Efficacy and Safety of Vildagliptin as an Add-On Therapy in Inadequately Controlled Type 2 Diabetes Patients Treated With Basal Insulin

Saito, Daisuke; Kanazawa, Akio; Shigihara, Nayumi; Sato, Fumihiko; Uchida, Toyoyoshi; Sato, Junko; Goto, Hiromasa; Miyatsuka, Takeshi; Ikeda, Fuki; Ogihara, Takeshi; Ohmura, Chie

doi:10.14740/jocmr2874w

Cited by 5 publications

(4 citation statements)

References 19 publications

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“…Even though these results were obtained in a real-world clinical setting, they were consistent with a previous Japanese clinical trial [8]. Two other Japanese studies evaluating vildagliptin, used either in combination with insulin [17] or as addon to insulin and other OADs [18], also showed significant improvements in HbA1c over 12 weeks. Although the study designs (randomized, placebo-controlled) differ from the present study, all three studies are consistent in terms of improvement in HbA1c over time.…”

Section: Discussionsupporting

confidence: 88%

Safety and efficacy of vildagliptin: 52-week post-marketing surveillance of Japanese patients with type 2 diabetes in combination with other oral antidiabetics and insulin

Hayashi

Murayama

Shinfuku

et al. 2019

Expert Opinion on Pharmacotherapy

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Background: Vildagliptin is a dipeptidyl peptidase-4 inhibitor that reduces glycemia in patients with type 2 diabetes mellitus (T2DM). When approved in 2013, data on vildagliptin combined with >750 mg/ day metformin in Japanese patients were limited. There is a need to confirm the safety and efficacy of vildagliptin in combination with oral antidiabetic drugs (OADs). Research design and methods: This 52-week post-marketing surveillance (PMS) observational study in Japanese T2DM patients evaluated the safety and efficacy of vildagliptin in combination with OADs including high-dose metformin or insulin but excluding combination with sulfonylureas alone. Results: During this survey of 3006 Japanese T2DM patients, 13.61% of patients experienced adverse events (AEs) and 2.20% reported a serious AE (SAE). The frequency of AEs/SAEs was similar when in combination with biguanides (12.93%/1.46%), metformin ≥1000 mg/day (12.92%/1.22%), metformin <1000 mg/day (12.62%/1.54%), thiazolidine derivatives (16.71%/2.86%), α-glucosidase inhibitors (13.18%/1.90%), rapid-acting insulin secretagogues (glinides) (20.41%/5.71%), or insulin (15.87%/ 2.47%). The mean ± SD changes from baseline at endpoint in glycated hemoglobin and fasting blood glucose were −0.76 ± 1.27% and −23.3 ± 57.3 mg/dL, respectively, and these changes were consistent, regardless of concomitant OAD. Conclusions: Long-term vildagliptin combination therapy is safe and effective in Japanese T2DM patients in real-world settings.

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Section: Discussionsupporting

confidence: 88%

Safety and efficacy of vildagliptin: 52-week post-marketing surveillance of Japanese patients with type 2 diabetes in combination with other oral antidiabetics and insulin

Hayashi

Murayama

Shinfuku

et al. 2019

Expert Opinion on Pharmacotherapy

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“…These improvements are in good accord with those seen in Western populations treated with a combination of vildagliptin and insulin [ 39 , 40 ]. Our results were somewhat different to those obtained in a previous study of a Japanese population [ 41 ], which indicated that the HbA1c level in patients receiving vildagliptin add-on therapy was 1.0% lower. Compared to Western patients, Asian patients were found to have a lower BMI [ 42 , 43 ] and more visceral fat [ 44 ], and more Asian patients with diabetes had isolated postprandial hyperglycemia [ 45 ].…”

Section: Discussioncontrasting

confidence: 99%

Effects of Vildagliptin Add-on Insulin Therapy on Nocturnal Glycemic Variations in Uncontrolled Type 2 Diabetes

Shen

Sun

et al. 2017

Diabetes Ther

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IntroductionTo investigate whether vildagliptin add-on insulin therapy improves glycemic variations in patients with uncontrolled type 2 diabetes (T2D) compared to patients with placebo therapy.MethodsThis was a 24-week, single-center, double-blind, placebo-controlled trial. Inadequately controlled T2D patients treated with insulin therapy were recruited between June 2012 and April 2013. The trial included a 2-week screening period and a 24-week randomized period. Subjects were randomly assigned to a vildagliptin add-on insulin therapy group (n = 17) or a matched placebo group (n = 16). Scheduled visits occurred at weeks 4, 8, 12, 16, 20, and 24. Continuous glucose monitoring (CGM) was performed before and at the endpoint of the study.ResultsA total of 33 subjects were admitted, with 1 patient withdrawing from the placebo group. After 24 weeks of therapy, HbA1c values were significantly reduced at the endpoint in the vildagliptin add-on group. CGM data showed that patients with vildagliptin add-on therapy had a significantly lower 24-h mean glucose concentration and mean amplitude of glycemic excursion (MAGE). At the endpoint of the study, patients in the vildagliptin add-on group had a significantly lower MAGE and standard deviation compared to the control patients during the nocturnal period (0000–0600). A severe hypoglycemic episode was not observed in either group.ConclusionVildagliptin add-on therapy to insulin has the ability to improve glycemic variations, especially during the nocturnal time period, in patients with uncontrolled T2D.

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“…Other DPP-4 inhibitors have been evaluated in the treatment of Japanese patients with T2DM and, like linagliptin, have demonstrated favourable efficacy and safety profiles [17–23]. In the majority of these studies, the mean age was lower (approximately 60 years) than in the current study (71 years).…”

Section: Discussionmentioning

confidence: 75%

“…Studies undertaken with other DPP-4 inhibitors in the treatment of Japanese patients with T2DM show that these agents also exhibit good efficacy and safety profiles [17–23].…”

Section: Introductionmentioning

confidence: 99%

Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged ≥ 60 Years Treated with Basal Insulin: A Randomised Trial

et al. 2019

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IntroductionAn estimated 4.3 million people aged ≥ 65 years with diabetes live in Japan. We evaluated the efficacy and safety of linagliptin in older Japanese patients with poorly controlled type 2 diabetes (T2DM).MethodsIn this phase 4, randomised, placebo-controlled national study (part of a global study) conducted in Japan over a period of 52 weeks, 102 patients on stable treatment with basal insulin ± metformin/alpha-glucosidase inhibitors were randomised (1:1) to receive linagliptin 5 mg qd or placebo. The primary end point was the change in glycated haemoglobin (HbA1c) after 24 weeks of treatment, with additional analyses at 52 weeks.ResultsMean age and HbA1c of the study population were 71 years and 8.1%, respectively. Approximately two-thirds of participants were aged ≥ 70 years, two-thirds had macrovascular complications, approximately half had a baseline estimated glomerular filtration rate < 60 ml/min/1.73 m2, and two-thirds had a time since diagnosis of diabetes > 10 years. Significant HbA1c reductions with linagliptin vs. placebo were observed at 24 weeks, – 0.71% (95% CI − 0.96, − 0.45, p < 0.0001), and maintained at 52 weeks, – 0.58% (95% CI − 0.82, − 0.34, p < 0.0001). Linagliptin improved the chances of achieving a categorical HbA1c target (< 8.0% and < 7.0%) at 24 and 52 weeks in patients who were not at their respective target at the beginning of the study. Addition of linagliptin to insulin was associated with a numerical increase in the risk of any hypoglycaemia, but not in the risk of clinically significant hypoglycaemia, severe hypoglycaemia or recurring hypoglycaemia.ConclusionLinagliptin was effective in improving glucose control in Japanese patients aged ≥ 60 years with T2DM on stable glucose-lowering therapy with basal insulin. Linagliptin was well tolerated and no new safety concerns were raised. The results presented here are highly consistent with the results from the global study, which was conducted over a 24-week period.Trial RegistrationClinicalTrials.gov identifier, NCT02240680.FundingBoehringer Ingelheim and Eli Lilly and Company Diabetes Alliance.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-01065-7) contains supplementary material, which is available to authorized users.

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Efficacy and Safety of Vildagliptin as an Add-On Therapy in Inadequately Controlled Type 2 Diabetes Patients Treated With Basal Insulin

Cited by 5 publications

References 19 publications

Safety and efficacy of vildagliptin: 52-week post-marketing surveillance of Japanese patients with type 2 diabetes in combination with other oral antidiabetics and insulin

Safety and efficacy of vildagliptin: 52-week post-marketing surveillance of Japanese patients with type 2 diabetes in combination with other oral antidiabetics and insulin

Effects of Vildagliptin Add-on Insulin Therapy on Nocturnal Glycemic Variations in Uncontrolled Type 2 Diabetes

Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged ≥ 60 Years Treated with Basal Insulin: A Randomised Trial

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