistance with impaired hyperglycemia. Incretin effect, oral glucose loading induced a greater insulin secretion response than that of an isoglycemic intravenous glucose infusion, had lead us to recognize the glucose lowering effect of gut hormones; glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).1 These incretins are rapidly degraded by Objectives: To evaluate the efficacy and predictive factors of Dipeptidyl peptidase-4 (DPP-4) inhibitors in type 2 diabetes mellitus (T2DM) patients who were not well controlled with other oral antidiabetic drugs or insulin in real clinical practice. Methods: From December 2012 to January 2014, retrospective longitudinal observation study was conducted for patients with T2DM who were not reached a glycemic target (glycated hemoglobin [HbA1c] > 6.5%) with other oral antidiabetic drugs or insulins. Type 1 diabetes or other types of diabetes were excluded. Responders were eligible with decreased HbA1c from baseline for more than 5% during follow up period. Results: Of total 135 T2DM patients having an average 9.0 months follow-up period, 84 (62.2%) of patients were responder to DPP-4 inhibitors. After concomitant treatment with DPP-4 inhibitors, patients had a mean decrease in HbA1c of 0.69 ± 1.3%, fasting plasma glucose of 13 ± 52 ㎎/㎗, and postprandial plasma glucose of 29 ± 85 ㎎/㎗ from baseline (all P < 0.05). Independent predictive factor for an improvement of glycemic control with DPP-4 inhibitors was higher baseline HbA1c (odds ratio 2.07 with 95% confidence interval 1.15-3.72) compared with non-responders. Conclusions: A clinical meaningful improvement in glycemic control was seen when DPP-4 inhibitors were added to other anti-diabetic medications in patients with T2DM regardless of age, duration of T2DM, type of combination treatment regimen. Patients who had higher HbA1c were more easily respond to DPP-4 inhibitors treatment in short-term follow-up period.

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Serum level of soluble CD26/dipeptidyl peptidase-4 (DPP-4) predicts the response to sitagliptin, a DPP-4 inhibitor, in patients with type 2 diabetes controlled inadequately by metformin and/or sulfonylurea

Cited by 71 publications

References 28 publications

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes

Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis

Predictive Factors for the Therapeutic Response to Concomitant Treatment with DPP-4 Inhibitors in Type 2 Diabetes with Short-Term Follow-Up

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Serum level of soluble CD26/dipeptidyl peptidase-4 (DPP-4) predicts the response to sitagliptin, a DPP-4 inhibitor, in patients with type 2 diabetes controlled inadequately by metformin and/or sulfonylurea

Cited by 71 publications

References 28 publications

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-na&iuml;ve patients with type 2 diabetes

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-na&iuml;ve patients with type 2 diabetes

Differences in the glucose-lowering efficacy of dipeptidyl peptidase-4 inhibitors between Asians and non-Asians: a systematic review and meta-analysis

Predictive Factors for the Therapeutic Response to Concomitant Treatment with DPP-4 Inhibitors in Type 2 Diabetes with Short-Term Follow-Up

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Product

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A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes

A randomized, placebo-controlled, double-blind, phase 3 trial to evaluate the efficacy and safety of anagliptin in drug-naïve patients with type 2 diabetes