scholarly journals Effects of Additional Administration of a Selective Inhibitor of Sodium Glucose co-transporter-2 Inhibitor on the Glycemic Control in Japanese Type 2 Diabetes Mellitus Patients Receiving Treatment with a Dipeptidyl Peptidase-4 Inhibitor

Drug Research ◽  
2020 ◽  
Vol 70 (04) ◽  
pp. 131-136
Author(s):  
Masataka Kusunoki ◽  
Daisuke Sato ◽  
Takahiko Sakazaki ◽  
Tetsuro Miyata ◽  
Kazuhiko Tsutsumi ◽  
...  

AbstractWe conducted this study to determine whether additional administration sodium-glucose co-transporter 2 (SGLT2) inhibitor might provide further improvement of glycemic control and also to explore any advantages in Japanese type 2 diabetes patients showing relatively good glycemic control under treatment dipeptidyl peptidase-4 (DPP-4) inhibitors. We divided the patients in two groups, MT group and CT group. The MT group were continued on the DPP-4 inhibitor treatment for 6-months, and CT group were additionally administered an SGLT2 inhibitor treatment for 6-months. The MT group showed a significant decrease of hemoglobin A1c (HbA1c), but a significant increase of body weight, body mass index and serum uric acid, compared to the baseline values, while the CT group showed a significant decrease of HbA1c, body weight, BMI, and serum uric acid, and also a significant increase of serum HDL-cholesterol and decrease of serum triglyceride levels. Furthermore, this group showed a significant decrease of serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyl transpeptidase (γ-GTP), which are markers of liver function. These results suggest that the combination therapy is useful, in particular, for the treatment of type 2 diabetes mellitus patients with hyperlipidemia and liver dysfunction. Among the SGLT2 inhibitors added to the DPP-4 inhibitor treatment, the decreases of serum levels of AST, ALT and γ-GTP were particularly significant in the group receiving luseogliflozin, suggesting that the combination of a DPP-4 inhibitor with luseogliflozin is particularly effective for the treatment of type 2 diabetes mellitus patients with liver dysfunction.

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A331-A331
Author(s):  
Matthew J Budoff ◽  
Timothy M E Davis ◽  
Alexandra G Palmer ◽  
Robert Frederich ◽  
David E Lawrence ◽  
...  

Abstract Introduction: Ertugliflozin (ERTU), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is approved as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM). Aim: As a pre-specified sub-study of the Phase 3 VERTIS CV trial (NCT01986881), the efficacy and safety of ERTU were assessed in patients with T2DM and established atherosclerotic cardiovascular disease (ASCVD) inadequately controlled with metformin and sulfonylurea (SU). Methods: Patients with T2DM, established ASCVD, and HbA1c 7.0–10.5% on stable metformin (≥1500 mg/day) and SU doses as defined per protocol were randomized to once-daily ERTU (5 mg or 15 mg) or placebo. The primary sub-study objectives were to assess the effect of ERTU on HbA1c compared with placebo and to evaluate safety and tolerability during 18-week follow-up. Key secondary endpoints included proportion of patients achieving HbA1c <7%, fasting plasma glucose (FPG), body weight, and systolic blood pressure. Changes from baseline at Week 18 for continuous efficacy endpoints were assessed using a constrained longitudinal data analysis model. Results: Of the 8246 patients enrolled in the VERTIS CV trial, 330 patients were eligible for this sub-study (ERTU 5 mg, n=100; ERTU 15 mg, n=113; placebo, n=117). Patients had a mean (SD) age of 63.2 (8.4) years, T2DM duration 11.4 (7.4) years, estimated glomerular filtration rate 83.5 (17.8) mL/min/1.73 m2, and HbA1c 8.3% (1.0) (67.4 [10.6] mmol/mol). At Week 18, ERTU 5 mg and 15 mg were each associated with a significantly greater least squares mean (95% CI) HbA1c reduction from baseline versus placebo; the placebo-adjusted differences for ERTU 5 mg and 15 mg were –0.7% (–0.9, –0.4) and –0.8% (–1.0, –0.5), respectively (P<0.001). A higher proportion of patients in each ERTU group achieved HbA1c <7% relative to placebo (P<0.001). ERTU significantly reduced FPG and body weight (P<0.001, for each dose versus placebo), but not systolic blood pressure. Adverse events were reported in 48.0%, 54.9%, and 47.0% of patients in the ERTU 5 mg, 15 mg, and placebo groups, respectively. Genital mycotic infections were experienced by significantly higher proportions of male patients who received ERTU 5 mg and 15 mg (4.2% and 4.8%, respectively) versus placebo (0.0%; P≤0.05) and by a numerically, but not significantly, higher proportion of female patients who received ERTU 15 mg (10.3%) compared with placebo (3.8%) (P=0.36). The incidences of symptomatic hypoglycemia were 11.0% (5 mg), 12.4% (15 mg), and 7.7% (placebo), and of severe hypoglycemia 2.0% (5 mg), 1.8% (15 mg), and 0.9% (placebo). Conclusion: Among patients with T2DM and ASCVD, ERTU (5 mg and 15 mg) added to metformin and SU for 18 weeks improved glycemic control (HbA1c and FPG) and reduced body weight, and was generally well tolerated with a safety profile consistent with the SGLT2 inhibitor class.


2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
N. Papanas ◽  
M. Demetriou ◽  
N. Katsiki ◽  
K. Papatheodorou ◽  
D. Papazoglou ◽  
...  

The aim of this paper was to assess serum uric acid (SUA) levels in patients with type 2 diabetes mellitus (T2DM) with or without sudomotor dysfunction (evaluated by the Neuropad test). We included 36 T2DM patients with sudomotor dysfunction (group A: mean age63.1±2.6years) and 40 age-, gender-, renal function- and T2DM duration-matched patients without sudomotor dysfunction (group B: mean age62.1±3.1years). SUA was significantly higher in group A (P<0.001). There was a significant correlation between SUA and Neuropad time to colour change in both groups (group A:rs=0.819,P<0.001; group B:rs=0.774,P<0.001). There was also a significant positive correlation between SUA and CRP in both groups (group A:rs=0.947,P<0.001; group B:rs=0.848,P<0.001). In conclusion, SUA levels were higher in T2DM patients with sudomotor dysfunction than those without this complication. The potential role of SUA in sudomotor dysfunction merits further study.


Angiology ◽  
2011 ◽  
Vol 62 (4) ◽  
pp. 291-295 ◽  
Author(s):  
N. Papanas ◽  
N. Katsiki ◽  
K. Papatheodorou ◽  
M. Demetriou ◽  
D. Papazoglou ◽  
...  

2015 ◽  
Vol 18 (4) ◽  
pp. 87-91 ◽  
Author(s):  
Gagik Radikovich Galstyan ◽  
Svetlana Viktorovna Sergeeva

The evidence for DPP-4 inhibitors effectiveness at the late stages of type 2 diabetes mellitus (T2DM) are still growing. This is particularly important for those patients who receive insulin without adequately glycemic control. This publication provides the overview of studies which demonstrate high efficacy of Vildagliptin in reducing the blood glucose level in patients with hight duration of T2DM and insulin therapy. DPP-4 inhibitors normalize basal and postprandial glucagon secretion with pancreas α-cells that helps to provide better glycemic control and to reduce a risk of hypoglycemia. Besides, there are very interesting data for Vildagliptin to reduce insulin requirement in T2DM patients in addition to HbA1clevel decrease.


Author(s):  
Indu Verma ◽  
Archana Nimesh

Background and Aim: Uric acid is a pro-oxidant molecule that might be implicated in increasing oxidative stress and insulin resistance in type 2 diabetes mellitus patients. Hence, the aim of the study was to assess serum uric acid and HbA1c level (an indicator of glycemic control) in these patients and speculate the association between the two. Methods: 40 newly diagnosed cases of Type 2 diabetes mellitus (20 males and 20 females) with age ranging between 35-70 years were statistically compared against 40 age and sex-matched healthy subjects with respect to their uric acid and HbA1c levels. Demographic data like the height and weight of patients was also recorded and statistically compared. Results: No statistical difference in age, height and weight were observed in type 2 diabetes cases vs. controls indicating that the groups were comparable. HbA1c and uric acid levels of males and females with type 2 diabetes mellitus were significantly higher in comparison to normal males and females(controls). Correlation analysis showed a positive and significant correlation between HbA1c and uric acid levels in male and female cases of type 2 diabetes mellitus Conclusion: Uric acid might have a role in the development or worsening of type 2 diabetes mellitus. However, further studies are required with a larger sample size to clearly establish the relationship between uric acid and glycemic control in type 2 diabetes mellitus since studies in the literature have shown conflicting results and hence the understanding of the etiopathogenesis of type 2 diabetes mellitus remains poorly understood with respect to uric acid. Keywords: type 2 diabetes mellitus; uric acid, HbA1c; etiopathogenesis; correlation.


Drug Research ◽  
2018 ◽  
Vol 68 (12) ◽  
pp. 704-709 ◽  
Author(s):  
Masataka Kusunoki ◽  
Yukie Natsume ◽  
Tetsuro Miyata ◽  
Kazuhiko Tsutsumi ◽  
Yoshiharu Oshida

AbstractWe conducted this study to determine whether additional administration of a dipeptidyl peptidase-4 (DPP-4) inhibitor might provide further improvement of the glycemic control in Japanese type 2 diabetes patients showing relatively good glycemic control under treatment with a sodium glucose co-transporter 2 (SGLT2) inhibitor. Five SGLT2 inhibitor (luseogliflozin, dapagliflozin, tofogliflozin, empagliflozin and canagliflozin) preparations and five DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, anagliptin and linagliptin) preparations were used. The results showed that monotherapy with SGLT2 inhibitor produced significant decreases of the body weight and BMI, hemoglobin A1c (HbA1c) also decreased, but not to a significant extent. However, decreases of the serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyltransferase (γ-GTP) and uric acid were observed in this group. On the other hand, in type 2 diabetes patients treated concomitantly with a DPP-4 inhibitor and SGLT2 inhibitor, significant decrease of the HbA1c was observed, indicating the favorable effect of the concomitant therapy. The body weight and BMI decreased. As for the serum lipid profile, elevation of the serum HDL-cholesterol (HDL-C) was observed. Furthermore, AST, ALT, γ-GTP and uric acid decreased in the combined treatment group. Then, the therapeutic responses to concurrent administration with SGLT2 inhibitor of each of the 5 individual DPP-4 inhibitors used in this study were analyzed. The results showed that concomitant administration of sitagliptin, a DPP-4 inhibitor, with the SGLT2 inhibitor yielded the best results in terms of the lowering of the HbA1c and improvement of the serum lipid profile.


2012 ◽  
Vol 19 (4) ◽  
pp. 343-351
Author(s):  
Oana Albai ◽  
Bogdan Timar ◽  
Laura Diaconu ◽  
Romulus Timar

AbstractObjective: Despite the diversity of antidiabetic medication currently available, lessthan half of the patients with type 2 diabetes meet the therapeutic targetsrecommended by the guidelines: HbA1c <7%, or even <6.5%. This study aimed toinvestigate the efficacy and safety of sitagliptin in patients with type 2 diabetesmellitus, with inadequate glycemic control, as well as the effects on cardiovascularrisk factors. Material and method: The study included 348 patients, 161 men(46.3%) and 187 women (53.7%), with mean age of 56.1 ± 6.2 years, who startedtreatment with sitagliptin, combined with either metformin, sulphonylurea or both.Results and discussions: Sitagliptin improved glycemic control reducing averageHbA1c with 1.1%; the average weight decreased with 1.7 kg after 24 weeks oftreatment, and the lipid profile improved significantly. Conclusions: Sitagliptinoffers a new therapeutic option in patients with type 2 diabetes mellitus, with theadvantage of a single dose oral administration.


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