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The efficacy of vildagliptin concomitant with insulin therapy in type 2 diabetic subjects.

Ito D, Inoue K, Kaneko K, Yanagisawa M, Sumita T, Ikegami Y, Awata T, Ishida H, Katayama S, Inukai K - J Clin Med Res (2015)

Bottom Line: In addition, body mass index exhibited a significant negative correlation with the efficacy of vildagliptin, i.e., ΔHbA1c.On the other hand, the 21 patients switched from 50 mg of sitagliptin to vildagliptin showed HbA1c decreases approaching 0.7%.Taking into consideration that twice-daily oral vildagliptin has already been reported to be advantageous in reducing postprandial hyperglycemia, this drug was suggested to be more effective in reducing HbA1c than sitagliptin under conditions in which it is used as a supplement to basal insulin, as in this study.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama 350-0495, Japan ; Division of Internal Medicine, Ogawa Red Cross Hospital, 1525, Ogawa, Ogawa-machi, Hiki, Saitama 355-0397, Japan.

ABSTRACT

Background: In Japan, dipeptidyl peptidase 4 (DPP4) inhibitors have become standard therapeutic agents for type 2 diabetes, and numbers of patients receiving insulin therapy combined with DPP4 inhibitors, which is a highly effective regimen, are increasing.

Methods: In this study, we evaluated the efficacy of vildagliptin administered at the dose of 100 mg twice daily in 57 patients with type 2 diabetes already receiving insulin treatment.

Results: The 36 patients who simply received add-on vildagliptin showed a 0.6% decrease in HbA1c levels, despite a marked insulin dose reduction, mainly bolus insulin, of approximately 8.3 units. In addition, body mass index exhibited a significant negative correlation with the efficacy of vildagliptin, i.e., ΔHbA1c. On the other hand, the 21 patients switched from 50 mg of sitagliptin to vildagliptin showed HbA1c decreases approaching 0.7%.

Conclusion: Taking into consideration that twice-daily oral vildagliptin has already been reported to be advantageous in reducing postprandial hyperglycemia, this drug was suggested to be more effective in reducing HbA1c than sitagliptin under conditions in which it is used as a supplement to basal insulin, as in this study.

No MeSH data available.


Related in: MedlinePlus

The changes in clinical parameters after 12 and 24 weeks in study 2: (a) HbA1c; (b) 2-h postprandial plasma glucose; (c) body weights; (d) insulin doses. *P < 0.05 compared with the baseline.
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Figure 3: The changes in clinical parameters after 12 and 24 weeks in study 2: (a) HbA1c; (b) 2-h postprandial plasma glucose; (c) body weights; (d) insulin doses. *P < 0.05 compared with the baseline.

Mentions: The clinical characteristics of the 57 enrolled patients at the start of the study are shown, separately for studies 1 and 2, in Table 1. The patients were being treated with insulin, and the duration of diabetes was at least 10 years. In addition, there was a tendency for obesity, with the mean BMI exceeding 25. Therefore, the mean total insulin dose was ≥ 30 units daily, which is considered to be high for Japanese patients. The study involved poorly controlled patients with a mean HbA1c level ≥ 8%. The results of study 1 are shown in Figure 2. In the vildagliptin add-on therapy group, the mean HbA1c level decreased from 8.1% to 7.5% (Fig. 2a) and, notably, the mean daily insulin dose could be reduced significantly, by 8.3 units (Fig. 2d). The mean dose of rapid acting insulin, i.e. bolus insulin, was reduced by 7.8 units (from 26.4 to 18.6 units), while that of basal insulin was reduced by 0.5 units (from 8.8 to 8.3 units). Thus, bolus insulin injected before meals accounted for most of the insulin dose reduction. The 2-h postprandial plasma glucose levels also decreased significantly (Fig. 2b). There were no significant changes in body weight (Fig. 2c) or 2-h postprandial plasma C-peptide levels. The results of study 2 are shown in Figure 3. After switching from sitagliptin to vildagliptin, the mean HbA1c level improved by 0.7%, down from 9.0%, despite almost no change in the insulin dose (Fig. 3a, d). The 2-h postprandial plasma glucose levels did not change (Fig. 3b), suggesting that mainly improvement and stabilization of fasting blood glucose levels had contributed to the significant improvement in HbA1c levels. Mean body weight increased significantly by 1.2 kg (Fig. 3c), but there was no significant change in 2-h plasma postprandial C-peptide levels. Figure 4 presents the relationships between the efficacy of vildagliptin, i.e., ΔHbA1c, and BMI and baseline HbA1c. BMI exhibited a significant negative correlation with ΔHbA1c in study 1, while no relationships were observed in study 2. Baseline HbA1c was strongly associated with ΔHbA1c in both studies. None of the patients were withdrawn from either study as there were no marked deteriorations of blood glucose levels. In study 1, two patients developed mild hypoglycemia, but there were no episodes of severe hypoglycemia. In addition, no safety problems were seen in any of the 57 patients.


The efficacy of vildagliptin concomitant with insulin therapy in type 2 diabetic subjects.

Ito D, Inoue K, Kaneko K, Yanagisawa M, Sumita T, Ikegami Y, Awata T, Ishida H, Katayama S, Inukai K - J Clin Med Res (2015)

The changes in clinical parameters after 12 and 24 weeks in study 2: (a) HbA1c; (b) 2-h postprandial plasma glucose; (c) body weights; (d) insulin doses. *P < 0.05 compared with the baseline.
© Copyright Policy - open access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4356089&req=5

Figure 3: The changes in clinical parameters after 12 and 24 weeks in study 2: (a) HbA1c; (b) 2-h postprandial plasma glucose; (c) body weights; (d) insulin doses. *P < 0.05 compared with the baseline.
Mentions: The clinical characteristics of the 57 enrolled patients at the start of the study are shown, separately for studies 1 and 2, in Table 1. The patients were being treated with insulin, and the duration of diabetes was at least 10 years. In addition, there was a tendency for obesity, with the mean BMI exceeding 25. Therefore, the mean total insulin dose was ≥ 30 units daily, which is considered to be high for Japanese patients. The study involved poorly controlled patients with a mean HbA1c level ≥ 8%. The results of study 1 are shown in Figure 2. In the vildagliptin add-on therapy group, the mean HbA1c level decreased from 8.1% to 7.5% (Fig. 2a) and, notably, the mean daily insulin dose could be reduced significantly, by 8.3 units (Fig. 2d). The mean dose of rapid acting insulin, i.e. bolus insulin, was reduced by 7.8 units (from 26.4 to 18.6 units), while that of basal insulin was reduced by 0.5 units (from 8.8 to 8.3 units). Thus, bolus insulin injected before meals accounted for most of the insulin dose reduction. The 2-h postprandial plasma glucose levels also decreased significantly (Fig. 2b). There were no significant changes in body weight (Fig. 2c) or 2-h postprandial plasma C-peptide levels. The results of study 2 are shown in Figure 3. After switching from sitagliptin to vildagliptin, the mean HbA1c level improved by 0.7%, down from 9.0%, despite almost no change in the insulin dose (Fig. 3a, d). The 2-h postprandial plasma glucose levels did not change (Fig. 3b), suggesting that mainly improvement and stabilization of fasting blood glucose levels had contributed to the significant improvement in HbA1c levels. Mean body weight increased significantly by 1.2 kg (Fig. 3c), but there was no significant change in 2-h plasma postprandial C-peptide levels. Figure 4 presents the relationships between the efficacy of vildagliptin, i.e., ΔHbA1c, and BMI and baseline HbA1c. BMI exhibited a significant negative correlation with ΔHbA1c in study 1, while no relationships were observed in study 2. Baseline HbA1c was strongly associated with ΔHbA1c in both studies. None of the patients were withdrawn from either study as there were no marked deteriorations of blood glucose levels. In study 1, two patients developed mild hypoglycemia, but there were no episodes of severe hypoglycemia. In addition, no safety problems were seen in any of the 57 patients.

Bottom Line: In addition, body mass index exhibited a significant negative correlation with the efficacy of vildagliptin, i.e., ΔHbA1c.On the other hand, the 21 patients switched from 50 mg of sitagliptin to vildagliptin showed HbA1c decreases approaching 0.7%.Taking into consideration that twice-daily oral vildagliptin has already been reported to be advantageous in reducing postprandial hyperglycemia, this drug was suggested to be more effective in reducing HbA1c than sitagliptin under conditions in which it is used as a supplement to basal insulin, as in this study.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Diabetes, Saitama Medical University, 38, Morohongo, Moroyama, Iruma-gun, Saitama 350-0495, Japan ; Division of Internal Medicine, Ogawa Red Cross Hospital, 1525, Ogawa, Ogawa-machi, Hiki, Saitama 355-0397, Japan.

ABSTRACT

Background: In Japan, dipeptidyl peptidase 4 (DPP4) inhibitors have become standard therapeutic agents for type 2 diabetes, and numbers of patients receiving insulin therapy combined with DPP4 inhibitors, which is a highly effective regimen, are increasing.

Methods: In this study, we evaluated the efficacy of vildagliptin administered at the dose of 100 mg twice daily in 57 patients with type 2 diabetes already receiving insulin treatment.

Results: The 36 patients who simply received add-on vildagliptin showed a 0.6% decrease in HbA1c levels, despite a marked insulin dose reduction, mainly bolus insulin, of approximately 8.3 units. In addition, body mass index exhibited a significant negative correlation with the efficacy of vildagliptin, i.e., ΔHbA1c. On the other hand, the 21 patients switched from 50 mg of sitagliptin to vildagliptin showed HbA1c decreases approaching 0.7%.

Conclusion: Taking into consideration that twice-daily oral vildagliptin has already been reported to be advantageous in reducing postprandial hyperglycemia, this drug was suggested to be more effective in reducing HbA1c than sitagliptin under conditions in which it is used as a supplement to basal insulin, as in this study.

No MeSH data available.


Related in: MedlinePlus