Mean Postprandial Plasma Glucose Research Articles

Real-world Retrospective Assessment of Initiation and Effectiveness of Dual Combination Therapy with Metformin and Teneligliptin in Drug Naïve Indian Type 2 Diabetes Mellitus Patients (INITIATE)

Introduction: Diabetes Mellitus (DM) has become the leading health concern worldwide over the last few decades. But despite advances in both understanding of the pathophysiology of Type 2 Diabetes Mellitus (T2DM), and the development of new treatment strategies, current management of patients with T2DM remains suboptimal. Initial monotherapy is frequently inadequate in patients with high baseline Glycated Haemoglobin (HbA1c). Thus, initial combination therapy has emerged as an alternative approach. Aim: To assess INItiation and effecTiveness of dual combInation therapy with metformin And Teneligliptin in drug naïvE T2DM patients (INITIATE). Materials and Methods: In this retrospective, multicentre study, newly diagnosed drug naïve T2DM patients failed with diet and exercise prior to screening and initiated with dual therapy of metformin and teneligliptin were enrolled. Data of all the patients prescribed with any therapeutic dose of metformin (250 mg, 500 mg, 750 mg, 1000 mg, 1500 mg, 2000 mg) and teneligliptin (20 mg, 40 mg) was considered. The data was analysed to assess change in glycaemic parameters from baseline to 12 weeks. Paired t-test was applied for statistical results. Results: Data of 7857 patients were analysed. The mean change of Fasting Plasma Glucose (FPG) from baseline {202.29±52.2 mg/dL (11.23±2.89 mmol/L)} to 12 weeks {142.57±34.5 mg/dL (7.91±1.91 mmol/L)} was -59.72±17.7 mg/dL (-3.31±0.98 mmol/L) (p-value <0.0001). The absolute change in mean Postprandial Plasma Glucose (PPG) from baseline {(286.26±80.43 mg/dL (15.89±4.46 mmol/L)} to 12 weeks {(198.30±42.24 mg/dL (11±2.34 mmol/L)} was -87.96±38.19 mg/dL (-4.88±2.12 mmol/L) (p-value <0.0001). Mean HbA1c level was 8.11%±1% (65±10.9 mmol/mol) at baseline and decreased significantly to 7.15%±0.94% (55±10.3 mmol/mol) (p-value <0.0001) with a mean change of -0.96±0.06 (-10.5±0.7 mmol/mol) at 12 weeks. Total 42.83% (n=3365) patients achieved target HbA1c (<7%) at 12 weeks. Conclusion: Initiation of dual therapy with metformin and teneligliptin in drug naïve Indian T2DM patients significantly improved glycaemic control.

Glucometers for Patients with Type 2 Diabetes Mellitus: Are they helpful?

Background: The effectiveness of self-monitoring of blood glucose (SMBG) in type 2 diabetes mellitus (T2DM) patients is debated in the literature. We aimed at elucidating the association and patterns of complications between SMBG use and plasma glucose values.
 Methods: This cross-sectional study comprised 303 participants from outpatient departments with T2DM for over 12 months. We analyzed sociodemographic and clinical variables including: anthropometry, SMBG use, disease duration, treatment modality, complications, plasma glucose level, and glycated hemoglobin level (%).
 Results: The mean duration of T2DM was 93±76 months. Participants were grouped into SMBG users (n=115, 38%) and non-SMBG users (n=188, 62%). The mean fasting plasma glucose levels of SMBG and non-SMBG users were 140.7±42.7 (95% Confidence Interval [95%CI]: 132.72;148.67) mg/dl and 145.4±50 (95%CI: 138.12;152.67) mg/dl (p=0.03), respectively. The mean post-prandial plasma glucose levels of the SMBG and non-SMBG groups were 202±63.42 (95%CI: 190.23;213.76) mg/dl and 209±84.54 (95%CI: 196.56;221.43) mg/dl (p=0.002), respectively. The mean difference in HbA1c among the groups were 8.14±1.69% (95%CI: 7.59;8.68) and 8.15±1.98% (95%CI: 7.27;9.02) (p=0.4), respectively. Hypoglycemia (n=50, 43.5%) was the most common complication. The prevalence of neuropathy (n=5, 4.3%, p=0.036) and cardiovascular disease (n=21, 18.3%, p=0.042) were significantly higher in the SMBG group.
 Conclusion: Although plasma glucose values were significantly lower in the SMBG group, its clinical significance remains questionable. Furthermore, many participants in both the groups had shortfalls in awareness, monitoring, and glycemic control. SMBG use needs to be evaluated in a cohort of patients with T2DM with adequate health awareness.

Teneligliptin Real-World Effectiveness Assessment in Patients with Type 2 Diabetes Mellitus in India: A Retrospective Analysis (TREAT-INDIA 2).

IntroductionTeneligliptin is an antidiabetic medication that has been approved for the management of type 2 diabetes mellitus (T2DM) in Japan, South Korea and India. It is one of the most commonly prescribed antihyperglycaemic agents. The aim of this study was to assess the effectiveness of teneligliptin in improving glycemic control amongst Indian patients with T2DM in a real-world setting.MethodsThis was a retrospective observational study in which a predesigned structured proforma was used to collect information from hospital records of 18 medical centres across India. All participating centres were established primary care hospitals with adequate record keeping, a pre-determined condition in the study design. Data were collected during the period of January 2019 to June 2019. Data extracted from patient records, including glycaemic parameters, concomitant drugs, drug dosage and duration, were collated. The effectiveness of teneligliptin was assessed by analyzing the mean change in glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) at 12 weeks after initiation of teneligliptin.ResultsData from 10,623 patients were available for analysis. The mean age of the enrolled patients was 51.86 ± 11.76 years. At 12 weeks after initiation of teneligliptin as monotherapy or add-on to other medications (combination therapy), the patients showed a signficant decrease from baseline in mean HbA1c, FPG and PPG. Mean HbA1c dropped from 8.66 ± 1.15% at baseline to 7.67 ± 1.28% at 12 weeks (71 ± 12.6 to 60 ± 14 mmol/mol), with a difference of − 0.99% (95% confidence interval [CI] 0.96–1.02) or − 10.8 (95% CI 10.5–11.1) mmol/mol (p < 0.0001). The mean reductions in FPG and PPG were 43.12 mg/dL (2.39 mmol/L) and 87.73 mg/dL (4.87 mmol/L) (both p < 0.0001) respectively. HbA1c (%) reductions with teneligliptin when used as add-on to metformin, add-on to metformin + sulfonylurea combination and add-on to metformin + sulfonylurea + alpha glucosidase inhibitor combination were 0.76% (8.3 mmol/mol), 1.24% (13.6 mmol/mol) and 1.04% (11.4 mmol/mol), respectively. Teneligliptin also significantly reduced HbA1c (1.13% or 12.4 mmol/mol, p < 0.0001) in patients with impaired renal function, without worsening the estimated glomerular filtration rate. Teneligliptin consistently reduced HbA1c across all three age categories tested—by 1% (10.9 mmol/mol) in patients aged < 60 years, by 1.15% (12.6 mmol/mol) in patients aged 60–75 years and by 0.88% (9.6 mmol/mol) in patients aged > 75 years.ConclusionTeneligliptin significantly improved glycaemic parameters in Indian patients with T2DM when prescribed either as monotherapy or as an add-on to one or more other commonly prescribed antihyperglycaemic agents.

Reduced Insulin Clearance and Insulin-Degrading Enzyme Activity Contribute to Hyperinsulinemia in African Americans.

African Americans (AAs) are at a higher risk for developing type 2 diabetes compared with non-Hispanic whites (NHWs). The causal role of β-cell glucose sensitivity (β-GS) and insulin clearance in hyperinsulinemia in AA adults is unclear. Using a cross-sectional study design, we compared β-cell function and insulin clearance in nondiabetic AAs (n = 36) and NHWs (n = 47) after a mixed meal test (MMT). Insulin secretion rate, glucose sensitivity, rate sensitivity, and insulin sensitivity during MMT were derived from a mathematical model. Levels of insulin-degrading enzyme (IDE) and carcinoembryonic antigen-related cell adhesion molecule-1 (CEACAM1), key players in insulin clearance, were measured (by enzyme-linked immunosorbent assay) in hepatic cytosolic fractions from age-, sex-, and body mass index-matched AA and NHW cadaveric donors (n = 10). Fasting and mean postprandial plasma glucose levels were similar in both ethnic groups. AAs had significantly higher fasting and mean postprandial plasma insulin levels. However, fasting ISR, total insulin output, and insulin sensitivity during MMT were not different between the groups. β-GS and rate sensitivity were higher in AAs. Fasting and meal plasma insulin clearance were lower in AAs. Hepatic levels of IDE and CEACAM-1 were similar in AAs and NHWs. Hepatic IDE activity was significantly lower in AAs. In this study, lower insulin clearance contributes to higher plasma insulin levels in AAs. Reduced insulin clearance may be explained by lower IDE activity levels in AAs. Further confirmatory studies are needed to investigate diminished insulin clearance in AAs as a result of lower IDE activity levels.

Teneligliptin real-world efficacy assessment of type 2 diabetes mellitus patients in India (TREAT-INDIA study).

Background and aimsTeneligliptin was introduced in India in May 2015. It has gained popularity and is already widely prescribed in type 2 diabetes mellitus (T2DM). This “real life” data collection was conducted to assess the efficacy of teneligliptin in Indian T2DM patients.MethodsPredesigned structured proforma was used to collect information from the prescribing physicians regarding the efficacy of teneligliptin when prescribed as monotherapy as well as combination therapy with other antidiabetic drugs in T2DM patients. Information on the glycemic parameters at baseline prior to starting teneligliptin and at the end of 3 months therapy was collected. The efficacy was assessed by analyzing the mean change in 3-month values of glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG).ResultsData of 4305 patients was available for analysis. There was statistically significant improvement in mean HbA1c, FPG, and PPG with teneligliptin therapy. Means changes in HbA1c, FPG, and PPG were −1.37%±1.15%, 51.29±35.41 mg/dL, and 80.89±54.27 mg/dL, respectively. Subgroup analysis revealed that HbA1c (%) reduction with teneligliptin when used as monotherapy, add-on to metformin or add-on to metformin plus sulfonylureas combination, add-on to metformin plus alpha glucosidase inhibitor combination or add-on to insulin was 0.98±0.53, 1.07±0.83, 1.46±1.33, 1.43±0.80, and 1.55±1.05, respectively.ConclusionReal-world data suggests that teneligliptin significantly improves glycemic control in Indian patients with T2DM when prescribed either as monotherapy or as an add-on to one or more other commonly prescribed antidiabetic drugs.

Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes: A randomized controlled trial

Aims/IntroductionInsulin degludec/insulin aspart (IDegAsp) is a soluble combination of insulin degludec (70%) and insulin aspart (30%). The present exploratory trial investigated the safety of switching unit‐to‐unit from twice‐daily basal or pre‐mix insulin to twice‐daily IDegAsp in Japanese patients with type 2 diabetes.Materials and MethodsIn this 6‐week, open‐label, parallel‐group, controlled trial, 66 participants were randomized (1:1) to receive either IDegAsp or biphasic insulin aspart 30 (BIAsp 30) twice daily at the same total daily dose as pre‐trial insulin. During the trial, insulin doses were adjusted according to a pre‐specified algorithm to achieve pre‐breakfast and pre‐dinner plasma glucose of 4.4–7.2 mmol/L.ResultsNo severe hypoglycemic episodes occurred. There were no statistically significant differences in rates of confirmed hypoglycemia (rate ratio IDegAsp/BIAsp 30: 0.63, 95% confidence interval: 0.31–1.30) and confirmed nocturnal hypoglycemia (rate ratio: 0.49, 95% confidence interval: 0.10–2.38) for IDegAsp vs BIAsp 30. The hypoglycemia rate for IDegAsp was constant over the 6 weeks of treatment. IDegAsp and BIAsp 30 were both safe and well tolerated. Reduction in fasting plasma glucose was statistically significantly greater for IDegAsp than for BIAsp 30 (estimated treatment difference, IDegAsp‐BIAsp 30: −1.6 mmol/L, 95% confidence interval: −2.4 to −0.8). The apparent decrease in mean postprandial plasma glucose increment (IDegAsp: 4.2–3.8 mmol/L; BIAsp 30: 4.5–2.8 mmol/L) was not statistically significantly different between treatments (estimated treatment difference: 1.0 mmol/L, 95% confidence interval: −0.1 to 2.2).ConclusionsSwitching unit‐to‐unit from basal or pre‐mix insulin to IDegAsp seems not to be associated with any concerns related to hypoglycemia or general safety in Japanese patients with type 2 diabetes.

Efficacy and safety of saxagliptin, a dipeptidyl peptidase-4 inhibitor, in hemodialysis patients with diabetic nephropathy: A randomized open-label prospective trial

AimsSaxagliptin is a dipeptidyl peptidase-4 inhibitor that was approved in Japan for the treatment of type 2 diabetes in 2013. We examined its efficacy and safety in Japanese hemodialysis patients with diabetic nephropathy. MethodsIn this prospective, open-label, parallel-group study, Japanese hemodialysis patients were randomized to receive either oral saxagliptin (2.5mg/day) or usual care (control group) for 24weeks. Before randomization, patients received fixed doses of conventional antidiabetic drugs (oral drugs and/or insulin) for 8weeks; these drugs were continued during the study. Endpoints included changes in glycated albumin (GA), hemoglobin A1c (HbA1c), postprandial plasma glucose (PPG), and adverse events. ResultsBoth groups included 41 patients. Mean GA, HbA1c, and PPG decreased significantly in the saxagliptin group (−3.4%, −0.6% [−7mmol/mol], and −38.3mg/dL, respectively; all P<0.0001) but not in the control group (0%, −0.1% [−1mmol/mol], and −3.7mg/dL, respectively) (P<0.0001, P<0.001, and P<0.0001, respectively). In saxagliptin-treated patients, the reduction in GA was significantly greater when saxagliptin was administered as monotherapy than in combination therapy (−4.2% vs. −3.0%, P=0.012) despite similar baseline values (24.5% vs. 23.3%). Reductions in GA, HbA1c, and PPG were greater in patients whose baseline values exceeded the median (23.8% for GA, 6.6% for HbA1c, and 180mg/dL for PPG). There were no adverse events associated with saxagliptin. ConclusionsSaxagliptin (2.5mg/day) was effective and well tolerated when used as monotherapy or combined with other antidiabetic drugs in Japanese hemodialysis patients with type 2 diabetes. Clinical Trial Registration numberUMIN000018445.

Effects of a Macro-Nutrient Preload on Type 2 Diabetic Patients.

Macro-nutrient preloads given 30 min before regular meals may improve metabolism. The aim was to investigate how type 2 diabetic patients react to a preload consisting of a blend of macro-nutrients with a low-glycemic index (Inzone Preload(®)). In a before-after study design, 30 subjects with type 2 diabetes mellitus (T2DM) were enrolled in a 12-week program. All subjects were given Inzone Preload (43% proteins, 29% carbohydrates, 10% lipids, and 9% fibers, 71 kcal), 30 min before each meal during 12 weeks. Fasting glucose and postprandial 2 h glucose were monitored every second week. Body weight (BW) and waist circumference were measured each month. Fasting plasma glucose, glycosylated hemoglobin, serum lipids, fasting insulin, C-reactive protein, and homeostasis model assessment were evaluated before and after the intervention. Subjective appetite was monitored using visual analogue scales after the Inzone Preload. The dietary intervention significantly influenced several metabolic parameters compared to base line. Inzone Preload treatment reduced mean postprandial plasma glucose levels (12.2 ± 1.2 vs. 10.5 ± 2.0 mmol/L), HbA1c (7.4 ± 0.3 vs. 7.1 ± 0.2%), mean total cholesterol (4.8 ± 0.9 vs. 4.3 ± 0.8 mmol/L), low-density lipoprotein cholesterol (2.8 ± 0.6 vs. 2.5 ± 0.4 mmol/L), and CRP (1.5 ± 1.4 vs. 0.7 ± 0.7 mg/L). BW loss of more than 3% was seen in 13 participants (43%). Feelings of satiety were significantly higher after Inzone Preload than after habitual breakfast (p < 0.05). No significant changes in fasting blood glucose, high-density lipoprotein and total triacylglycerol, HOMA-IR, and HOMA-β were observed. A macro-nutrient preload treatment reduces postprandial glucose, inflammatory markers, and serum lipids in patients with T2DM. Approximately half of the study group also displayed reduced BW.

Glycemic control parameters in insulin-naïve patients with uncontrolled type 2 diabetes referred to endocrinologists, and degree of implementation of the national Spanish consensus for the management of hyperglycemia

Abstract Objective To assess blood glucose in patients with uncontrolled type 2 diabetes mellitus treated with oral antidiabetic drugs in primary care at the time of referral to specialized endocrinologists, and the degree of implementation of the national consensus guidelines of the Spanish Society of Diabetes by evaluating steps one (S1), two (S2), and three (S3) of the escalating therapy. Material and methods Retrospective, observational study where 81 endocrinologists evaluated patients ≥40 years of age referred from primary care between July 2012 and July 2013, treated with 1–2 oral antidiabetic drugs but no insulin therapy, and with glycosylated hemoglobin (HbA1c) levels ≥6.5%. Patients also had to have HbA1c levels and both fasting and postprandial plasma glucose measurements from the previous three months. Results A total of 285 patients (57.6% males) were assessed. Mean (SD) age was 63.1 (9.7) years, mean HbA1c was 8.5 (1.2) %, mean FPG was 171.7 (43) mg/dL, and mean postprandial plasma glucose was 206.8 (50) mg/dL. In primary care, 26.0% of patients were at S1 and 74.0% were at S2. After referral to the endocrinologist, 9.8% of patients moved onto S1, 42.8% onto S2, and 47.4% onto S3. Oral antidiabetic drugs most commonly prescribed in primary care were metformin (90.2%), DPP-4 inhibitors (34.4%), and sulfonylureas (30.5%), while drugs most commonly used in the specialized endocrinology setting were metformin (86%), insulin (56.8%), and DPP-4 inhibitors (49.8%). The most commonly followed guidelines were those of the American Diabetes Association and the consensus guidelines of the Spanish Society of Diabetes, in 77% and 45% of cases respectively. Conclusion Approximately half the patients treated with oral antidiabetic drugs in primary care are prescribed insulin after referral to an endocrinology specialist. The most commonly followed guidelines in specialized care are the American Diabetes Association guidelines.

Parámetros de control glucémico en pacientes con diabetes tipo 2 no insulinizados derivados a consulta de Endocrinología, y grado de implementación del consenso nacional sobre el tratamiento de la hiperglucemia

ObjectiveTo assess blood glucose in patients with uncontrolled type 2 diabetes mellitus treated with oral antidiabetic drugs in primary care at the time of referral to specialized endocrinologists, and the degree of implementation of the national consensus guidelines of the Spanish Society of Diabetes by evaluating steps one (S1), two (S2), and three (S3) of the escalating therapy. Material and methodsRetrospective, observational study where 81 endocrinologists evaluated patients ≥40 years of age referred from primary care between July 2012 and July 2013, treated with 1 to 2 oral antidiabetic drugs but no insulin therapy, and with glycosylated hemoglobin (HbA1c) levels ≥6.5%. Patients also had to have HbA1c levels and both fasting and postprandial plasma glucose measurements from the previous three months. ResultsA total of 285 patients (57.6% males) were assessed. Mean (SD) age was 63.1 (9.7) years, mean HbA1c was 8.5 (1.2) %, mean FPG was 171.7 (43) mg/dL, and mean postprandial plasma glucose was 206.8 (50) mg/dL. In primary care, 26.0% of patients were at S1 and 74.0% were at S2. After referral to the endocrinologist, 9.8% of patients moved onto S1, 42.8% onto S2, and 47.4% onto S3. Oral antidiabetic drugs most commonly prescribed in primary care were metformin (90.2%), DPP-4 inhibitors (34.4%), and sulfonylureas (30.5%), while drugs most commonly used in the specialized endocrinology setting were metformin (86%), insulin (56.8%), and DPP-4 inhibitors (49.8%). The most commonly followed guidelines were those of the American Diabetes Association and the consensus guidelines of the Spanish Society of Diabetes, in 77% and 45% of cases respectively. ConclusionsApproximately half the patients treated with oral antidiabetic drugs in primary care are prescribed insulin after referral to an endocrinology specialist. The most commonly followed guidelines in specialized care are the American Diabetes Association guidelines.

Management of endocrine disease. Effects of telecare intervention on glycemic control in type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

To review the published literature on the effects of telecare intervention in patients with type 2 diabetes and inadequate glycemic control. A review of randomized controlled trials on telecare intervention in patients with type 2 diabetes, and a search of electronic databases such as The Cochrane Library, PubMed, EBSCO, CINAHL, Science Direct, Journal of Telemedicine and Telecare, and China National Knowledge Infrastructure (CNKI), were conducted from December 8 to 16, 2013. Two evaluators independently selected and reviewed the eligible studies. Changes in HbA1c, fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), BMI, and body weight were analyzed. An analysis of 18 studies with 3798 subjects revealed that telecare significantly improved the management of diabetes. Mean HbA1c values were reduced by -0.54 (95% CI, -0.75 to -0.34; P<0.05), mean FPG levels by -9.00 mg/dl (95% CI, -17.36 to -0.64; P=0.03), and mean PPG levels reduced by -52.86 mg/dl (95% CI, -77.13 to -28.58; P<0.05) when compared with the group receiving standard care. Meta-regression and subgroup analyses indicated that study location, sample size, and treatment-monitoring techniques were the sources of heterogeneity. Patients monitored by telecare showed significant improvement in glycemic control in type 2 diabetes when compared with those monitored by routine follow-up. Significant reduction in HbA1c levels was associated with Asian populations, small sample size, and telecare, and with those patients with baseline HbA1c greater than 8.0%.

Newly diagnosed diabetes mellitus patients presenting with proliferative diabetic retinopathy as an initial sign.

To investigate the clinical features of newly diagnosed diabetes mellitus (NDM) patients showing proliferative diabetic retinopathy (PDR) as an initial sign. As a retrospective case series, the medical records of a total of four hundred and thirty-two patients who underwent a vitrectomy due to PDR were reviewed to find the subjects. Of 432 patients, six cases of NDM patients showing PDR as an initial sign were included and analyzed with their systemic and ocular features. the systemic features and ocular features [preoperative and postoperative best corrected visual acuity (BCVA), intraoperative findings]. The mean onset age of visual symptoms was 36.3 years old. The mean serum insulin and C-peptide titer was below the normal range. The mean fasting plasma glucose was 178mg/dL and the mean postprandial 2h plasma glucose was 306mg/dL. The mean HbA1c at diagnosis was 11.02%. In all cases, an acute progressive fibrovascular proliferation was observed. Intraoperative retinal tears were found in three cases of six. The mean preoperative BCVA was +0.67±0.58 logMAR and the mean BCVA at postoperative 6 months was +0.20±0.30 logMAR. All patients were considered to have latent autoimmune diabetes in adults (LADA). A rapid deterioration of kidney function as well as poor diabetic control status at diagnosis was observed in all six cases. The ocular features of the patients showed acute progressive fibrovascular proliferation and relatively favorable postoperative visual acuity.

Alcohol, postprandial plasma glucose, and prognosis of hepatocellular carcinoma

To identify factors associated with prognosis of hepatocellular carcinoma (HCC) after initial therapy. A total of 377 HCC patients who were newly treated at Katsushika Medical Center, Japan from January 2000 to December 2009 and followed up for > 2 years, or died during follow-up, were enrolled. The factors related to survival were first analyzed in 377 patients with HCC tumor stage T1-T4 using multivariate Cox proportional hazards regression analysis. A similar analysis was performed in 282 patients with tumor stage T1-T3. Additionally, factors associated with the period between initial and subsequent therapy were examined in 144 patients who did not show local recurrence. Finally, 214 HCC stage T1-T3 patients who died during the observation period were classified into four groups according to their alcohol consumption and postprandial glucose levels, and differences in their causes of death were examined. On multivariate Cox proportional hazards regression analysis, the following were significantly associated with survival: underlying liver disease stage [non-cirrhosis/Child-Pugh A vs B/C, hazard ratio (HR): 0.603, 95% CI: 0.417-0.874, P = 0.0079], HCC stage (T1/T2 vs T3/T4, HR: 0.447, 95% CI: 0.347-0.576, P < 0.0001), and mean postprandial plasma glucose after initial therapy (< 200 vs ≥ 200 mg/dL, HR: 0.181, 95% CI: 0.067-0.488, P = 0.0008). In T1-T3 patients, uninterrupted alcohol consumption after initial therapy (no vs yes, HR: 0.641, 95% CI: 0.469-0.877, P = 0.0055) was significant in addition to underlying liver disease stage (non-cirrhosis/Child-Pugh A vs B/C, HR: 0649, 95% CI: 0.476-0.885, P = 0.0068), HCC stage (T1 vs T2/T3, HR: 0.788, 95% CI: 0.653-0.945, P = 0.0108), and mean postprandial plasma glucose after initial therapy (< 200 mg/dL vs ≥ 200 mg/dL, HR: 0.502, 95% CI: 0.337-0.747, P = 0.0005). In patients without local recurrence, time from initial to subsequent therapy for newly emerging HCC was significantly longer in the "postprandial glucose within 200 mg/dL group" than the "postprandial glucose > 200 mg/dL group" (log-rank test, P < 0.05), whereas there was no difference in the period between the "non-alcohol group" (patients who did not drink regularly or those who could reduce their daily consumption to < 20 g) and the "continuation group" (drinkers who continued to drink > 20 g daily). Of 214 T1-T3 patients who died during the observation period, death caused by other than HCC progression was significantly more frequent in "group AL" (patients in the continuation and postprandial glucose within 200 mg/dL groups) than "group N" (patients in the non-alcohol and postprandial glucose within 200 mg/dL groups) (P = 0.0016). This study found that abstinence from habitual alcohol consumption and intensive care for diabetes mellitus were related to improved prognosis in HCC patients.

Comparison of Glycated Albumin (GA) and Glycosylated Hemoglobin (A1C) in monitoring glycemic excursions during pregnancy

Objective: To compare GA with A1Cin monitoring glycemic excursions during pregnancy. Research Design and Methods: This study included 30 women with Gestational Diabetes Mellitus (GDM) and an equal number with Normal Glucose Tolerance (NGT). GDM were followed up every 2 weeks till 36 - 37 weeks and NGT were reviewed monthly once. Fasting Plasma Glucose (FPG), Postprandial Plasma Glucose (PPG), Ferritin, GA and A1Cwere estimated. GDM were advised Medical Nutritional Therapy (MNT). Target glycemic control was FPG ~ 5 mmol/L and 2 hr PPG ~ 6.6 mmol/L. Non-responders to MNT were administered insulin. Results: In GDM, mean FPG was 5.16 ± 0.55 mmol/L in the first visit and 4.73 ± 0.52 mmol/L in the last visit. The PPG at first visit was 7.07 ± 1.51 mmol/L and 6.16 ± 0.70 mmol/L in the last visit. The mean GA was 12.48% ± 0.8%, 12.51% ± 0.9%, 12.40% ± 1.0%, 12.30% ± 0.86% and 12.38% ± 0.87% at the first, second, third, fourth and fifth visit respectively. The mean A1Cat first, third and fifth visits was 5.16% ± 0.35%, 5.24% ± 0.29% and 5.21% ± 0.28% respectively. In NGT women, mean FPG at first visit was 4.37 ± 0.37 mmol/L and 4.39 ± 0.43 mmol/L in the last visit. The mean PPG was 5.95 ± 1.01 mmol/L in the first visit and 5.75 ± 1.61 mmol/L in the last visit. The mean GA was 12.17% ± 0.85% in first visit and 12.10% ± 0.77% in the last visit. A1Cwas 4.84% ± 0.31% and 4.91% ± 0.33% in the first and last visit respectively. Conclusions: Glycemic control was observed earlier with GA than A1C. GA is a better indicator of recent past short-term glycemic control in GDM.

An Observational Study on Correlation of Fasting and Postprandial Glycemic Status to various HbA1C Quintiles in Type II Diabetics.

Introduction: The exact contributions of postprandial and fasting glucose increments to overall hyperglycemia remain controversial. An observational prospective study is designed to know the relationship of the defined range of various values of glycosylated hemoglobin with fasting and postprandial glycemic status in pre-diabetics and diabetic subjects. Methods & Material: The 402 patients enrolled for this study are divided into 5 groups (Quintiles) depending upon their HbA1C levels. Results: The mean value of Fasting Plasma Glucose (FPG) and Postprandial Plasma Glucose (PPG) increases with the increasing quintile of HbA1C. The Correlation Coefficient (r- value) for the mean FPG increases with increasing HbA1C Quintiles while that of the mean PPG decreases with higher HbA1C Quintiles. Mean BMI is significantly and positively correlated with HbA1C Quintiles in Groups C, D and E. The occurrence of Diabetic Neuropathy is seen more with rising trends of HbA1C Quintiles. Conclusion: With the severity of diabetes mellitus in relation to increased HbA1C values, attention should be paid more for better control of Fasting Plasma Glucose. When the values of HbA1C are near normal or in pre- diabetic range, glycemic control should be achieved by controlling postprandial plasma glucose since here fasting plasma glucose is negatively correlated. When the values of HbA1C remain at the moderate limit due attention is needed for controlling both the fasting and the postprandial plasma glucose, judiciously.

A survey on the current status of type 2 diabetic patients who failed to achieve the glycemic control target

Objective To investigate the current status of type 2 diabetic patients who failed to achieve the glycemic control target, and provide theoretic evidences for making corresponding strategies. Methods The 2 diabetic patients who failed to reach the glycemic target were recruited from 181 hospitals in 26 cities and received a standard questionnaire, the conditions of their blood glucose level, lifestyle intervention, blood sugar monitoring, and drug therapy were recorded. Totally 3 861 questionnaires with complete information were collected. And the causes which account for glycemic control status were analyzed. Results Among these patients, the mean HbA1c was 7.9%, the mean fasting plasma glucose was 8.2 mmol/L, and the mean postprandial plasma glucose was 11.5 mmol/L. Only 25.6% of patients take their diet control strictly as prescribed and 44. 5% of patients have little exercise. 35. 8% and 47.8% of patients did not monitor their fasting and postprandial plasma glucose,respectively. Glycemic control in the patients aged ＞ 60 years was similar to the younger patients, but the hypoglycemia incidence in the elder group reached 35.5%, which was higher than those in the other 2 groups (20.8% and 21.4%, both P＜0. 05 ). The proportion of patients with mono-therapy and combination therapy was 46. 1% and 51.7%, while the proportion with combination therapy rose in the patients aged ＞60 years (58.7%;Compared with the other age-groups, all P＜0.05 ). 75 % of patients have adjusted their drug administration regimen since initial treatment. Conclusions Inadequate or inappropriate drug therapy regimen is a major cause responsible for this poor glycemic control status. In addition, the unhealthy life styles, insufficient blood sugar monitoring, and poor compliance were also important causes. Thus, for these patients, it is necessary to further enhance patients' education, to improve life style intervention, as well as to select more effective, safer, and compliant drug therapy regimens. Finally, the glycemic control target for the elder patients should be more flexible. Key words: Diabetes mellitus, type 2; Glycemic control; Glycemic target

Fifty-two-week, randomized, multicenter trial to compare the safety and efficacy of the novel glucagon-like peptide-1 analog liraglutide vs glibenclamide in patients with type 2 diabetes.

Aims/Introduction: We compared the safety and efficacy of liraglutide vs glibenclamide in patients with poorly controlled (HbA1c, 7.4-10.4%) type 2 diabetes. Subjects were randomly assigned at a 1:2 ratio to receive 1-year treatment with glibenclamide 1.25-2.5 mg/day or liraglutide 0.9 mg/day. Other oral anti-diabetic drugs (OAD) were prohibited during the trial. Adverse events (AE) were monitored. A total of 400 patients (liraglutide group, n = 268; glibenclamide group, n = 132) were randomized and exposed to trial products. At week 52 vs baseline, HbA1c in the liraglutide and glibenclamide groups was reduced from 9.3 to 7.8% and from 9.2 to 8.2%, respectively. Treatment difference (liraglutide - glibenclamide) at the end of the study was -0.49 (95% CI, -0.71 to -0.27). In the liraglutide and glibenclamide groups, Japan Diabetes Society target HbA1c < 6.9% was achieved by 22.1 and 8.5% of patients, respectively. Fasting plasma glucose fell from 202.8 and 202.1 mg/dL, respectively, to 145.3 and 156.7 mg/dL, respectively. Mean plasma glucose and mean postprandial plasma glucose increment were lower in the liraglutide group. Mean bodyweight was reduced by -0.8 kg in the liraglutide group and increased by 1.0 kg in the glibenclamide group. The proportion of patients reporting at least one treatment-emergent AE (TEAE) in the liraglutide and glibenclamide groups was 91.4 and 91.7%, respectively. Most TEAE were mild in severity. No major hypoglycemic episode was observed. Once-daily administration of liraglutide 0.9 mg for 52 weeks provides more favorable metabolic control and safety profile compared with glibenclamide. Patients on liraglutide lost bodyweight, whereas those on glibenclamide gained weight. This trial was registered with ClinicalTrial.gov (no. NCT00393718). (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00128.x, 2011).

Comparison of effects of insulin aspart three times a day versus insulin detemir once a day on oxidative stress in patients with type 2 diabetes

The main purpose of this study was to investigate whether treatment with long-acting insulin once a day or short-acting insulin three times before each meal daily has a stronger antioxidative effect in patients with type 2 diabetes. These patients had not been treated previously with insulin and were hospitalized for initiation of glycemic control by insulin injection. The patients (n=43) were assigned consecutively and alternately to a group treated with insulin aspart injection three times daily just before each meal and a group treated with insulin detemir injection once daily before bedtime. The results showed that insulin aspart three times a day produced a greater improvement in plasma glucose, and particularly in mean postprandial plasma glucose, compared with insulin detemir once a day (p = 0.0006 for comparison of changes between the two insulin treatments). The amount of insulin needed to approach the target levels of plasma glucose was larger in the insulin aspart group (26.0 ± 10.7 U/day vs. 13.7 ± 4.9 U/day; p < 0.0001). However, only insulin detemir significantly decreased oxidative stress evaluated based on the level of urinary 8-iso-prostaglandin F2α (p = 0.0079), although the mechanisms are not fully evident.

Thirty‐Day Morbidity and Mortality of the Laparoscopic Ileal Interposition Associated with Sleeve Gastrectomy for the Treatment of Type 2 Diabetic Patients with BMI &lt;35: An Analysis of 454 Consecutive Patients

The objective of this study was to evaluate the early results of the laparoscopic interposition of a segment of ileum associated with a sleeve gastrectomy (LII-SG) in order to treat patients with type 2 diabetes mellitus (T2DM) and BMI <35. Data regarding morbidly obese diabetic patients subjected to surgery has consistently been validated. To date, there is scarce information about morbidity and mortality related to the surgical treatment of a "true" typical diabetic population with BMI <35. The procedures were performed in 454 patients (322 male, 132 female). Mean age was 53.6 ± 8 years (range = 27-75). Mean BMI was 29.7 ± 3.6 kg/m(2) (range = 19-34.8). All patients had the diagnosis of T2DM for at least 3 years. Insulin therapy was used by 45.6% of patients. Mean duration of T2DM was 10.8 ± 5.9 years (range = 3-35). Mean hemoglobin A(1c) was 8.8 ± 1.9%. Dyslipidemia was observed in 78.4%, hypertension in 64.8%, nephropathy in 28.6%, retinopathy in 32.6%, neuropathy in 34.6%, and coronary heart disease in 13%. There was no conversion to open surgery. All patients were evaluated postoperatively. Mortality was 0.4%. There were 29 major complications (6.4%) in 22 patients (4.8%) and 51 minor complications (11.2%). Reoperations were performed on 8 patients (1.7%). Twenty patients (4.4%) were readmitted to the hospital. Mean postoperative BMI was 25.8 ± 3.5 kg/m(2). Mean fasting plasma glucose decreased from 198 ± 69 to 128 ± 67 mg/dl and mean postprandial plasma glucose decreased from 262 ± 101 to 136 ± 43 mg/dl. The laparoscopic ileal interposition associated with a sleeve gastrectomy was considered a safe operation with low rates of morbidity and mortality in a diabetic population with BMI < 35. An early control of postprandial glycemia was observed.

Stringent glycaemic control prolongs survival in diabetic patients with end‐stage renal disease on haemodialysis

No suitable index or optimal target for diabetic control has been established for diabetic patients with end-stage renal disease (ESRD) undergoing haemodialysis. To address these issues, the single-centre observational study was conducted. Two hundred and forty-five diabetic ESRD patients (23.3% female; age at initiation of haemodialysis 61.7 ± 10.7 years) at start of haemodialysis between 1 January 1995 and 31 December 2004 were enrolled. Subjects were grouped according to glycaemic control level throughout the observational period as follows: mean postprandial plasma glucose (PPG) <8.9 mmol/L, 8.9 mmol/L ≤ PPG < 10.0 mmol/L, 10.0 mmol/L ≤ PPG < 11.1 mmol/L, 11.1 mmol/L ≤ PPG < 12.2 mmol/L and PPG ≥ 12.2 mmol/L; and HbA1c < 6.0%, 6.0-6.4%, 6.5-6.9% and ≥ 7.0%. Survival was then followed until 31 December 2005. Cumulative survival of groups of 10.0 mmol/L ≤ PPG < 11.1 mmol/L, 11.1 ≤ PPG < 12.2 and PPG ≥ 12.2 mmol/L was significantly lower than that for PPG < 8.9 mmol/L as determined by Kaplan-Meier estimation (P = 0.016, 0.009 and 0.031, respectively; log-rank test). In both uni- and multivariate Cox proportional hazard models, mortality hazard ratios were significantly higher for PPG ≥ 10.0 mmol/L than for PPG < 8.9 mmol/L (P = 0.002-0.021). Kaplan-Meier survival curves grouped by HbA1c levels showed no correlation between HbA1c and survival during the observational period. No significant difference in mortality hazard ratios was seen for any HbA1c groups evaluated by Cox proportional hazard model. Intensive management of diabetic control at a stringent mean on-study PPG < 10.0 mmol/L will improve the life expectancy in diabetic dialysis patients. However, no range of HbA1c values obtained in this study showed any clear difference in clinical outcomes.