Male Patients with Longstanding Type 2 Diabetes Have a Higher Incidence of Hypoglycemia Compared with Female Patients.

INTRODUCTION: To explore whether there was a gender difference in the risk of hypoglycemia during intensive insulin therapy in patients with longstanding type 2 diabetes (T2D). This was a post hoc analysis of a single-center, open-label and prospective trial. METHODS: All subjects were admitted as inpatients, underwent a standard bread meal test at baseline and received a 7-day continuous subcutaneous insulin infusion (CSII) therapy for achieving glycemic control. Patients then were randomized 1:1 to two groups receiving (1) 4 days of Novo Mix 30 followed by 2 days of Humalog Mix 50; (2) 4 days of Humalog Mix 50 followed by 2 days of Novo Mix 30. All patients were subjected to 4-day retrospective continuous glucose monitoring (CGM) during the last 4 days in this study. The primary outcome was the incidences of hypoglycemia monitored by CGM at the end point. RESULTS: A total of 102 patients met the inclusion criteria and completed the study. Our data revealed that 29 patients (28%) experienced hypoglycemia as detected by CGM at the end point. Binary logistic stepwise regression analysis showed that only gender significantly correlated with hypoglycemia (B = 1.17, p = 0.017). Importantly, male patients had a significantly higher incidence of hypoglycemia than female patients (male = 20/52, female = 9/50, p = 0.022), although male patients required significantly lower insulin doses to maintain glycemic control than female patient (p = 0.00). CONCLUSION: Male patients with longstanding T2D had a higher incidence of hypoglycemia than female patients during intensive insulin therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier, ChiCTR-IPR-15007340.

Metformin add-on continuous subcutaneous insulin infusion on precise insulin doses in patients with type 2 diabetes.

To investigate whether metformin add-on to the continuous subcutaneous insulin infusion (Met + CSII) therapy leads to a significant reduction in insulin doses required by type 2 diabetes (T2D) patients to maintain glycemic control, and an improvement in glycemic variation (GV) compared to CSII only therapy. We analyzed data from our two randomized, controlled open-label trials. Newly diagnoses T2D patients were randomized assigned to receive either CSII therapy or Met + CSII therapy for 4 weeks. Subjects were subjected to a 4-day continuous glucose monitoring (CGM) at the endpoint. Insulin doses and GV profiles were analyzed. The primary endpoint was differences in insulin doses and GV between the two groups. A total of 188 subjects were admitted as inpatients. Subjects in metformin add-on therapy required significantly lower total, basal and bolus insulin doses than those of control group. CGM data showed that patients in Met + CSII group exhibited significant reduction in the 24-hr mean amplitude of glycemic excursions (MAGE), the standard deviation, and the coefficient of variation compared to those of control group. Our data suggest that metformin add-on to CSII therapy leads to a significant reduction in insulin doses required by T2D patients to control glycemic variations.

Comparison of Efficacy and Safety of Lispro and Aspart Evaluated by Continuous Glucose Monitoring System in Patients with Newly Diagnosed Type 2 Diabetes.

OBJECTIVE: To compare the effect of the rapid-acting insulin analogues (RAIAs) aspart (NovoRapid) and lispro (Prandilin) on glycemic variations by continuous glucose monitoring system (CGMS) in patients within newly diagnosed type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) and metformin intensive therapy. METHODS: This is a single-blind randomized controlled trial. A total of 110 patients with newly diagnosed T2DM and with hemoglobin A1c (HbA1c%) above 9% was hospitalized and randomly divided into two groups: group Asp (NovoRapid group) and group Lis (Prandilin group). They all received CSII and metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. C-peptide and insulin and fructosamine were determined. CGMS was continuously applied for 4 days after reaching the glycemic target. RESULTS: There were no significant differences in daily dosages of insulin, fasting plasma C-P and 2 h postprandial C-P and insulin, and fructosamine at the baseline and endpoint between the groups Asp and Lis. No significant differences were seen in the 24 h mean amplitude of glycemic excursions (MAGE), 24 h mean blood glucose (MBG), the standard deviation of the MBG (SDBG), fasting blood glucose, number of glycemic excursion (NGE), and the incidence of hypoglycemia between the two groups. Similarly, no significant differences were found in areas under the curve (AUC) of glucose above 10.0 mmol/L or the decremental area over the curve (AOC) of glucose below 3.9 mmol/L between the two groups. CONCLUSIONS: Lispro and aspart had the similar ability to control the glycemic variations in patients with newly diagnosed T2DM. This study was registered with ClinicalTrials.gov, number ChiCTR-IPR-17010338.

The real world of blood glucose point-of-care testing (POCT) system running in China teaching hospital.

BACKGROUND:  The blood glucose point-of-care testing (POCT) system is important in the decision-making process involving patients suspected of having hypoglycemia. To investigate the real world of the POCT system being used in teaching hospitals in China. METHODS: The survey was conducted by Hisend Research Group from May 2015 to July 2015 in four teaching hospitals in China. The survey questions were referred to the ISO 15197:2013 standard requirements for the use of the POCT system in a hospital setting. RESULTS: A total of 170 subjects were included from 4 hospitals, which included nursing staff, nurse unit managers, employees from the department of medical instruments, and staff members employed by the clinical laboratories in the Tianjin Metabolism Hospital, Nanjing First Hospital, First Affiliated Hospital of Dalian Medical University, and the First hospital affiliated with the Xi'an Transportation University. The average score for the four hospitals surveyed in this study was 66.6, which varied from 46.1 to 79.7. The main factors influencing the scores were the multiple choices of blood-glucose meters, and the quality control assessment. CONCLUSION: Our data indicates that the real world use of the POCT system in hospital settings in China needs more closer adherence to a quality management framework.

Management of glycemic variation in diabetic patients receiving parenteral nutrition by continuous subcutaneous insulin infusion (CSII) therapy.

To compare the continuous subcutaneous insulin infusion (CSII) or insulin glargine based multiple injections (MDI) therapy on glycemic variations in diabetic patients receiving PN outside of intensive care settings. This was a single-center, randomized, open-label trial. Patients with type 2 diabetes (T2D) who were receiving parenteral nutrition (PN) were recruited. After baseline data were collected, recruited patients were then randomized 1:1 to a CSII group or a MDI group. All patients were subjected to a 4-day retrospective Continuous Glucose Monitoring (CGM). The primary endpoint was the differences of the 24-hrs mean amplitude of glycemic excursion (MAGE) in patients receiving the PN therapy between the two groups. A total of 102 patients with T2D receiving PN were recruited. Patients in the CSII group had a significantly decreased mean glucose level (MBG), the standard deviation of MG (SDBG), MAGE, and the coefficient of variation (CV%) compared to those in MDI group (all P < 0.01). Furthermore, we found that the patients who received a bolus insulin dose required maintaining euglycemic control was gradually decreased during the PN period in both groups at the endpoint. The administration of insulin via CSII led to a significant decrease in glycemic variations in patients receiving PN.

Young onset type 2 diabetic patients might be more sensitive to metformin compared to late onset type 2 diabetic patients.

It is unknown whether YOD (young onset diabetes) and LOD (late onset diabetes) require similar insulin doses for intensive insulin therapy with a metformin add-on to achieve glycemic control. We analyzed data from our two previously performed randomized, controlled open-label trials. Patients were randomized to receive either continuous subcutaneous insulin infusion (CSII) therapy or CSII combined with metformin therapy for 4 weeks. The studies concentrated on the differences in the insulin doses used for the two groups. We included 36 YOD (age < 40 yrs) and 152 LOD (age > 40 yrs) patients. YOD patients who received metformin combined with CSII therapy required significantly lower insulin doses to maintain euglycemic control compared to patients with LOD. A multivariate analysis, controlled for gender and the fasting blood concentration, was performed to determine the significance of the differences between groups, particularly with respect to the total and basal insulin doses. There was a trend toward improvement in ß-cell function and insulin resistance in terms of ΔHOMA-B and ΔHOMA-IR in patients with YOD compared to those with LOD. Newly diagnosed T2D patients with YOD required significantly lower insulin doses, particularly basal insulin doses, to maintain glycemic control compared to the LOD patients.

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

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

Features of glycemic variations in drug naïve type 2 diabetic patients with different HbA1c values.

To define the features of glycemic variations in drug naïve type 2 diabetic (T2D) patients with different HbA1c values using continuous glucose monitoring (CGM), a total of 195 drug naïve T2D patients were admitted. The subjects were divided into the following groups: lower HbA1c values (≤8%), moderate HbA1c values (>8% and ≤10%), and higher HbA1c values (>10%). The patients underwent oral glucose tolerance tests and were then subjected to 3-day CGM. The primary endpoint was the differences in the 24-hr mean amplitude of glycemic excursions (MAGE) in patients with different HbA1c values. Patients with higher HbA1c values had larger MAGEs than those in the moderate and lower groups (7.44 ± 3.00 vs. 6.30 ± 2.38, P < 0.05, 7.44 ± 3.00 vs. 5.20 ± 2.35, P < 0.01, respectively). The 24-hr mean glucose concentrations increased incrementally in the patients with lower, moderate and higher HbA1c values. Moreover, the patients with higher HbA1c values exhibited higher peak glucose concentrations and prolongation in the time to peak glucose. Patients with higher HbA1c values had larger MAGE compared with those with lower and moderate HbA1c values. Our data indicated patients with higher HbA1c values should receive special therapy aimed at reducing the larger glycemic variations.

Continuous Glucose Monitoring in Newly Diagnosed Type 2 Diabetes Patients Reveals a Potential Risk of Hypoglycemia in Older Men.

Objectives. We performed continuous glucose monitoring (CGM) to define the features of patients with newly diagnosed type 2 diabetes (T2D) before and after Continuous Subcutaneous Insulin Infusion (CSII) therapy. Methods. This was a retrospective analysis. Newly diagnosed T2D patients (106) were admitted from eight centers in China. They were divided into a younger patient group (<60 years) and an older patient group (≥60 years). Each group was further divided into male and female patients. CSII therapy was maintained for 3 weeks after the glycemic target was reached. CGM was performed 2 times before and after completion of insulin treatment. Results. CGM data showed the expected significant improvement of mean amplitude glycemic excursion (MAGE) with CSII therapy. The older patients had lower hourly glucose concentrations from 0200 to 0700 o'clock compared to the younger patients at baseline. Surprisingly, in the older patient group, the male patients had a potential risk of hypoglycemia after CSII therapy, especially during periods from 2300 to 2400 and 0400 to 0600. Conclusions. Our data suggested that older male patients with newly diagnosed T2D may have lower nocturnal glucose concentrations. This may potentially increase the risk of nocturnal hypoglycemia during CSII therapy. This study was registered with Chinese Clinical Trial Registry, number CliCTR-TRC-11001218.

Exenatide Add-on to Continuous Subcutaneous Insulin Infusion Therapy Reduces Bolus Insulin Doses in Patients with Type 2 Diabetes: A Randomized, Controlled, Open-Label Trial.

INTRODUCTION: The objective of this study was to investigate the effect of adding exenatide to continuous subcutaneous insulin infusion (CSII) therapy on the precise insulin doses required by type 2 diabetic patients to maintain glycemic control. METHODS: This was a single-center, randomized, controlled, open-label trial. Uncontrolled T2D patients were recruited between March 2010 and November 2011 at Nanjing First Hospital, China. Subjects were randomly assigned (1:1) to either an exenatide add-on to CSII group or a CSII therapy only (i.e., control) group (n = 18, respectively) for 5 weeks. Patients were subjected to 3 days of continuous glucose monitoring (CGM) during the screening period and after therapy. The precise insulin doses, the times taken by the patients to achieve euglycemic control, and the mean amplitude of glycemic excursion (MAGE) at the endpoint were compared between the two groups. The primary endpoint was precise insulin dose differences between groups from baseline to the endpoint. RESULTS: A total of 36 subjects were admitted as inpatients. Patients in the exenatide add-on therapy group needed less insulin titration time to achieve glycemic control (3.67 ± 1.33 vs. 4.78 ± 1.00 days, P = 0.028) and significantly lower bolus insulin doses than the control group at the endpoint (total bolus, 0.13 ± 0.03 vs. 0.17 ± 0.04 U/kg, P = 0.02, breakfast bolus, 0.05 ± 0.01 vs. 0.06 ± 0.01 U/kg, P = 0.01, lunch bolus, 0.04 ± 0.01 vs. 0.06 ± 0.01 U/kg, P = 0.01, dinner bolus, 0.04 ± 0.01 vs. 0.05 ± 0.01 U/kg, P = 0.01, respectively). Moreover, the CGM data showed that patients in the exenatide add-on therapy group exhibited a significant reduction in MAGE as compared to the control group (2.96 ± 1.14 vs. 4.21 ± 1.39 mmol/L, P = 0.012). CONCLUSION: Our data suggest that adding exenatide therapy to CSII therapy leads to an improvement in glycemic excursions and the use of smaller bolus insulin doses. TRIAL REGISTRATION: Chinese Clinical Trial Registry identifier, ChiCTR-PPR-15007045.

Analysis of the add-on effect of α-glucosidase inhibitor, acarbose in insulin therapy: A pilot study.

The aim of the present study was to evaluate the add-on effect of acarbose therapy in oxidative stress, and the lipid and inflammatory profiles of patients with type 2 diabetes mellitus (T2DM) treated with insulin. This was an open and unblended study. Patients (n=134) with T2DM (haemoglobin A1c range, 9.0-12.0%) were recruited. After continuous subcutaneous insulin infusion for 7 days for initial rapid correction of hyperglycaemia, a premixed insulin titration period (duration, 4-6 days) subsequently followed. Patients were then randomized (1:1) into two groups as follows: An acarbose plus pre-mixed 30/70 insulin group or a pre-mixed 30/70 insulin only group; each group received treatment for 2 weeks. Plasma high-sensitivity C-reactive protein (Hs-CRP), 8-iso-prostaglandin F2α (8-iso PGF2α), tumor necrosis factor-α (TNF-α), interleukin (IL)-1ß, and IL-6 levels were measured before and after therapy. Patients that received acarbose plus insulin demonstrated greater reduction in 8-iso PGF2α, Hs-CRP, TNF-α, IL-1ß and IL-6 levels when compared with the insulin only patients. Thus, acarbose add-on insulin therapy was identified to be associated with greater improvements in oxidative stress and inflammation in patients with T2DM when compared with those that received insulin only therapy.

Influence of Dapagliflozin on Glycemic Variations in Patients with Newly Diagnosed Type 2 Diabetes Mellitus.

Objectives. To observe changes in blood glycemic variations and oxidative stress level before and after dapagliflozin treatment in patients with newly diagnosed T2DM. Methods. This was a randomized, double-blind, placebo-controlled, phase 3 trial. A total of 28 patients with newly diagnosed T2DM with HbA1c levels of 7.5-10.5% were randomly selected to receive dapagliflozin or placebo treatment for 24 weeks. After baseline data were collected, we analyzed glycemic variations and plasma 8-iso PGF2α level at baseline and at the endpoint. Primary outcome was the changes of mean amplitude glycemic excursion (MAGE) within groups. Results. After 24-week dapagliflozin therapy, our data showed the significant improvement of MAGE with dapagliflozin therapy (P = 0.010). Compared with control group, patients in dapagliflozin group exhibited reduction in 24-hour MBG (P = 0.026) and lower mean plasma glucose concentrations, especially during periods from 2400 to 0200 and 1300 to 1800 (P < 0.05, resp.). In addition, plasma 8-iso PGF2α level was notably decreased in the treatment group compared to the control group (P = 0.034). Conclusions. In conclusion, this study shows the ability of dapagliflozin to improve glycemic variations and associate with reduction of oxidative stress in patients with T2DM, which may benefit the cardiovascular system.

Effects of saxagliptin add-on therapy to insulin on blood glycemic fluctuations in patients with type 2 diabetes: A randomized, control, open-labeled trial.

BACKGROUND: To investigate whether saxagliptin add-on therapy to continuous subcutaneous insulin infusion (CSII) further improve blood glycemic control than CSII therapy in patients with newly diagnosed type 2 diabetes (T2D). METHODS: This was a single-center, randomized, control, open-labeled trial. Newly diagnosed T2D patients were recruited between February 2014 and December 2015. Subjects were divided into saxagliptin add-on therapy to CSII group (n = 31) and CSII therapy group (n = 38). The treatment was maintained for 4 weeks. Oral glucose tolerance test was performed at baseline. Serum samples were obtained before and 30 and 120 minutes after oral administration for glucose, insulin, and C-peptide determination. Continuous glucose monitoring (CGM) was performed before and endpoint. RESULTS: A total of 69 subjects were admitted. After 4-week therapy, CGM data showed that patients with saxagliptin add-on therapy exhibited further improvement of mean amplitude glycemic excursion (MAGE), the incremental area under curve of plasma glucose >7.8 and 10 mmol/L compared with that of control group. In addition, the hourly mean blood glucose concentrations, especially between 0000 and 0600 in patient with saxagliptin add-on therapy, were significantly lower compared with that of the control patients. Furthermore, patients in saxagliptin add-on group needed lower insulin dose to maintain euglycemic control. In addition, severe hypoglycemic episode was not observed from any group. CONCLUSION: Saxagliptin add-on therapy to insulin had the ability of further improve blood glycemic controlling, with lower insulin dose required by patients with T2D to maintain euglycemic controlling.

PGE1 improves diabetic peripheral neuropathy in patients with type 2 diabetes.

BACKGROUND: Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes. We aim to investigate the efficacy of Prostaglandin E1 (PGE1) treatment in addition to intensive insulin therapy on DPN in patients with type 2 diabetes. METHODS: Seventy-seven patients with DPN received daily intravenous injection of Prostaglandin E1 (PGE1) in lipid microspheres (Lipo-PGE1) for 10days as an additional therapy to standard glucose control therapy (PGE1 group). Another 42 patients with DPN receiving only standard glucose control therapy (intensive insulin therapy) acted as a control group. Michigan neuropathy screening instrument (MNSI) score, neurophysiology examination, transcutaneous oxygen sensory threshold, and ankle-brachial index (ABI) were measured to evaluate the efficacy of PGE1 treatment as compared with control group. RESULTS: Standard glucose control therapy decreased plasma glucose to a similar level in both PGE1 and control groups. Compare to control group, PGE1 group displayed improvement in several nerve electrophysiological indexes. MNSI score was significantly improved in patients who received PGE1 treatment compared with the control group (p<0.001) after 10days of PGE1 treatment. Similarly, nerve conduction velocity and foot sensory thresholds (p<0.05 for all) also significantly improved compared with the control group after 10days of PGE1 treatment. However, only intensive insulin therapy did not improve any neural function. CONCLUSIONS: Lipo-PGE1 can effectively improve neural function of patients with DPN.

Blood Glucose Fluctuations in Type 2 Diabetes Patients Treated with Multiple Daily Injections.

To compare blood glucose fluctuations in type 2 diabetes mellitus (T2DM) patients were treated using three procedures: insulin intensive therapy which is continuous subcutaneous insulin infusion (CSII), MDI3 (three injections daily), and MDI4 (four injections daily). T2DM patients were hospitalized and were randomly assigned to CSII, aspart 30-based MDI3, and glargine based MDI4. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. After completing the baseline assessment, 6-day continuous glucose monitoring (CGM) was performed before and after completion of insulin treatment. Treatment with CSII provided a greater improvement of blood glucose fluctuations than MDI (MDI3 or MDI4) therapy either in newly diagnosed or in long-standing T2DM patients. In long-standing diabetes patients, the MDI4 treatment group had significantly greater improvement of mean amplitude glycemic excursion (MAGE) than the MDI3 treatment group. However, in patients with newly diagnosed diabetes, there were no significant differences in the improvement of MAGE between MDI3 and MDI4 groups. Glargine based MDI4 therapy provided better glucose fluctuations than aspart 30-based MDI3 therapy, especially in long-standing T2DM patients, if CSII therapy was not available.

Influence of Acarbose on Plasma Glucose Fluctuations in Insulin-Treated Patients with Type 2 Diabetes: A Pilot Study.

Background and Aims. To evaluate the effect of adding acarbose on glycemic excursions measured by continuous glucose monitoring system (CGMS) in patients with type 2 diabetes mellitus (T2DM) already on insulin therapy. Materials and Methods. This was an opened and unblended study. 134 patients with T2DM were recruited. After initial rapidly corrected hyperglycaemia by continuous subcutaneous insulin infusion (CSII) for 7 d, a 4-6-day premixed insulin titration period subsequently followed. Patients were then randomized 1 : 1 to acarbose plus insulin group or insulin therapy group for 2 weeks. CGMS was used to measure glucose fluctuations for at least 3 days after therapy cessation. Results. Patients in acarbose plus insulin group achieved a significant improvement of MAGE compared to that of insulin therapy only group (5.56 ± 2.16 versus 7.50 ± 3.28 mmol/L, P = 0.044), accompanied by a significant decrease in the incremental AUC of plasma glucose concentration above 10.0 mmol/L (0.5 [0.03, 0.9] versus 0.85 [0.23,1.4] mmol/L per day, P = 0.037). Conclusions. Add-on acarbose to insulin therapy further improves glucose fluctuation in patients with T2DM. This study was registered with ClinicalTrials.gov registration number ChiCTR-TRC-11001218.

An analysis of the relationship between ankle-brachial index and estimated glomerular filtration rate in type 2 diabetes.

We investigated the relationship between peripheral arterial disease (PAD) and renal function in patients with type 2 diabetes mellitus (T2DM). We enrolled 2057 hospitalized patients with T2DM and measured kidney function and ankle-brachial index (ABI). The estimated glomerular filtration rate (eGFR) was derived using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and ABI was grouped as low (<0.9), low-normal (0.9-1.09), normal (1.1-1.3), and high (>1.3). Logistic regression was used to evaluate the associations of eGFR with ABI. Generally speaking, the ABI was negatively correlated with systolic blood pressure, fasting C-peptide, total cholesterol, and low-density lipoprotein cholesterol while positively correlated with body mass index (P < .05 to <.01). Only a low ABI was positively correlated with eGFR (P < .01). In addition to the association of the ABI with cardiovascular events, stroke, and PAD, ABI may also predict the change in renal function in patients with T2DM.

Fulminant type 1 diabetes mellitus: a study of nine cases.

OBJECTIVE: The study aims to explore the prevalence and clinical features of fulminant type 1 diabetes mellitus (F1DM). SUBJECTS AND METHODS: We analyzed 11,202 patients who were diagnosed having diabetes and admitted to the Department of Endocrinology, Nanjin First Hospital, Nanjin, China, from September 2005 to April 2011. Among 198 patients classified having type 1 diabetes mellitus (T1DM), nine patients were diagnosed having F1DM. Clinical features of F1DM were analyzed and compared with typical T1DM. RESULTS: The prevalence of F1DM was 4.5% (nine of 198 T1DM patients) in this study. F1DM patients had significantly high levels of random blood glucose (40±9 mmol/L). However, glycated hemoglobin (7.1±1.0%) and C-reactive peptide (0.21±0.15 µg/L) at 2 h postprandial were significantly lower in F1DM patients compared with typical T1DM patients. Six of them had flu-like symptoms. Five of them showed gastrointestinal symptoms. Three patients experienced disturbance of consciousness. However, none of these symptoms was found in patients with typical T1DM. A continuous intravenous insulin infusion therapy using a portable pump was given during the acute phase to control hyperglycemia and ketoacidosis. All F1DM patients survived after treatment. CONCLUSION: In this single hospital-based study, nine Chinese patients met the criteria for diagnosis of F1DM. Although F1DM may be fatal, prompt treatment is required and useful to rescue these patients.

Effect of exenatide on inflammatory and oxidative stress markers in patients with type 2 diabetes mellitus.

AIM: This study was designed to determine the effect of exenatide on inflammatory and oxidative stress markers in type 2 diabetes mellitus (T2DM) patients who were suboptimally controlled with metformin and/or sulfonylurea. SUBJECTS AND METHODS: Twenty-three patients with T2DM with inadequate glucose control were randomly divided into two groups: exenatide group (E group) (12 patients, 5 µg b.d. × 4 weeks followed by 10 µg b.d. × 12 weeks) and placebo group (P group) (11 patients). Glycosylated hemoglobin (HbA1c), the seven-point glucose profile, daily mean glucose, and glycemic excursion were determined. The effects of exenatide on 8-iso-prostaglandin F2α (PGF2α), monocyte chemoattractant protein-1 (MCP-1), and high-sensitivity C-reactive protein (hs-CRP) were investigated. RESULTS: Exenatide treatment reduced body weight and body mass index (BMI) and improved HbA1c, the seven-point glucose profile, and daily mean glucose compared with placebo (P < 0.05). Limited glycemic excursion was found in the E group compared with the P group (P < 0.05), including a smaller SD and postprandial glucose excursion. In addition, the oxidative stress maker PGF2α was significantly reduced by exenatide treatment (P < 0.05). The inflammatory markers hs-CRP and MCP-1 were also significantly reduced in the E group compared with the P group (P < 0.05). PGF2α was significantly correlated with glycemic excursion (P < 0.05), whereas MCP-1 was significantly correlated with body weight, BMI, glycemic excursion, and HbA1c (P < 0.05 for all). CONCLUSIONS: Exenatide treatment reduced patient body weight and BMI, improved HbA1c and the seven-point glucose profile, reduced daily mean glucose, limited glycemic excursion, and reduced oxidative stress and inflammatory markers in patients of T2DM having inadequate glucose control.

Berberine lowers blood glucose in type 2 diabetes mellitus patients through increasing insulin receptor expression.

Our previous work demonstrated that berberine (BBR) increases insulin receptor (InsR) expression and improves glucose utility both in vitro and in animal models. Here, we study the InsR-up-regulating and glucose-lowering activities of BBR in humans. Our results showed that BBR increased InsR messenger RNA and protein expression in a variety of human cell lines, including CEM, HCT-116, SW1990, HT1080, 293T, and hepatitis B virus-transfected human liver cells. Accordingly, insulin-stimulated phosphorylations of InsR beta-subunit and Akt were increased after BBR treatment in cultured cells. In the clinical study, BBR significantly lowered fasting blood glucose (FBG), hemoglobin A(1c), triglyceride, and insulin levels in patients with type 2 diabetes mellitus (T2DM). The FBG- and hemoglobin A(1c)-lowering efficacies of BBR were similar to those of metformin and rosiglitazone. In the BBR-treated patients, the percentages of peripheral blood lymphocytes that express InsR were significantly elevated after therapy. Berberine also lowered FBG effectively in chronic hepatitis B and hepatitis C patients with T2DM or impaired fasting glucose. Liver function was improved greatly in these patients by showing reduction of liver enzymes. Our results confirmed the activity of BBR on InsR in humans and its relationship with the glucose-lowering effect. Together with our previous report, we strongly suggest BBR as an ideal medicine for T2DM with a mechanism different from metformin and rosiglitazone.