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Efficacy and safety of a single-pill combination of vildagliptin and metformin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial.

Odawara M, Yoshiki M, Sano M, Hamada I, Lukashevich V, Kothny W - Diabetes Ther (2015)

Bottom Line: The overall incidences of adverse events (AEs) were 43.5% in the vildagliptin/metformin SPC and 67.9% in the vildagliptin/placebo SPC group.There were no deaths or hypoglycemic events during the study.Switching Japanese patients with T2DM requiring treatment intensification, from vildagliptin monotherapy to a vildagliptin/metformin SPC (50/250 or 50/500 mg) was efficacious and safe, eliciting significant reduction in HbA1c without increased risk of hypoglycemia and weight gain.

View Article: PubMed Central - PubMed

Affiliation: The Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University, Tokyo, Japan, odawara@tokyo-med.ac.jp.

ABSTRACT

Introduction: The use of dipeptidyl peptidase-4 inhibitors in combination with metformin is increasing in Japanese patients with type 2 diabetes mellitus (T2DM), but no single-pill combination (SPC) is currently available in Japan. The objective of this study was to assess the efficacy and safety of vildagliptin/metformin SPC in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy.

Methods: This was a 14-week, randomized, double-blind, parallel-group, placebo-controlled trial. 171 patients with T2DM inadequately controlled [HbA1c (glycosylated hemoglobin) 7.0-10.0%] with vildagliptin 50 mg twice daily (bid) were randomized (2:1) to receive either a vildagliptin/metformin SPC (n = 115) or matching vildagliptin/placebo SPC (n = 56).

Results: Baseline demographics and background characteristics were generally comparable between the treatment groups. The change in HbA1c [mean ± standard error (SE)] was -0.8 ± 0.1% in the vildagliptin/metformin SPC (baseline HbA1c, 7.9 ± 0.1%) group and 0.1 ± 0.1% in the vildagliptin/placebo SPC (baseline HbA1c, 8.0 ± 0.1%) group, with a between-treatment difference of -1.0 ± 0.1% (P <0.001) in favor of the vildagliptin/metformin SPC group. The proportion of patients achieving target HbA1c <7.0% was significantly higher with vildagliptin/metformin SPC compared with vildagliptin/placebo SPC (45.8% vs. 13.5%, P <0.001). The overall incidences of adverse events (AEs) were 43.5% in the vildagliptin/metformin SPC and 67.9% in the vildagliptin/placebo SPC group. The incidences of serious AEs were low in both the treatment groups (0.9% vs. 3.6%, respectively). Body weight remained constant throughout the study in both the treatment groups. There were no deaths or hypoglycemic events during the study.

Conclusions: Switching Japanese patients with T2DM requiring treatment intensification, from vildagliptin monotherapy to a vildagliptin/metformin SPC (50/250 or 50/500 mg) was efficacious and safe, eliciting significant reduction in HbA1c without increased risk of hypoglycemia and weight gain.

No MeSH data available.


Related in: MedlinePlus

a Mean glycosylated hemoglobin (HbA1c %) by treatment and visit (full analysis set). b Adjusted mean change in HbA1c from baseline to endpoint (full analysis set). *P <0.001. BL baseline, EP endpoint, SE standard error, SPC single-pill combination
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Fig3: a Mean glycosylated hemoglobin (HbA1c %) by treatment and visit (full analysis set). b Adjusted mean change in HbA1c from baseline to endpoint (full analysis set). *P <0.001. BL baseline, EP endpoint, SE standard error, SPC single-pill combination

Mentions: The mean HbA1c change over 14 weeks is shown in Fig. 3a. After 2 weeks, the mean HbA1c levels were lower in all vilda/met groups compared with the vilda/placebo group. At week 14, a statistically significant between-treatment difference in (mean ± SE) HbA1c of −1.0 ± 0.1% (P <0.001), in favor of the vilda/met group was observed (both doses combined) (Table 2). Statistically significant reductions (P <0.001) in HbA1c from baseline were also observed for the vilda/met 50/250 mg bid and vilda/met 50/500 mg bid subgroups (Fig. 3b). The placebo-corrected difference for the change in HbA1c was −0.8% [95% confidence interval (CI) −1.0%, −0.6%] and −1.2% (95% CI −1.4%, −1.0%) in the vilda/met 50/250 and 50/500 mg subgroups, respectively.Fig. 3


Efficacy and safety of a single-pill combination of vildagliptin and metformin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial.

Odawara M, Yoshiki M, Sano M, Hamada I, Lukashevich V, Kothny W - Diabetes Ther (2015)

a Mean glycosylated hemoglobin (HbA1c %) by treatment and visit (full analysis set). b Adjusted mean change in HbA1c from baseline to endpoint (full analysis set). *P <0.001. BL baseline, EP endpoint, SE standard error, SPC single-pill combination
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Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4374075&req=5

Fig3: a Mean glycosylated hemoglobin (HbA1c %) by treatment and visit (full analysis set). b Adjusted mean change in HbA1c from baseline to endpoint (full analysis set). *P <0.001. BL baseline, EP endpoint, SE standard error, SPC single-pill combination
Mentions: The mean HbA1c change over 14 weeks is shown in Fig. 3a. After 2 weeks, the mean HbA1c levels were lower in all vilda/met groups compared with the vilda/placebo group. At week 14, a statistically significant between-treatment difference in (mean ± SE) HbA1c of −1.0 ± 0.1% (P <0.001), in favor of the vilda/met group was observed (both doses combined) (Table 2). Statistically significant reductions (P <0.001) in HbA1c from baseline were also observed for the vilda/met 50/250 mg bid and vilda/met 50/500 mg bid subgroups (Fig. 3b). The placebo-corrected difference for the change in HbA1c was −0.8% [95% confidence interval (CI) −1.0%, −0.6%] and −1.2% (95% CI −1.4%, −1.0%) in the vilda/met 50/250 and 50/500 mg subgroups, respectively.Fig. 3

Bottom Line: The overall incidences of adverse events (AEs) were 43.5% in the vildagliptin/metformin SPC and 67.9% in the vildagliptin/placebo SPC group.There were no deaths or hypoglycemic events during the study.Switching Japanese patients with T2DM requiring treatment intensification, from vildagliptin monotherapy to a vildagliptin/metformin SPC (50/250 or 50/500 mg) was efficacious and safe, eliciting significant reduction in HbA1c without increased risk of hypoglycemia and weight gain.

View Article: PubMed Central - PubMed

Affiliation: The Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University, Tokyo, Japan, odawara@tokyo-med.ac.jp.

ABSTRACT

Introduction: The use of dipeptidyl peptidase-4 inhibitors in combination with metformin is increasing in Japanese patients with type 2 diabetes mellitus (T2DM), but no single-pill combination (SPC) is currently available in Japan. The objective of this study was to assess the efficacy and safety of vildagliptin/metformin SPC in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy.

Methods: This was a 14-week, randomized, double-blind, parallel-group, placebo-controlled trial. 171 patients with T2DM inadequately controlled [HbA1c (glycosylated hemoglobin) 7.0-10.0%] with vildagliptin 50 mg twice daily (bid) were randomized (2:1) to receive either a vildagliptin/metformin SPC (n = 115) or matching vildagliptin/placebo SPC (n = 56).

Results: Baseline demographics and background characteristics were generally comparable between the treatment groups. The change in HbA1c [mean ± standard error (SE)] was -0.8 ± 0.1% in the vildagliptin/metformin SPC (baseline HbA1c, 7.9 ± 0.1%) group and 0.1 ± 0.1% in the vildagliptin/placebo SPC (baseline HbA1c, 8.0 ± 0.1%) group, with a between-treatment difference of -1.0 ± 0.1% (P <0.001) in favor of the vildagliptin/metformin SPC group. The proportion of patients achieving target HbA1c <7.0% was significantly higher with vildagliptin/metformin SPC compared with vildagliptin/placebo SPC (45.8% vs. 13.5%, P <0.001). The overall incidences of adverse events (AEs) were 43.5% in the vildagliptin/metformin SPC and 67.9% in the vildagliptin/placebo SPC group. The incidences of serious AEs were low in both the treatment groups (0.9% vs. 3.6%, respectively). Body weight remained constant throughout the study in both the treatment groups. There were no deaths or hypoglycemic events during the study.

Conclusions: Switching Japanese patients with T2DM requiring treatment intensification, from vildagliptin monotherapy to a vildagliptin/metformin SPC (50/250 or 50/500 mg) was efficacious and safe, eliciting significant reduction in HbA1c without increased risk of hypoglycemia and weight gain.

No MeSH data available.


Related in: MedlinePlus