scholarly journals Potential Impact on Lipoprotein Subfractions in Type 2 Diabetes

2019 ◽  
Vol 12 ◽  
pp. 117955141986681 ◽  
Author(s):  
Yuka Kamijo ◽  
Hideto Ishii ◽  
Tomohiko Yamamoto ◽  
Kunihisa Kobayashi ◽  
Hiroyuki Asano ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Sglt2 Inhibitor ◽  
Density Lipoprotein ◽  
Hdl Cholesterol ◽  
Sglt2 Inhibitors ◽  
Diabetic Patients ◽  
Lipoprotein Subfractions ◽  
Cholesterol Levels

Introduction: Recently, the sodium-glucose cotransporter2 (SGLT2) inhibitor empagliflozin has been shown to lower cardiovascular risk among diabetic patients. It is intriguing that some SGLT2 inhibitors have been found to increase low-density lipoprotein (LDL) cholesterol levels, while the relevance to high-density lipoprotein (HDL) cholesterol is unknown. Although the inhibitory effect of SGLT2 inhibitors on glucose reabsorption may accelerate compensatory lipid metabolism and subsequently reduce body weight and affect the lipid profile, much remains unclear about this mechanism. Therefore, we conducted this study to investigate in detail how canagliflozin affects lipoprotein fractions including LDL and HDL subclasses. Materials and Methods: This study is a multicenter prospective study. The participants were patients with 22 type 2 diabetes (60.7 ± 11.6 years, 59.1% of men) who had HbA1c ⩾ 7.0% and consented to participate in the study. They were administered 100 mg canagliflozin orally once per day. Biochemistry test and cholesterol levels of 20 lipoprotein fractions (G1-G20) using high performance liquid chromatography methods were examined before and after 12 weeks of treatment period. Results: Significant decreases were observed in the participants’ body weight (69.7 to 67.9 kg, P < .001), systolic blood pressure (129.3 to 119.5 mm Hg, P < .01), and HbA1c (8.5% to 7.4%, P < .001). Cholesterol levels in the 20 lipoprotein fractions increased for very large HDL (G14, G15) and large HDL (G16) ( P < .05). Conclusions: Reduction in body weight, improvement of blood glucose levels, and increases in very large HDL and large HDL subclasses were observed after canagliflozin treatment. These beneficial changes might contribute to subsequent suppression of cardiovascular outcomes.

scholarly journals Association of high density lipoprotein levels with advancing age in type 2 diabetes patients in Tertiary Hospital.

2019 ◽  
Vol 26 (09) ◽  
pp. 1471-1476
Author(s):  
Shahzad Alam Khan ◽  
Iqra Imtiaz
Keyword(s):  
Type 2 Diabetes ◽  
Density Lipoprotein ◽  
Hdl Cholesterol ◽  
P Value ◽  
Diabetic Patients ◽  
Adverse Cardiovascular Event ◽  
Type 2 Diabetic Patients ◽  
Cross Sectional ◽  
Low Hdl

Background: HDL particles have several biological functions. Low levels of HDL-cholesterol are responsible for atherosclerotic disease. Type 2 diabetes is a metabolic disease of chronic etiology and low HDL‐cholesterol is frequent finding in diabetics. Levels of HDL with advancing age are inconsistent, few study show decline in HDL with increasing age while others show vice versa results. Objectives: Objective of this study was to establish an association between low HDL levels with advancing age in type 2 diabetic patients. Study Design: Cross sectional descriptive study. Setting: Diabetes Outpatient Department Nishtar Hospital Multan. Period: 6 months extending from March 2018 to August 2018. Materials and Methods: 145 patients with newly or previously diagnosed type 2 diabetes mellitus, age >35 years were considered for the study. Those diabetics who had family history of dyslipidemias (to rule out familial hyperlipidemias) were excluded. Study was started after acquiring permission from ethical committee. All the patients were evaluated for the HDL levels by getting a fasting lipid assay. Results: Out of 145 cases 78 (53.6%) were males while remaining 67 (46.4%) were female. Mean age of the patients was 57.27 + 6.91 years. Mean HDL level was 37.82 + 8.42. It was seen that HDL is low in 116/145 (80%) patients. Those diabetic patients who were < 60 (91 cases), HDL was noticed to be low in 67/91(73.62%) patients. Among patients >60 years (54 cases), HDL was identified to be low in 49/54(90.7%) patients. P-value was found out to be 0.012 Conclusion: Due to falling levels of HDL with advancing age in diabetic patients, there is increase in cardiovascular events in elderly diabetic patients. So the measures which tend to increase HDL level will also give protection against adverse cardiovascular event in elderly diabetics.

scholarly journals Effect of sodium–glucose co-transporter-2 inhibitors on the levels of serum asprosin in patients with newly diagnosed type 2 diabetes mellitus

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Aijun Jiang ◽  
Zhanrong Feng ◽  
Lu Yuan ◽  
Ying Zhang ◽  
Qian Li ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Body Weight ◽  
Placebo Group ◽  
Density Lipoprotein ◽  
Sglt2 Inhibitors ◽  
Newly Diagnosed ◽  
Lipid Levels

Abstract Background Asprosin, a novel adipokine that raises glucose levels and stimulates appetite, has been proved to be pathologically increased in populations predisposed to type 2 diabetes mellitus (T2DM), obesity, and cardiovascular diseases. The mechanisms of sodium-glucose co-transporter-2 (SGLT2) inhibitors for hypoglycemic effect and cardiovascular protection have not been fully clarified. Therefore, we conducted this study to assess change in the levels of serum asprosin after treatment with SGLT2 inhibitors in patients with newly diagnosed T2DM. Methods This study was a randomized, double-blind, placebo-controlled trial. A total of 29 participants with newly diagnosed T2DM with body mass index (BMI) ≥ 23.0 kg/m2 and haemoglobin A1c (HbA1c) levels of 58–85 mmol/mol (7.5–10%) were randomized to SGLT2 inhibitors dapagliflozin 10 mg/d (n = 19) or placebo (n = 10) treatment for 24 weeks. We analyzed asprosin concentrations by an enzyme-linked immunosorbent assay. Besides, body weight, BMI, HbA1c, fasting plasma glucose (FPG), and lipid levels were measured at baseline and 24 weeks. Results At 24 weeks, participants with SGLT2 inhibitors treatment exhibited lower levels of serum asprosin (22.87 vs 45.06 ng/ml in the placebo group; P < 0.001) after adjusting for baseline values. The levels of body weight, BMI, HbA1c, FPG, and triglyceride (TG) were decreased, while high density lipoprotein-cholesterol (HDL-C) was increased after SGLT2 inhibitors dapagliflozin treatment compared with placebo (P < 0.05 for all). Low density lipoprotein-cholesterol (LDL-C) and total cholesterol (TC) levels were unchanged in the SGLT2 inhibitors group and placebo group. No statistical correlation was found between the levels of serum asprosin and body weight, BMI, HbA1c, FPG, and lipid levels during the SGLT2 inhibitor dapagliflozin treatment. Conclusions These findings indicated that SGLT2 inhibitors can lower serum asprosin levels and improve glucolipid and weight in patients with newly diagnosed T2DM, which may benefit the cardiovascular system. Trial registration CTR20131268; Registered 20 March 2014 CTR20150102; Registered 03 March 2015. http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml.

scholarly journals Association of BMI and HDL Cholesterol in Relation to Glycated Albumin in Type 2 Diabetes Mellitus

2020 ◽  
Author(s):  
Suresh Babu Kondaveeti ◽  
Santosh Jagtap ◽  
Shilpa Kumar ◽  
Ankit Kumar Tiwari ◽  
Dipali Khopade ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Ldl Cholesterol ◽  
Glycated Albumin ◽  
Density Lipoprotein ◽  
Hdl Cholesterol ◽  
Diabetic Patients ◽  
Group 2 ◽  
Type 2 Diabetic ◽  
Group 1

Introduction: The main issue with the morbidity and mortality of type 2 diabetes is its associated health complications. In the last decade Glycated Albumin (GA) emerged as an extinguished marker for short-term glycaemic control. Aim: To Quadrate the association of Body Mass Index (BMI) along with HDL-cholesterol to GA in Type 2 diabetic cases. Materials and Methods: Total of 50 diabetic cases (Group 1) and 50 healthy non-diabetic control subjects (Group 2) recruited for the study between November 2017 to December 2018, which includes both males and females. Serum samples of both the groups were analysed to assess the lipid profile to GA levels along with BMI. Variations among groups was compared using student t-test by calculating r-values of the parametres and the pearson coefficient was calculated with significant p value at <0.05. Results: The levels of High-Density Lipoprotein (HDL) cholesterol in group 1 when compared with group 2 were significantly lower. Both BMI and GA showed negative correlation with HDL-C levels in both the groups. (p values 0.051 and 0.331 respectively). To boot, there was a statistically undeviating reciprocity of Low Density Lipoprotein (LDL) cholesterol to GA levels, BMI to LDL-cholesterol and BMI to Triglycerides (TG). There was a statistically significant correlation between GA and BMI (r=0.240, p<0.0001) and there was a statistically significant negative correlation between GA and HDL-cholesterol (r=-0.286, p<0.051) in diabetic patients (group 1). The association between GA and LDL-cholesterol (r=0.271, p<0.0001) was also been found statistically significant in group 1. Conclusion: The present study suggests that GA can be adapted as a reliable prospective biomarker that endures the potentiality in prognostication of serum lipid levels in diabetic patients and also BMI is the key formidable feature of dyslipidemia in type 2 diabetic cases.

scholarly journals Favorable pleiotropic effects of sodium glucose cotransporter 2 inhibitors: head-to-head comparisons with dipeptidyl peptidase-4 inhibitors in type 2 diabetes patients

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Shih-Chieh Shao ◽  
Kai-Cheng Chang ◽  
Swu-Jane Lin ◽  
Rong-Nan Chien ◽  
Ming-Jui Hung ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Sglt2 Inhibitor ◽  
Sglt2 Inhibitors ◽  
Pleiotropic Effects ◽  
Dipeptidyl Peptidase 4 ◽  
Dpp4 Inhibitors ◽  
Dpp4 Inhibitor ◽  
Diabetes Patients

Abstract Background Sodium glucose cotransporter 2 (SGLT2) inhibitors have shown greater reductions of cardiovascular event risks than dipeptidyl peptidase-4 (DPP4) inhibitors, whereby possible mechanisms may involve the better pleiotropic effects of SGLT2 inhibitors. However, no published data are currently available to directly compare glycemic and pleiotropic effects in real-world type 2 diabetes patients initiating SGLT2 inhibitors or DPP4 inhibitors. Method We conducted a retrospective cohort study by analyzing the Chang Gung Research Database, the largest multi-institutional electronic medical records database in Taiwan. We included patients newly receiving SGLT2 inhibitor or DPP4 inhibitor intensification therapy for type 2 diabetes from 2016 to 2017. We matched SGLT2 inhibitor users to DPP4 inhibitor users (1:4) by propensity scores to ensure comparable characteristics between the groups. We primarily evaluated 1-year post-treatment changes of hemoglobin A1c (HbA1c) after SGLT2 inhibitor or DPP4 inhibitor initiation, using two-tailed independent t-test. We also evaluated post-treatment changes in body weight, systolic blood pressure (SBP), alanine aminotransferase (ALT) and estimated glomerular filtration rate (eGFR) values, associated with SGLT2 inhibitors and DPP4 inhibitors. Results We identified a cohort of 2028 SGLT2 inhibitors and 8112 matched DPP4 inhibitors new users. SGLT2 inhibitors and DPP4 inhibitors showed similar HbA1c reductions (− 1.0 vs. − 1.1%; P = 0.076), but patients receiving SGLT2 inhibitors had greater improvements in body weight (− 1.5 vs. − 1.0 kg; P = 0.008), SBP (− 2.5 vs. − 0.7 mmHg; P < 0.001) and ALT values (− 4.1 vs. − 0.0 U/l; P < 0.001) and smaller declines in eGFR values (− 2.0 vs. − 3.5 ml/min/1.73 m2; P < 0.001) when compared to DPP4 inhibitors. Conclusion SGLT2 inhibitors had glucose-lowering effects comparable to those of DPP4 inhibitors but more favorable pleiotropic effects on body weight, ALT and eGFR changes, potentially improving type 2 diabetes patients’ cardio-metabolic disease risks.

scholarly journals Effect of sodium-glucose co-transporter-2 inhibitors on the levels of serum asprosin in patients with newly diagnosed type 2 diabetes mellitus

2021 ◽  
Author(s):  
Aijun Jiang ◽  
Zhanrong Feng ◽  
Lu Yuan ◽  
Ying Zhang ◽  
Qian Li ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Body Weight ◽  
Placebo Group ◽  
Density Lipoprotein ◽  
Sglt2 Inhibitors ◽  
Newly Diagnosed ◽  
Lipid Levels

Abstract Background: Asprosin, a novel adipokine that raises glucose levels and stimulates appetite, has been proved to be pathologically increased in populations predisposed to type 2 diabetes mellitus (T2DM), obesity, and cardiovascular diseases. The mechanisms of sodium-glucose co-transporter-2 (SGLT2) inhibitors for hypoglycemic effect and cardiovascular protection have not been fully clarified. Therefore, we conducted this study to assess change in the levels of serum asprosin after treatment with SGLT2 inhibitors in patients with newly diagnosed T2DM.Methods: This study was a randomized, double-blind, placebo-controlled trial. A total of 29 participants with newly diagnosed T2DM with body mass index (BMI)≥23.0 kg/m² and haemoglobin A1c (HbA1c) levels of 58~85 mmol/mol (7.5%~10%) were randomized to SGLT2 inhibitors dapagliflozin 10 mg/d (n=19) or placebo (n=10) treatment for 24 weeks. We analyzed asprosin concentrations by an enzyme-linked immunosorbent assay. Besides, body weight, BMI, HbA1c, fasting plasma glucose (FPG), and lipid levels were measured at baseline and 24 weeks. Results: At 24 weeks, participants with SGLT2 inhibitors treatment exhibited lower levels of serum asprosin (22.87 vs 45.06 ng/ml in the placebo group; P<0.001) after adjusting for baseline values. The levels of body weight, BMI, HbA1c, FPG, and triglyceride (TG) were decreased, while high density lipoprotein-cholesterol (HDL-C) was increased after SGLT2 inhibitors dapagliflozin treatment compared with placebo (P< 0.05 for all). Low density lipoprotein-cholesterol (LDL-C) and total cholesterol (TC) levels were unchanged in the SGLT2 inhibitors group and placebo group. No statistical correlation was found between the levels of serum asprosin and body weight, BMI, HbA1c, FPG, and lipid levels during the SGLT2 inhibitor dapagliflozin treatment.Conclusions: These findings indicated that SGLT2 inhibitors can lower serum asprosin levels and improve glucolipid and weight in patients with newly diagnosed T2DM, which may benefit the cardiovascular system.Trial registration: CTR20131268 Registered 20 March 2014 CTR20150102 Registered 03 March 2015 http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml

scholarly journals Effect of sodium-glucose co-transporter-2 inhibitors on the levels of serum asprosin in patients with newly diagnosed type 2 diabetes mellitus

2020 ◽  
Author(s):  
Aijun Jiang ◽  
Zhanrong Feng ◽  
Lu Yuan ◽  
Ying Zhang ◽  
Qian Li ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Body Weight ◽  
Density Lipoprotein ◽  
Sglt2 Inhibitors ◽  
Newly Diagnosed ◽  
Lipid Levels ◽  
Glucose Levels

Abstract BackgroundAsprosin, a novel adipokine which raises glucose levels and stimulates appetite, has been proved to be pathologically increased in populations predisposed to type 2 diabetes mellitus (T2DM), obesity and cardiovascular diseases. The mechanisms of sodium-glucose co-transporter-2 (SGLT2) inhibitors for hypoglycemic effect and cardiovascular protection have not been fully clarified. Therefore, we conducted this study to assess change in the levels of serum asprosin after treatment with SGLT2 inhibitors in patients with newly diagnosed T2DM.MethodsThis study was a randomized, double-blind, placebo-controlled trial. A total of 29 participants with newly diagnosed T2DM with body mass index (BMI) ≥ 23.0 kg/m² and haemoglobin A1c (HbA1c) levels of 58 ~ 85 mmol/mol (7.5%~10%) were randomized to SGLT2 inhibitors dapagliflozin 10 mg/d (n = 19) or placebo (n = 10) treatment for 24 weeks. We analyzed asprosin concentrations by an enzyme-linked immunosorbent assay. In addition, body weight, BMI, HbA1c, fasting plasma glucose (FPG), and lipid levels were measured at baseline and at 24 weeks.ResultsAt 24 weeks, participants with SGLT2 inhibitors treatment exhibited lower the levels of serum asprosin (22.87 vs 45.06 ng/ml in the placebo group; P < 0.001) after adjusting for baseline values. The levels of body weight, BMI, HbA1c, FPG and triglyceride (TG) were decreased, while high density lipoprotein-cholesterol (HDL-C) was increased after SGLT2 inhibitors dapagliflozin treatment compared with placebo (P < 0.05 for all). Low density lipoprotein-cholesterol (LDL-C) and total cholesterol (TC) levels were unchanged in SGLT2 inhibitors group and placebo group. No statistical correlation was found between the levels of serum asprosin and body weight, BMI, HbA1c, FPG, and lipid levels during the SGLT2 inhibitor dapagliflozin treatment.ConclusionsThis study shows that SGLT2 inhibitors can decrease the levels of serum asprosin in patients with newly diagnosed T2DM, which may be involved in SGLT2 inhibitors mechanisms of improving glucose levels and reducing cardiovascular diseases risk factors.Trial registrationISRCTN, ISRCTN2013L01573. Registered 29 august 2013. http://www.icmje.org/search/?q=ISRCTN+2013L01573ISRCTN, ISRCTN2014L00001.Registered 4 January http://www.icmje.org/search/?q=ISRCTN+2014L00001

scholarly journals Anthropometry, Carbohydrate and Lipid Metabolism in the East Flanders Prospective Twin Survey: Linkage of Candidate Genes Using Two Sib-Pair Based Variance Components Analyses

2008 ◽  
Vol 11 (5) ◽  
pp. 505-516 ◽  
Author(s):  
Nicole Y. Souren ◽  
Maurice P. Zeegers ◽  
Rob G. J. H. Janssen ◽  
Anja Steyls ◽  
Marij Gielen ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Birth Weight ◽  
Variance Components ◽  
Single Point ◽  
Hdl Cholesterol ◽  
Suggestive Linkage ◽  
Phenotypic Data ◽  
Linkage Analyses ◽  
Cholesterol Levels

AbstractInsulin resistance and obesity are underlying causes of type 2 diabetes and therefore much interest is focused on the potential genes involved. A series of anthropometric and metabolic characteristic were measured in 240 MZ and 112 DZ twin pairs recruited from the East Flanders Prospective Twin Survey. Microsatellite markers located close to ABCC8, ADIPOQ, GCK, IGF1, IGFBP1, INSR, LEP, LEPR, PPARγ and the RETN gene were genotyped. Univariate single point variance components linkage analyses were performed using two methods: (1) the standard method, only comprising the phenotypic and genotypic data of the DZ twin pairs and (2) the extended method, also incorporating the phenotypic data of the MZ twin pairs. Suggestive linkages (LOD > 1) were observed between the ABCC8 marker and waist-to-hip ratio and HDL-cholesterol levels. Both markers flanking ADIPOQ showed suggestive linkage with triglycerides levels, the upstream marker also with body mass and HDL-cholesterol levels. The IGFBP1 marker showed suggestive linkage with fat mass, fasting insulin and leptin levels and the LEP marker showed suggestive linkage with birth weight. This study suggests that DNA variants in ABCC8, ADIPOQ, IGFBP1 and LEP gene region may predispose to type 2 diabetes. In addition, the two methods used to perform linkage analyses yielded similar results. This was however not the case for birth weight where chorionicity seems to be an important confounder.

scholarly journals The Correlation between Vitamin D and Clinical Implications for Obesity-Related Type 2 Diabetes Mellitus

2020 ◽  
Vol 14 (1) ◽  
pp. 39-45
Author(s):  
Noor Thair Tahir ◽  
Hind SH. Ahmed ◽  
Rasha K. Hashim ◽  
Teba D. Soluiman
Keyword(s):  
Insulin Resistance ◽  
Type 2 Diabetes ◽  
Vitamin D ◽  
Density Lipoprotein ◽  
Obese Group ◽  
Lipoprotein Cholesterol ◽  
Diabetic Patients ◽  
Clinical Implications ◽  
Vitamin D Levels

Background: Obesity and type 2 diabetes have both rapidly raised during the last periods and are ongoing to increase at a disturbing rate universal. Several clinical and epidemiological researches demonstrated a reverse association between circulating vitamin D levels, central adiposity and the progress of insulin resistance and diabetes. Objective: The target of this work was to elucidate the complex role of vitamin D and the clinical implications of diabetes on metabolic defects related with obesity. Subjects and Methods: This study encompassed 90 diabetic patients (45 obese and 45 non obese) who were attending the National Diabetic Center/ Al-Mustansiriyah University during the period from June 2019 to January 2020; their age range was (35-60) years. All participant underwent clinical and biochemical examinations. Results: A substantial rise (p= 0.01) in waist/hip ratio, body mass index, fasting serum glucose, total cholesterol, triacylglycerol, and low density lipoprotein cholesterol in obese diabetic patients as paralleled to non-obese group. Moreover, there was an elevation in glycated hemoglobin, serum insulin, and homeostasis model assessment for insulin resistance in obese group, but it was not significant. A substantial decrease (p= 0.01) in serum high density lipoprotein cholesterol and vitamin D3 were detected in obese diabetic patients as paralleled to non-obese group.       Also, obese diabetic patients had the higher percent (61%) of D3 deficiency as paralleled to non-obese patients. Conclusions: In the present study, it is found that there is significant increase in blood sugar in the individuals with decreased vitamin D levels, which was related with insulin resistance, decreased β-cell function, and obesity.  

scholarly journals Efficacy and Safety of Ertugliflozin in Patients With Type 2 Diabetes Mellitus and Established Cardiovascular Disease Treated With Metformin and Sulfonylurea

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 ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Cardiovascular Disease ◽  
Type 2 Diabetes Mellitus ◽  
Body Weight ◽  
Glycemic Control ◽  
Sglt2 Inhibitor ◽  
Efficacy And Safety

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 &lt;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&lt;0.001). A higher proportion of patients in each ERTU group achieved HbA1c &lt;7% relative to placebo (P&lt;0.001). ERTU significantly reduced FPG and body weight (P&lt;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.

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