Significant Reduction In Fasting Plasma Glucose Research Articles

Evaluating the impact of efpeglenatide on cardiometabolic and safety outcomes in individuals with diabetes: a systematic review and meta-analysis.

Efpeglenatide, a novel GLP-1 receptor agonist, has shown promise in improving glycemic control and inducing weight loss in individuals with type 2 diabetes (T2DM). This meta-analysis assessed its therapeutic potential and safety profile. A literature search was conducted on PubMed, SCOPUS, and Cochrane Central from inception until September 2023. We selected patients with T2DM and identified and compared those receiving efpeglenatide to placebo. Outcomes assessed included fasting plasma glucose (FPG), HbA1c, body weight, BMI, and cardiometabolic parameters. Data were analyzed using a random-effects model, with results presented as mean differences (MD) for continuous outcomes and risk ratios (RR) for safety analysis, along with their respective 95% confidence intervals. Quality assessment was conducted using the Cochrane risk of bias tool. We included 11 studies in our analysis. Efpeglenatide demonstrated significant reductions in FPG (MD = -1.53 mmol/L, 95% CI = [-2.86, -0.66], p < 0.01), HbA1c (MD = -0.84, 95% CI= [-1.08, -0.60], p < 0.01), body weight (MD = -2.24kg, 95% CI = [-4.20, -2.00], p < 0.01), and BMI (MD = -1.61kg/m2, 95% CI= [-2.12, -1.09], p < 0.01). However, efpeglenatide was associated with a moderate increase in the risk of gastrointestinal adverse events, nausea, diarrhea, and vomiting. There was a non-significant elevated risk of hypoglycemia. Efpeglenatide significantly improves glycemic outcomes and promotes weight loss in individuals with diabetes. However, it is associated with moderate adverse effects related to the gastrointestinal system. Thus, further trials are warranted to comprehensively assess its safety and efficacy to derive a robust conclusion. The online version contains supplementary material available at 10.1007/s40200-024-01409-3.

Effect of Zuo's warming Yang acupuncture therapy combined with lifestyle interventions on prediabetes: A randomized controlled trial

BackgroundAcupuncture has promising effects on diabetes, but there is limited evidence on prediabetes. The purpose of this study was to evaluate the effect and safety of Zuo's warming Yang acupuncture therapy on prediabetic patients. MethodsFifty five individuals with prediabetes were recruited for the study. Participants in the non-acupuncture group received a 12-week lifestyle intervention, while those in the acupuncture group received the same lifestyle intervention in addition to two 50-minute sessions of Zuo's warming Yang acupuncture therapy per week. The primary outcomes measure fasting plasma glucose (FPG), 2-hour postprandial glucose (2hPG), and Glycated hemoglobin determination (HbA1c) after 12 weeks of treatment. ResultsBoth acupuncture group and non-acupuncture group showed significant reductions in FPG and 2hPG levels after treatment, with a statistically significant difference between them (FPG:6.25 ± 0.48 vs 5.73 ± 0.50, P < 0.001; 6.21 ± 0.42 vs 6.04 ± 0.41, P = 0.035; 2hPG:8.90(8.44,9.88) vs 7.95(6.93,8.34), P < 0.001; 9.22 ± 1.15 vs 8.70 ± 1.34, P = 0.046; respectively). In addition, FPG and 2hPG in the acupuncture group decreased more significantly than those in the non-acupuncture group after treatment, and the difference was statistically significant (FPG:5.73 ± 0.50 vs 6.04 ± 0.41, P = 0.014;2hPG:7.95(6.93,8.34) vs 8.70 ± 1.34, P = 0.015; respectively). Although both groups showed reductions in HbA1c, only the decrease in the acupuncture group was statistically significant(5.80(5.60,5.90) vs 5.60(5.40,5.80), P = 0.015). No severe adverse events were reported. ConclusionsZuo's warming Yang acupuncture therapy conjunction with lifestyle interventions was more effective than lifestyle interventions alone in reducing FPG, 2hPG and HbA1c levels in prediabetic patients. These results suggest that Zuo's warming Yang acupuncture therapy may be a safe and effective treatment option for prediabetes.

Anti-hyperglycemic effects of propolis or metformin in type 2 Diabetes Mellitus.

Background: The aim of this study was to evaluate the effect of propolis or metformin versus placebo on glycemic control in pharmacological treatment-naïve patients with type 2 diabetes mellitus (T2DM). Methods: A double-blind, randomized, placebo-controlled in parallel groups clinical trial was performed in 36 pharmacological treatment-naïve patients with T2DM. They received propolis (300 mg), metformin (850 mg), or placebo twice daily before breakfast and dinner for 12 weeks. At the beginning and end of the study, fasting plasma glucose (FPG), 2-h postload glucose (2-h PG) during a 75-g oral glucose tolerance test, glycated hemoglobin A1c (A1C) and a metabolic profile were measured. Areas under the curve (AUC) of glucose and insulin, total insulin secretion (insulinogenic index), the first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index) were calculated. Statistical analyses: Kruskal-Wallis, Mann-Whitney U and Wilcoxon tests. Results: The propolis and metformin groups exhibited significant reductions in FPG (p=0.009 and p=0.001, respectively), 2-h PG (p=0.034 and p=0.001, respectively) levels, AUC of insulin, Stumvoll index, and an increment in the Matsuda index. The comparison of the changes from baseline to the end showed significant differences between placebo and propolis in FPG (p=0.004) and A1C (p=0.049) levels, while between placebo and metformin were in FPG (p=0.002), 2-h PG (p=0.004) and A1C (p=0.007) levels. Conclusions: The administration of propolis and metformin compared to placebo reduced FPG and A1C levels; in addition, metformin decreased 2-h PG, AUC of glucose and insulin, high-density lipoprotein cholesterol, and increased the insulin sensitivity.

IDF21-0679 INTENSIFY: effectiveness of insulin degludec/liraglutide (IDegLira) in a real-world T2DM population in the UAE

Background: In patients with type 2 diabetes mellitus (T2DM) and inadequate glycaemic control, combining a glucagon-like peptide-1 receptor agonist (GLP-1 RA) with basal insulin (BI) offers an effective treatment-intensification strategy. A fixed-ratio combination of insulin degludec and liraglutide (IDegLira; Novo Nordisk) was launched in the United Arab Emirates (UAE) in 2018. Aim: To investigate the effect of IDegLira in a real-world population of patients with T2DM switching from BI or GLP-1 RA (± oral antidiabetic drugs [OADs]) in routine clinical practice in the UAE. Method: INTENSIFY was a 26–38-week, multicentre, prospective, non-interventional, real-world study. T2DM patients (≥18 years) with inadequate glycaemic control on BI or GLP-1 RA (± OADs) were eligible if a switch to IDegLira had been planned. The primary endpoint was change in laboratory measured HbA1c from baseline to end of the study. Secondary endpoints included overall change in fasting plasma glucose (FPG); change in body weight; incidence of hypoglycaemic episodes in the 4-week (non-severe and nocturnal non-severe episodes) and 26-week (severe episodes) periods before end of study (EOS) versus before initiation of IDegLira treatment. Treatment preference and safety were also assessed. ClinicalTrials.gov identifier: NCT03823339 Results: Among 263 patients, 206 (78.3%) and 57 (21.7%) patients had previously received BI ± OADs and GLP-1 RA ± OADs, respectively. Baseline mean HbA1c was 9.29%. Switching to IDegLira was associated with a significant overall reduction in HbA1c, with an estimated mean (SE) change from baseline of –0.9% (0.1%), 95% CI, –1.1 to –0.7 (p<0.0001). There was also a significant reduction in FPG: overall mean (SE) change from baseline was –48.2 (5.9) mg/dL, 95% CI, –59.9 to –36.5 (p<0.0001). A significant reduction in body weight was achieved among patients previously treated with BI ± OADs,with an estimated mean (SE) change from baseline of –1.1 (0.2) kg, 95% CI, –1.5 to –0.6 (p<0.0001). The estimated incidence of hypoglycaemic episodes was numerically lower in the periods before EOS versus before initiation of IDegLira treatment (2 vs. 13, 2 vs. 6, and 2 vs. 4 episodes for non-severe, nocturnal non-severe, and severe hypoglycaemia, respectively). Overall, the number of IDegLira dose steps increased significantly (mean [SE] change, 6.1 [0.6] steps, 95% CI, 5.0–7.2 [p<0.0001]). Most patients (86%) preferred IDegLira over previous treatments. IDegLira was well tolerated with no unexpected safety findings. Discussion: Switching from BI or GLP-1 RA (± OADs) to IDegLira significantly improved glycaemic control in adults with T2DM. There were significant overall reductions in HbA1c and FPG; a significant reduction in body weight among patients previously on BI ± OADs, and a reduction in hypoglycaemic events. Conservative dose titration (an increase of approximately 1 dose step per month) was identified in the INTENSIFY study. A stricter titration schedule and frequent interaction between patients and investigators may have led to greater improvement in both primary and secondary endpoints.

Effect of Dapagliflozin in Combination with Lobeglitazone and Metformin in Korean Patients with Type 2 Diabetes in Real-World Clinical Practice.

PurposeThis study aimed to evaluate the efficacy and tolerability of dapagliflozin as an add-on or a switch therapy to lobeglitazone plus metformin (MFM) in Korean patients with inadequately controlled type 2 diabetes mellitus (T2DM) in real-world clinical practice.Materials and MethodsThe study included 109 patients who started dapagliflozin as add-on or switch therapy to lobeglitazone plus MFM. The primary outcome was a change in glycated hemoglobin (HbA1c) level from baseline after 12 months of treatment. Secondary outcomes included changes in fasting plasma glucose (FPG), lipid profiles, body weight, visceral fat area (VFA), and blood pressure after 12 months of treatment.ResultsThe baseline HbA1c was 8.3±1.3% (8.7±1.5% in the add-on group and 8.1±1.0% in the switch group). After 12 months, mean HbA1c decreased (-0.91%) in all patients (p<0.05) (-1.39% in the add-on group and -0.63% in the switch group). Significant reductions in FPG were also observed in both the add-on and switch groups (-54.37 mg/dL and -24.68 mg/dL, respectively). Overall, there was a significant improvement in serum triglyceride (-24.74 mg/dL), low density lipoprotein cholesterol (-7.92 mg/dL), body weight (-2.98 kg), VFA (-9.00 cm2), and systolic blood pressure (-8.67 mm Hg). Approximately 35.8% of patients achieved HbA1c <7.0% after 12 months.ConclusionDapagliflozin, as an add-on or a switch therapy to lobeglitazone plus MFM, can be a suitable alternative for Korean patients with inadequately controlled T2DM. The combination therapy resulted in significant reductions in HbA1c levels, body weight, and blood pressure.

Nutritional Intervention Reduces Dyslipidemia, Fasting Glucose and Blood Pressure in People Living with HIV/AIDS in Antiretroviral Therapy: A Randomized Clinical Trial Comparing Two Nutritional Interventions.

Antiretroviral therapy (ART) increases the risk of cardiometabolic diseases in people living with HIV/AIDS (PLWHA). However, there is a lack of evidence regarding the effectiveness of a nutritional intervention on several cardiometabolic parameters in this population. Therefore, this study aimed to evaluate the effectiveness of two nutritional interventions on several cardiometabolic parameters in PLWHA treated with ART. A parallel randomized clinical trial was performed with PLWHA treated with ART. The participants (n = 88) were divided into two intervention groups: (1) nutritional counseling (n = 44) and (2) individualized dietary prescription (n = 44). The follow-up period was 30 weeks. A reduction in low-density lipoprotein (LDL) was the primary outcome. Secondary outcome variables were reductions in total cholesterol (TC), triglycerides (TG), fasting plasma glucose (FPG), systolic and diastolic blood pressures (SBP and DBP, respectively), waist circumference (WC), body mass index (BMI), and increases in high-density lipoproteins (HDL). A multiple linear regression was used to analyze the effectiveness of the interventions, adjusted for sociodemographic, lifestyle, and clinical characteristics. Sixty-two PLWHA completed the trial (nutritional counseling, n = 32; individualized dietary prescription, n = 30). At follow-up, we observed in the nutritional counseling group significant reductions in SBP (p = 0.036) and DBP (p = 0.001). Significant reductions in FPG (p = 0.008) and DBP (p = 0.023) were found in the individualized dietary prescription group. In the fully adjusted models, significant reductions in LDL, SBP, DBP, and BMI were found in the individualized dietary prescription group. In conclusion, the two investigated nutritional interventions were effective in reducing some cardiometabolic risk factors in PLWHA. However, after adjustments for covariates, the individualized dietary prescription showed significant reductions in the primary outcome and, also, in more cardiometabolic risk factors than the nutritional counseling.

The antidiabetic and antilipidemic effects of Hibiscus sabdariffa: A systematic review and meta-analysis of randomized clinical trials.

Hibiscus sabdariffa (HS) is a woody-based subshrub of the Malvaceae family which has various uses in traditional medicine. This review systematically evaluates the evidence from clinical trials on the antidiabetic activity of HS. A random-effects model was used to obtain summary estimates. Five outcome measure, including fasting plasma glucose (FPG), total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoproteins (LDL), and triglyceride (TG) were assessed in the study. The results of the overall pooled statics for the FPG level showed that there was a significant reduction in FPG (WMD=-3.964mg/dL; 95% CI: -6.227 to -1.702 and P-value was 0.001) and in the level of LDL (WMD=-7.843mg/dL; 95% CI: -14.337 to -1.350 and P-value was 0.018). However, the pooled estimate showed that there was no statistically significant change on the TC (WMD=-30.382mg/dL; 95% CI: -66.752 to 5.989 and P value was 0.102), the HDL (WMD=0.074mg/dL; 95% CI: -1.986 to 2.135 and P value was 0.944) and the TG (WMD=-9.050mg/dL; 95% CI, -30.819 to 12.719 and P value was 0.102) compared to the placebo. Egger's weighted regression P values suggested that there was no potential publication bias in the FPG (P=0.664), HDL (P=0.065), LDL (P=0.677) and TG (P=0.232) but there was a publication bias in the TC (0.056). Therefore, the result of this meta-analysis clearly shows that HS has antidiabetic activity, whereas its lipid-lowering effect needs further study.

Efficacy and Safety of Sodium-Glucose Cotransporter-2 Inhibitors in Korean Patients with Type 2 Diabetes Mellitus in Real-World Clinical Practice

BackgroundThis study aimed to evaluate the efficacy and safety of sodium-glucose cotransporter-2 (SGLT2) inhibitors in Korean patients who had inadequately controlled type 2 diabetes mellitus (T2DM) in real-world clinical practice.MethodsWe included 410 patients who started SGLT2 inhibitors (empagliflozin or dapagliflozin) as add-on therapy or switch therapy between February 2015 and June 2017. The primary efficacy endpoint was a change in glycosylated hemoglobin (HbA1c) from baseline to week 12. The secondary endpoints were patients achieving HbA1c <7.0% and changes in the fasting plasma glucose (FPG), lipid profiles, body weight, and blood pressure (BP).ResultsThe mean HbA1c at baseline was 8.5% (8.6% in the add-on group and 8.4% in the switch group). At week 12, the mean adjusted HbA1c decreased by −0.68% in the overall patients (P<0.001), by −0.94% in the add-on group, and by −0.42% in the switch group. Significant reductions in FPG were also observed both in the add-on group and switch group (−30.3 and −19.8 mg/dL, respectively). Serum triglyceride (−16.5 mg/dL), body weight (−2.1 kg), systolic BP (−4.7 mm Hg), and diastolic BP (−1.3 mm Hg) were significantly improved in the overall patients. Approximately 18.3% of the patients achieved HbA1c <7.0% at week 12. A low incidence of hypoglycemia and genital tract infection was observed (6.3% and 2.2%, respectively).ConclusionSGLT2 inhibitors can be a suitable option as either add-on or switch therapy for Korean patients with inadequately controlled T2DM.

Effect of Ramadan fasting on glycaemic parameters & body mass index in type II diabetic patients: A meta-analysis.

Background & objectives:There has been an ongoing debate about the impact of Ramadan fasting (RF) on the health of these individuals who fast during Ramadan. The aim of this meta-analysis was to evaluate the relationship between RF and glycaemic parameters in type 2 diabetes mellitus (T2DM) patients.Methods:Search terms were decided and databases such as MEDLINE EBSCO, Google Scholar and EMBASE were searched for eligible studies. Standardized mean differences and 95 per cent confidence intervals (CIs) of post-prandial plasma glucose (PPG), fasting plasma glucose (FPG), glycated haemoglobin (HbA1c) (%) and fructosamine levels were calculated for different treatment regimens.Results:Of the 40 studies, 19 were found eligible for inclusion in the meta-analysis. Based on pooled results, significant reductions in FPG were found in single oral antidiabetics (OAD) [standardized weighted mean difference (SMD)=0.47, 95% CI=(0.20-0.74)], multi-OAD [SMD=0.36, 95% CI=(0.11-0.61)] and multitreatment subgroups [SMD=0.65, 95% CI=(0.03-1.27)] and overall [SMD=0.48, 95% CI=(0.27-0.70)]. Furthermore, HbA1c (%) [SMD=0.26, 95% CI=(0.03-0.49)] and body mass index (BMI) [SMD=0.18, 95% CI=(0.04-0.31)] were significantly decreased in the multi-OAD group.Interpretation & conclusions:The meta-analysis showed that RF was not associated with any significant negative effects on PPG and fructosamine levels. However, BMI and FPG and HbA1c (%) were positively affected by RF.

The effects of probiotics and synbiotic supplementation on glucose and insulin metabolism in adults with prediabetes: a double-blind randomized clinical trial.

Probiotics and/or prebiotics could be a promising approach to improve metabolic disorders by favorably modifying the gut microbial composition. To assess the effects of probiotics and synbiotic on glycemic indices in prediabetic individuals who are at risk of type 2 diabetes and its complications. In a double-blind, randomized, placebo-controlled parallel-group clinical trial, 120 prediabetic adults participated and were randomly allocated to receive either probiotics or synbiotic or placebo supplements for 24weeks. Anthropometric measurements, food record, physical activity and glycemic biomarkers including glycated hemoglobin (HbA1C), fasting plasma glucose (FPG), fasting insulin levels (FIL), homoeostasis model assessment for insulin resistance (HOMA-IR), quantitative insulin sensitivity check index (QUICKI), and β-cell function (HOMA-B) were assessed at baseline and repeated at 12 and 24weeks and compared within and between three groups using repeated measure ANOVA. Compared with the placebo, synbiotic supplementation resulted in a higher significant reduction in FPG (- 6.5 ± 1.6 vs. - 0.82 ± 1.7mg/dL, P = 0.01), FIL (- 2.6 ± 0.9 vs. - 0.8 ± 0.8 µIU/mL, P = 0.028), and HOMA-IR (- 0.86 ± 0.3 vs. - 0.16 ± 0.25, P = 0.007), and a significant elevation in the QUICKI (+ 0.01 ± 0.003 vs. + 0.003 ± 0.002, P = 0.006). In addition, significant decreases in HbA1C was seen following the supplementation of probiotics and synbiotic compared with the placebo (- 0.12 ± 0.06 and - 0.14 ± 0.05 vs. +0.07 ± 0.06%, P = 0.005 and 0.008, respectively). HOMA-B was not found to be different between or within the three groups. Glycemic improvement by probiotics and particularly synbiotic supplements in prediabetic individuals has been supported by current study. However, further studies are required for optimal recommendations in this important area of patient treatment. Iranian Registry of Clinical Trials: IRCT201511032321N2, Date registered February 27, 2016.

Influence of Time of Yoga Practice and Gender Differences on Blood Glucose Levels in Type 2 Diabetes Mellitus and Normal Healthy Adults

Prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Many studies have demonstrated the effectiveness of yoga in improving glycaemic control, whereas no studies are available showing the impact of time of practice on glucose levels. The current study explores the effect of time of yoga practice on glucose levels in community-dwelling adults with and without T2DM. A total of 189 subjects with T2DM and 121 subjects without T2DM underwent a 10-day yoga program which includes practical and theory lecture sessions for 60min every day, either in the morning or evening. Baseline and post-intervention assessments of fasting plasma glucose (FPG) were measured on day-1 and day-10, respectively. Data analysis were done using Statistical Package for the Social Sciences (SPSS), version 16. Results of the study showed that in individuals with T2DM, a significantly higher reduction in FPG was observed while practicing yoga in the evening sessions than in the morning sessions. Likewise, a significant reduction in FPG was observed only in women who practiced yoga in the evening than in the morning, in non-diabetic healthy individuals, while the reduction was not statistically significant in men. Results of this study suggest that reduction in FPG level was better while practicing yoga in evening than morning. Similarly, women had a better reduction in blood glucose level than men.

Fasting plasma glucose and lipid profiles of diabetic patients improve with aerobic exercise training.

This study presents the effects of aerobic exercise training on fasting plasma glucose and lipid profiles (FPG/LP) of diabetic patients in Kumasi. A randomised experimental with control design. The study was conducted at the diabetic unit of KATH in Kumasi, Ghana. Twelve diabetic patients [grouped into intervention (IG) and control (CG)] attending the diabetic unit of KATH with diabetes diagnosis durations less than fifty years, ambulant status/age of 20-68years, sedentary and free from complications. Eight weeks aerobic exercise training between August 2015 and March 2016. Body weight (BW), Body mass index (BMI), fasting plasma glucose (FPG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (T) and total cholesterol (TC). Body weight (4.85kg, 7.0%), body mass index (4.08kg/m2, 7.3%), FPG (5.28mmol/L, 43.5%), LDL-C (.33mmol/l, 11.9%), TC (.47 mmol/l, 5.3%) and T (.48mmol/l, 29.4%) profiles of the patients in IG declined while HDL-C (.11mmol/l, 7.1%) increased. IG patients improved significantly in FPG [6.27 ± 0.91 < 8.00 ± 0.96; t=-52.00, P = 0.000], BW [58.60 ± 15.34 < 75.35 ± 22.00; t= 3.29, P = 0.040] and BMI [23.45 ±5.03<27.04 ±4.78, t=4.24, P = .050] compared to CG. Patients in IG, in addition to conventional care, experienced non-significant decline in LDL-C, TC, T, increase in HDL-C and significant reduction in FPG, BW, and BMI over those receiving conventional care only. Exercise Scientists are recommended to handle exercise sessions for healthcare prevention and management routines of diabetic patients. Not declared.

A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes.

AimsTo assess the safety and efficacy of omarigliptin in Japanese patients with type 2 diabetes (T2D).MethodsIn a 24‐week double‐blind trial, 414 patients with T2D were randomized to omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo. The double‐blind period was followed by a 28‐week open‐label extension during which all patients received omarigliptin 25 mg once weekly. Efficacy endpoints were glycated haemoglobin (HbA1c), 2‐hour postprandial glucose (PPG) and fasting plasma glucose (FPG) levels.ResultsAfter 24 weeks, the least squares (LS) mean change from baseline in HbA1c was −0.66% for omarigliptin, −0.65% for sitagliptin and 0.13% for placebo. The difference in LS mean for omarigliptin vs placebo was −0.80% (P < .001). The difference in LS mean for omarigliptin vs sitagliptin was −0.02% (95% confidence interval −0.15, 0.12), which met the criterion for non‐inferiority to sitagliptin. Both active treatments provided significant reductions in FPG and 2‐hour PPG compared with placebo (P < .001). Over the 24‐week double‐blind period, there were no clinically meaningful differences in the incidence rates of adverse events among the treatment groups. There was 1 episode of symptomatic hypoglycaemia in the sitagliptin group and none in the omarigliptin or placebo groups. In the 28‐week open‐label period, omarigliptin provided persistent improvements in glycaemic control without notable change in safety profile compared with the double‐blind period. Omarigliptin had no meaningful effect on body weight.ConclusionsIn Japanese patients with T2D, omarigliptin 25 mg once weekly provided significant glucose‐lowering compared with placebo and was non‐inferior to sitagliptin 50 mg once daily. Omarigliptin was generally well tolerated for up to 52 weeks.

A randomized comparative study of efficacy and safety of saroglitazar with fenofibrate in diabetic dyslipidemic patients on metformin and glimeperide

Background: This study was conducted to compare the efficacy and safety of saroglitazar with fenofibrate in Indian diabetic dyslipidemic patients who were on Metformin and Glimepiride.Methods: Adults patients with diabetic dyslipidaemia fulfilling the inclusion criteria were randomized in two groups. Group A patients received metformin (1000 mg/ day) + Glimepiride (4 mg/day) with fenofibrate (160 mg/day), while group B patients received metformin (1000 mg/day) + Glimepiride (4 mg/day) with saroglitazar (4 mg/day). Glycosylated haemoglobin (HbA1C), triglyceride (TG), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C) levels were measured at baseline and at 12 weeks. Fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG) were measured at baseline and at 4, 8 and 12 weeks.Results: There was a significant reduction in TG and HbA1C levels at 12 weeks from the baseline value (p=0.001) in both groups. However, there was no significant reduction in TG between the groups at 12 weeks but HbA1C levels in group B decreased significantly compared to group A at 12 weeks. Also, there was a significant reduction in FPG and PPPG levels at 4, 8 and 12 weeks in both groups from their baseline values (p=0.001). The reduction in FPG and PPPG levels in group B was statistically significantly compared to group A at every interval. There was statistically significant change in LDL-C and HDL-C at 12 weeks from baseline in both the groups. Also, there was significant rise in HDL-C in group B when compared to group A.Conclusions: Group B patients on saroglitazar with metformin and Glimepiride showed a significant reduction in HbA1C, FPG and PPG levels compared to group A patients on fenofibrate with metformin and Glimepiride.

Effect of lifestyle interventions on glucose regulation among adults without impaired glucose tolerance or diabetes: A systematic review and meta-analysis.

This study systematically assessed the effectiveness of lifestyle interventions on glycemic indicators among adults (⩾18years) without IGT or diabetes. Randomized controlled trials using physical activity (PA), diet (D), or their combined strategies (PA+D) with follow-up ⩾12months were systematically searched from multiple electronic-databases between inception and May 4, 2016. Outcome measures included fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), fasting insulin (FI), homeostasis model assessment-estimated insulin resistance (HOMA-IR), and bodyweight. Included studies were divided into low-range (FPG <5.5mmol/L or HbA1c <5.5%) and high-range (FPG ⩾5.5mmol/L or HbA1c ⩾5.5%) groups according to baseline glycemic levels. Seventy-nine studies met inclusion criteria. Random-effect models demonstrated that compared with usual care, lifestyle interventions achieved significant reductions in FPG (-0.14mmol/L [95%CI, -0.19, -0.10]), HbA1c (-0.06% [-0.09, -0.03]), FI (%change: -15.18% [-20.01, -10.35]), HOMA-IR (%change: -22.82% [-29.14, -16.51]), and bodyweight (%change: -3.99% [-4.69, -3.29]). The same effect sizes in FPG reduction (0.07) appeared among both low-range and high-range groups. Similar effects were observed among all groups regardless of lengths of follow-up. D and PA+D interventions had larger effects on glucose reduction than PA alone. Lifestyle interventions significantly improved FPG, HbA1c, FI, HOMA-IR, and bodyweight among adults without IGT or diabetes, and might reduce progression of hyperglycemia to type 2 diabetes mellitus.

Efficacy and safety of titrated canagliflozin in patients with type 2 diabetes mellitus inadequately controlled on metformin and sitagliptin.

AimsTo evaluate the efficacy and safety of titrated canagliflozin, a sodium glucose co‐transporter 2 inhibitor, in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and sitagliptin.MethodsIn this randomized, double‐blind study, patients with T2DM (N = 218) on metformin ≥1500 mg/day and sitagliptin 100 mg received canagliflozin 100 mg or placebo. After 6 weeks, the canagliflozin dose was increased from 100 to 300 mg (or from placebo to matching placebo) if all of the following criteria were met: baseline estimated glomerular filtration rate ≥70 ml/min/1.73 m2; fasting self‐monitored blood glucose ≥5.6 mmol/l (≥100 mg/dl); and no volume depletion–related adverse events (AEs) within 2 weeks before dose increase. Endpoints included change in glycated haemoglobin (HbA1c) at week 26 (primary); proportion of patients achieving HbA1c <7.0%; and changes in fasting plasma glucose (FPG), body weight and systolic blood pressure (SBP). Safety was assessed using AE reports.ResultsOverall, 85.4% of patients were titrated to canagliflozin 300 mg or matching placebo (mean ± standard deviation time to titration 6.2 ± 0.8 weeks). At week 26, canagliflozin (pooled 100 and 300 mg) demonstrated superiority in HbA1c reduction versus placebo (−0.91% vs. −0.01%; p < 0.001). Canagliflozin provided significant reductions in FPG, body weight and SBP compared with placebo (p < 0.001). The overall AE incidence was 39.8 and 44.4% for canagliflozin and placebo, respectively. Canagliflozin was associated with an increased incidence of genital mycotic infections.ConclusionsTitrated canagliflozin significantly improved HbA1c, FPG, body weight and SBP, and was generally well tolerated over 26 weeks in patients with T2DM as add‐on to metformin and sitagliptin.

Effects of Hormone Replacement Therapy on Insulin Resistance in Postmenopausal Diabetic Women.

BACKGROUND:Insulin resistance (IR) is closely associated with diabetes mellitus. On the other hand, increased visceral fat in menopause is also associated with IR, which makes postmenopausal diabetic women in a big risk for cardiovascular diseases. There are conflicting reports about the effects on hormone replacement therapy (HRT) on IR.AIM:The aim of the study was to investigate the effects of HRT on IR.METHODS:A total of 40 postmenopausal women with type 2 diabetes were enrolled and followed for 12 months. Half of them were assigned to take HRT, while the other half made the control group. Fasting plasma glucose (FPG) and insulinemia were measured in both groups at baseline and after 12 months. IR was represented by Homeostatic model assessment for IR (HOMA-IR).RESULTS:HRT was associated with significant decrease in HOMA-IR, FPG and insulinemia in the examined group. There was no significant reduction in FPG and no significant increase in insulinemia levels and HOMA-IR values in control group after 12 months.CONCLUSION:HRT was associated with statistically signifficant increase of insulin sensitivity. Larger clinical trials will be necessary to understand whether HRT may improve insulin resistance and glucose homeostasis in women with diabetes, especially when given shortly after entering menopause.

Efficacy and safety of luseogliflozin as monotherapy in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled, phase 3 study

Objective:Luseogliflozin – a novel, orally bioavailable, 1-thio-d-glucitol derivative and a selective sodium glucose cotransporter 2 inhibitor – has shown efficacy and tolerability in previous phase 2 studies. This phase 3, randomized, double-blind, placebo-controlled, comparative study aimed to confirm the superiority of 24 week luseogliflozin 2.5 mg monotherapy over placebo in reducing hemoglobin A1c (HbA1c) levels in Japanese patients with type 2 diabetes mellitus (T2DM).Methods:Patients with HbA1c levels of 6.9%–10.5% were randomized to receive luseogliflozin 2.5 mg or placebo once daily for 24 weeks (n = 79 in each group). The primary endpoint was change from baseline in HbA1c at end of treatment. Secondary endpoints included change from baseline in fasting plasma glucose (FPG) and postprandial plasma glucose (PPG) following a meal tolerance test, body weight, and abdominal circumference. Safety assessments included adverse events (AEs), clinical laboratory tests, and vital signs.Results:At the end of treatment, HbA1c was significantly decreased from baseline in the luseogliflozin 2.5 mg group (−0.63%) versus the placebo group (0.13%), with a between-group difference of −0.75% (p < 0.001). Additionally, significant reductions in FPG, PPG, body weight, and abdominal circumference were noted with luseogliflozin compared with placebo (all p < 0.05). Luseogliflozin was well tolerated; there was no significant difference between groups in the incidence of AEs (luseogliflozin, 59.5%; placebo, 57.0%). No AEs led to study drug discontinuation. Most AEs were mild in severity, with no severe AE reported. Limitations of this study include its short study duration and small sample size.Conclusion:Luseogliflozin monotherapy for 24 weeks was superior to placebo in reducing HbA1c levels. It also reduced FPG, PPG, body weight, and abdominal circumference and was well tolerated in Japanese patients with T2DM.Clinical trial registration:JapicCTI-111661.

Effects of NOS1AP rs12742393 Polymorphism on Repaglinide Response in Chinese Patients with Type 2 Diabetes Mellitus

To investigate the associations of NOS1AP rs12742393 polymorphism with the risk of type 2 diabetes mellitus (T2DM) and repaglinide therapeutic efficacy in Chinese patients with T2DM. Prospective case-control study. Academic medical center. A total of 300 patients with T2DM and 200 healthy volunteers were enrolled to identify NOS1AP rs12742393 genotypes using the polymerase chain reaction-restriction fragment length polymorphism assay. Eighty-four patients with various genotypes were randomly selected to receive oral repaglinide as a single-agent therapy (3mg/day) for 8weeks. Anthropometric measurements and fasting plasma glucose (FPG), postprandial plasma glucose, hemoglobin A1c , fasting serum insulin (FINS), postprandial serum insulin, homeostasis model assessment for insulin resistance (HOMA-IR), triglyceride, total cholesterol, low-density lipoprotein-cholesterol, and high-density lipoprotein-cholesterol tests were obtained before and after repaglinide treatment. The risk C allelic frequency of NOS1AP rs12742393 was higher in patients with T2DM than in healthy volunteers (p<0.001). Patients with T2DM and genotypes AA and AC at NOS1AP rs12742393 had a significant reduction in FPG (mmol/l) compared with those with genotype CC (p<0.01). Patients with CC homozygotes and AC heterozygotes had a greater increase in FINS (mU/l) than those with wild-type AA (p<0.05). In addition, the carriers of genotype CC at NOS1AP rs12742393 had higher differential values of HOMA-IR compared with genotypes AC and AA carriers (p<0.001). The effects of repaglinide treatment on FPG (p<0.01), FINS (p<0.05) and HOMA-IR (p<0.001) were reduced in patients with T2DM carrying the NOS1AP rs12742393 risk C allele compared with the AA genotype carriers. The NOS1AP rs12742393 polymorphism is associated with therapeutic efficacy of repaglinide in Chinese T2DM patients.

Insulin degludec as an ultralong-acting basal insulin once a day: a systematic review.

BackgroundInsulin degludec (IDeg) is a neutral, ultralong-acting new generation basal insulin analog developed by NovoNordisk currently in Phase III clinical development. IDeg offers a duration of action of more than 42 hours in adults, much longer than current basal insulin formulations.ObjectiveThe aim of this review is to assess the efficacy and safety data of IDeg in the treatment of type 1 and type 2 diabetes mellitus.MethodsRelevant English language articles from 2010 to 2012 were identified through MEDLINE, PubMed, EMBASE, Scopus, BIOSIS, and Google Scholar. Online conference proceedings of the 71st ADA Scientific Sessions and the 47th EASD Annual Meeting were reviewed. Studies were compared in terms of their study designs, primary and secondary efficacy parameters, and tolerability data.ResultsThere are a total of nine published trials investigating the clinical efficacy and safety of IDeg in over 3000 subjects with type 1 and 2 diabetes. Only three trials were published in full. All were open-label, randomized multicenter trials with durations of 16 to 52 weeks. IDeg and coformulations of IDeg with insulin aspart (IAsp) were compared to insulin glargine (IGlar), detemir, and biphasic IAsp 30 (BIAsp 30).ConclusionBased upon the available evidence, there appear to be no reported differences between IDeg and IGlar, detemir, or BIAsp 30 in the reduction of the primary efficacy end-points of HbA1c and mean fasting plasma glucose (FPG) concentrations. Only flexible dosing of IDeg provided a significant reduction in FPG compared to IGlar. IDeg demonstrated a significant reduction in nocturnal hypoglycemia in type 1 diabetes. In type 2 diabetes, IDeg reduced the incidence of hypoglycemia by 18% and 58% compared to IGlar and BIAsp 30, respectively.