Objective:To compare the efficacy and safety of Changsulin ? with Lantus ? in treating patients with type 2 diabetes mellitus (T2DM). Methods:This was a phase Ⅲ, multicenter, randomized, open-label, parallel-group, active-controlled clinical trial. A total of 578 participants with T2DM inadequately controlled on oral hypoglycemic agents were randomized 3∶1 to Changsulin ? or Lantus ? treatment for 24 weeks. The efficacy measures included changes in glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2h postprandial plasma glucose (2hPG), 8-point self-monitoring of blood glucose (SMBG) profiles from baseline, and proportions of subjects achieving targets of HbA1c and FPG. The safety outcomes included rates of hypoglycemia, adverse events (AEs) and anti-insulin glargine antibody. Results:After 24 weeks of treatment, mean HbAlc decreased 1.16% and 1.25%, FPG decreased 3.05 mmol/L and 2.90 mmol/L, 2hPG decreased 2.49 mmol/L and 2.38 mmol/L in Changsulin ? and in Lantus ?, respectively. No significant differences could be viewed in above parameters between the two groups (all P>0.05). There were also no significant differences between Changsulin ? and Lantus ? in 8-point SMBG profiles from baseline and proportions of subjects achieving the targets of HbA1c and FPG (all P>0.05). The rates of total hypoglycemia (38.00% and 39.01% for Changsulin ? and Lantus ?, respectively) and nocturnal hypoglycemia (17.25% and 16.31% for Changsulin ? and Lantus ?, respectively) were similar between the two groups (all P>0.05). Most of the hypoglycemia events were asymptomatic, and no severe hypoglycemia were found in both groups. No differences were observed in rates of AEs (61.77% vs.52.48%) and anti-insulin glargine antibody (after 24 weeks of treatment, 6.91% vs.3.65%) between the two groups (all P>0.05). Conclusions:Changsulin ? shows similar efficacy and safety profiles compared with Lantus ? and Changsulin ? treatment was well tolerated in patients with T2DM.

Objective To analyze the clinical manifestations and possible gene mutation sites of Chinese patients in order to improve the clinician's understanding of CHARGE syndrome. Methods Clinical data were collected and blood samples were obtained from the proband of CHARGE syndrome and their relatives. The peripheral blood DNA was extracted and sequenced by PCR amplification. Mutation sites were verified by Sanger sequencing. Results For the first proband, a heterozygous mutation was detected in the intron 10 of CHD7 gene. His parents and brother did not have mutation. For the second proband, total repeat sequence in exon 7 of CHD7 gene was detected. His father carried the same mutation and his mother did not have mutation. Conclusion For the patients who are diagnosed with CHARGE syndrome based on the clinical manifestations, genetic mutation detection should be proceeded. It is useful for studying possible genetic pathogenesis and enhancing the awareness of clinicians.

To investigate the association of SH2B1 gene rs7359397 polymorphism with overweight and obesity,as well as some related metabolic indicators in Northwest Chinese. Based on the cohort of China National Diabetes and Metabolic disorders Study(2007-2008) in Shanxi province, totally 1210(including 635 overweight and 167 obese) males and 1711(including 781 overweight and 212 obese) females were participated in this study. Matrix assisted laser desorption/ionization time-of-flight mass spectrometry( MALDI-TOF MS) was adopted as the genotyping method. After adjusting for age, the single nucleotide polymorphism rs7359397 of SH2B1 was found to be associated with overweight and obesity in males. The correlation with overweight accords with the dominant(P=0. 02), overdominant(P=0. 03), and log-additive models(P=0. 025), while the correlation with obesity accords with the dominant(P=0. 0078), overdominant(P=0. 0081), and log-additive models(P=0. 015). rs7359397 showed to have a significant association with body mass index, body fat percentage, fasting serum insulin, homeostasis model assessment of insulin resistance in males;and high density lipoprotein-cholesterol in females(P<0. 05). The results show that SH2B1 rs7359397 polymorphism is associated with overweight, obesity, and related metabolic indicators in males of the population studied.

Objective Waist-to-height ratio (WHtR), a measurement of the distribution of body fat, correlated with abdominal obesity indicating that it might be a better predictor of cardiovascular risk and metabolic disease.We, therefore, evaluated optimal WHtR cutoff points according to the risk of framingham risk score ( FRS ) and metabolic syndrome ( MS ) in Chinese .Methods The subjects were from China National Diabetes and Metabolic Disorders Survey during 2007 -2008.Receiver operating characteristic analysis was used to examine the optimal cutoff values of WHtR according to the risk of FRS and MS . Results A total of 27820 women and 18419 men were included in the evaluation .The average age was (45.0 ±13.7 ) years.The proportions of FRS ≥10% and MS increased with WHtR both in men and women.The cutoff points of WHtR for the risk of FRS ≥10%and MS were 0.51, 0.52 in men, and 0.52, 0.53 in women, respectively.When FRS ≥10% and MS were taken into consideration with a certain weights, the pooled cutoffs of WHtR were 0.51 in men, and 0.53 in women, respectively.By using the similar method, the optimized cutoff points were 0.52, 0.51, 0.50 for men and 0.51, 0.53, 0.54 for women in age group 20-39, 40-59 and ≥60 years, respectively.Conclusions The optimal cutoffs of WHtR are 0.51 in men, and 0.53 in women for FRS≥10% in combination with MS indicating that this WHtR cutoff points might be used as indexes to evaluate obesity and risk of obesity -related diseases .

Objective To assess the effectiveness of a novel mobile health patient management system involving doctors, nurses, and patients ( TRIO mode) on glycemic control and self-monitoring of blood glucose (SMBG) compliance among the type 2 diabetes mellitus ( T2DM) patients using basal insulin standardization treatment in China. Methods From April 2014 to April 2015, 416 hospitals in 110 cities of 30 provinces, municipalities, and autonomous regions across China were selected to participate in the program. A Online-to-Offline ( O2O) integrated mobile health patients management system with mobile terminals for the doctors, nurses, and patients was applied in the program for patient education, follow-up, and data collection. For all the newly recruited patients, the baseline information was collected and a first-day patient education program were provided by a designated nurse. In the 12-week follow-up period, data of basal insulin doses and fasting plasma glucose ( FPG) values were collected from the patients by text messages or tracking phone call by the nurse. The patients also received timely standardized patients health education and glycemic control guidance by participating in thepatient education forum anddoctors' hotline in order to help them achieve the glycemic control goals. Results A total of 102 524 patients using basal insulin treatment were eligible and enrolled in the program. 64 420 patients completed the 12 weeks follow-up and provided at least one FPG value at all five follow-ups. In total, 62. 6% (40 334 / 64 420) of the patients reached the FPG control target(FPG≤7. 0 mmol/ L) at the end of follow-up period. The weekly average FPG for patients with complete SMBG data decreased from 10. 58 mmol/ L to 6. 91 mmol/ L while the FPG control rates increased from 13. 4% to 69. 2% . The weekly average FPG for the patients provided incomplete SMBG data decreased from 10. 54 mmol/ L to 7. 13 mmol/ L while the FPG control rates increased from 13. 6% to 62. 2% . The FPG control rates for the patients provided complete SMBG were 1. 74 times higher than those patients provided incomplete SMBG. Based on a GEE model, the average decline of the FPG and the increase of the FPG control rates were significantly better for patients who provided complete SMBG as compared to the patients with incomplete SMBG data. The results of the multivariate logistic regression analysis showed that factors such as receiving the first-day education, participating in the follow-up patient education forum, and the doctors' hotline were significantly associated with the improvement of the SMBG compliance, the treatment adherence, and the FPG control rates. The SMBG compliance and the treatment adherence for patients who completed first-day education were 1. 68 times and 1. 22 times higher, respectively. For the patients who participated in follow-up education activities, their SMBG compliance and treatment adherence were 3. 17 times and 3. 36 times higher, respectively. Conclusion The innovativeTRIOmobile health patient management mode was feasible and effective for better managing the type 2 diabetes patients initiated on basal insulin treatment in China. Active participation in the first-day education program and the follow-up patient education activities can effectively improve the SMBG compliance and the treatment adherence, and therefore play an important role in helping patient achieving FPG control in a faster manner.

Objective Recombinant human parathyroid hormone(1-34) [ rhPTH(1-34)] is the unique anabolic substance acting on the skeleton. The efficacy and safety of long-term administration of rhPTH(1-34) in Chinese postmenopausal women have not been evaluated. This study compared the clinical efficacy and safety of rhPTH(1-34) with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China. Methods A total of453 postmenopausal women with osteoporosis were enrolled in an 18-month, multi-center, randomized, controlled study. They were randomized to receive either rhPTH(1-34) 20 μg(200 U) daily for 18 months, or elcatonin 20 U weekly for 12 months. Lumbar spine ( L1-4) and femoral neck bone mineral density (BMD), fracture rate, back pain as well as biochemical markers of bone turnover ( serum bone-specific alkaline phosphatase was measured by radioimmunoassay; C-telopeptide/ creatinine ( CTX/ Cr) measured by quantitative sandwich enzyme-linked immunosorbent assay) at 6, 12, and 18 months. Adverse events were recorded. Results rhPTH(1-34) increased lumbar BMD more significantly than that did by elcatonin at 6 months( M6), 12 months (M12), and 18 months(M18; 4. 3% vs 1. 94% , 6. 8% vs 2. 72% , 9. 51% vs 2. 86% , P<0. 01). There was only a small but significant increase of femoral neck BMD at M18(2. 64% , P<0. 01) in rhPTH(1-34) groups. There were greater increases in bone turnover markers in the rhPTH(1-34) group than in the elcatonin group at M6, M12, and M18[serum bone-specific alkaline phosphatase(BSAP) 93. 67% vs -3. 56% , 117. 78% vs -4. 12% , 49. 24% vs-5. 81% , P<0. 01; urinary CTX/ Cr 250% vs -29. 5% , 330% vs -41. 4% , 273 % vs -10. 6% , P<0. 01]. rhPTH (1-34) showed similar effect of pain relief as elcatonin. The incidence of clinical fractures was 5. 36% (6 / 112) in elcatonin group and 3. 23% ( 11 / 341 ) in rhPTH ( 1-34 ) group ( P = 0. 303 ). Both treatments were well tolerated. Hypercaluria(9. 38% ) and hypercalcemia(7. 04% ) in rhPTH(1-34) group was transient and caused no clinical symptoms. Pruritus(8. 21% vs 2. 68, P=0. 044) and redness of injection site(4. 40% vs 0, P=0. 024) were more frequent in rhPTH(1-34). Nausea / vomiting(16. 07% vs 6. 16% , P = 0. 001) and hot flushes(7. 14% vs 0. 59% , P<0. 001) were more common in elcatonin group. Conclusion rhPTH(1-34) treatment was associated with greater increases in lumbar spine BMD and bone formation markers. It could increase femoral BMD after 18 months treatment. rhPTH(1-34) could ameliorate back pain effectively. The results of the present study indicate that rhPTH(1-34) is an effective, and safe agent in treating postmenopausal women with osteoporosis.

Alogliptin is a novel dipeptide peptidase-4 inhibitor approved for the treatment of type 2 diabetic mellitus.Numerous clinical studies showed that alogliptin alone or in combination with other oral antidiabetic drugs or insulin can substantially control the level of plasma glucose and glycated hemoglobin (HbA1c) in type 2 diabetic patients.12.5 to 25 mg alogliptin alone once daily reduced HbA1c by 0.56％ to 0.59％ ; while combination with other antidiabetic agents resulted additional HbA1c lowering of 0.4％ to 0.8％.Alogliptin was well tolerated,with low incidence of hypoglycemia and no weight gain.Furthermore,alogliptin displayed no extra cardiovascular risk in patients with cardiovascular diseases.

Objective To compare diabetes(pre-diabetes) prevalence and awareness between Province Shanxi and Fujian .Meth-ods Study data was from China National Diabetes and Metabolic Disorders Study 2007-2008 .5 926 individuals(Shanxi 3 254 ,Fu-jian 2 672) were included as study participants .Standardized questionnaire was used to obtain demographic and lifestyle data .All participants were administered a glucose tolerance test .Results Overall diabetes prevalence was 9 .6% .The diabetes prevalence in Shanxi was lower compared with Fujian(8 .2% vs .11 .3% ,P<0 .001) .Overall pre-diabetes was 15 .4% and no significant differ-ence was found between the two provinces .The awareness of diabetes and pre-diabetes in Shanxi was lower compared with Fujian , although both provinces were not satisfactory .Conclusion Regional differences were showed in diabetes (pre-diabetes) prevalence and awareness between Province Shanxi and Fujian .

Objective To analyze the efficacy and safety of glimepiride treatment as initial monotherapy in newly diagnosed patients with type 2 diabetes mellitus (T2DM).Methods This was a subgroup analysis of the GREAT study,which investigated the efficacy and safety of glimepiride as initial monotherapy in Chinese patients with T2DM.This analysis was performed in 209 patients with disease duration less than 6 months and never received any anti-diabetic drugs.The change of HbA1C,fasting plasm glucose (FPG),2 h postprandial blood glucose (2hPPG),homeostasis model assessment for β-cell function index (HOMA-β),homeostasis model assessment for insulin-resistance index(HOMA-IR),the percentage of patients with HbA1C ＜ 7.0％ at endpoint and the incidence of hypoglycemia were evaluated after 16-weeks treatment.Results After 16-weeks glimepiride treatment,HbA1C value reduced significantly from baseline to endpoint,the reduction was statistically significant (9.21％ ± 1.65％ to 6.69％±0.83％,P＜0.001),69.7％ of the patients achieved HbA1C ＜7.0％ at study endpoint.Glimepiride-treated patients also achieved a significant improvement in FPG [from (10.15 ± 2.13) mmol/L to (7.23 ± 1.50) mmol/L,P＜0.001] and 2hPPG [from (17.21 ±4.14) mmol/L to (11.62 ± 3.34) mmol/L].HOMA-β was improved from 17.21± 15.19 [11.62 (2.90,115.8)] to 41.13 ± 44.12 [28.00 (5.1,360.00)],and HOMA-IR was reduced from 2.32± 1.90 [1.76 (0.60,12.80)] to 2.07 ± 1.74 [1.63 (0.4,12.3)].The incidence of all reported symptomatic hypoglycemia was 18.2％,and the incidence of confirmed hypoglycemia was 3.8％.Conclusion This analysis showed that glimepiride treatment as an initial mono-therapy could effectively improve blood glucose control in newly diagnosed patients with T2DM,and the treatment may improve islet β cell function,and the safety profile is reasonably good.

Objective To characterize the baseline status of Chinese diabetic patients based on data derived from Chinese cohort from SOLVETM study.Methods Patients with type 2 diabetes initiating basal insulin detemir at the decision of the physician were eligible for the study.Data on demographics,medical history,glycemic profile and treatment regimen at baseline were collected by physicians.Results A total of 3272 patients [female 42％,male 58％,mean age (56.2 ± 10.8) years] were included in the study.Their BMI was (25.3 ± 3.3) kg/m2.The duration of diabetes was 4.0 (0.1-27.0) years,and the duration of treatment with oral antidiabetic drugs (OADs) was 3.0(0.0-20.2) years.The proportions of subjects with diabetic macro-and micro-vascular complications were 15.8％ (515 cases) and 27.1％ (866 cases),respectively.The hemoglobin Al c (HbAl c) at baseline was (8.33 ± 1.70) ％,and the fasting blood glucose (FPG) was (9.5 ± 2.6) mmol/L.Conclusions A large proportion of patients with type 2 diabetes remain in poor glycemic control,and the prevalence of diabetic complications is high,which requires optimal therapeutic strategy for the patients with suboptimal glycemic control.