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PubMed | Community Research, XING, China Japan Friendship Hospital, Novo Nordisk AS and 2 more.
Type: Journal Article | Journal: Drugs in R&D | Year: 2016

To lower the barrier for initiating insulin treatment and obtain adequate glycemic control in type 2 diabetes mellitus (T2DM), new basal insulin preparations with improved pharmacological properties and consequently a lower risk of hypoglycemia are needed. The objective of this trial was to confirm the efficacy and compare the safety of insulin degludec (IDeg) with insulin glargine (IGlar) in a multinational setting with two thirds of subjects enrolled in China.This was a 26-week, randomized, open-label, parallel-group, treat-to-target, non-inferiority trial in 833 subjects with T2DM (48% were female, mean age 56years, diabetes duration 8years), inadequately controlled on oral antidiabetic drugs (OADs). Subjects were randomized 2:1 to once-daily IDeg (555 subjects) or IGlar (278 subjects), both with metformin. The primary endpoint was the change from baseline in glycosylated hemoglobin (HbA1c) after 26weeks.The completion rate was high (IDeg 94.2%; IGlar 91.4%). Mean HbA1c decreased from 8.3 to 7.0% in both groups. Estimated treatment difference (ETD) [95% confidence interval (CI)] IDeg-IGlar in change from baseline was -0.05% points [-0.18 to 0.08], confirming the non-inferiority of IDeg to IGlar. The proportion of subjects achieving HbA1c <7.0% was 54.2 and 51.4% with IDeg and IGlar, respectively (estimated odds ratio [95% CI] IDeg/IGlar: 1.14 [0.84 to 1.54]). The mean decrease in fasting plasma glucose, self-measured plasma glucose profiles, and insulin dose were similar between groups. Numerically lower rates of overall (estimated rate ratio [95% CI] IDeg/IGlar: 0.80 [0.59 to 1.10]) and nocturnal (0.77 [0.43 to 1.37]) confirmed hypoglycemia were observed with IDeg compared with IGlar. No treatment differences in other safety parameters were found. Subjects were more satisfied with the IDeg device compared with the IGlar device as reflected by the total Treatment Related Impact Measures-Diabetes Device score (ETD [95% CI] IDeg-IGlar: 2.2 [0.2 to 4.3]).IDeg provided adequate glycemic control non-inferior to IGlar and a tendency for a lower hypoglycemia rate. IDeg is considered suitable for initiating insulin therapy in T2DM patients on OADs requiring intensified treatment.Clinicaltrials.gov NCT01849289.


PubMed | Chinese Academy of Sciences, Sun Yat Sen University, Taihe hospital, Peking Union Medical College and 11 more.
Type: | Journal: Journal of diabetes | Year: 2016

The objective of this study was to evaluate the efficacy and safety of Polyethylene Glycol Loxenatide Injection (PEX168) in Chinese type 2 diabetic patients.In this multicenter, randomized, double-blinded, parallel, placebo-controlled clinical trial, patients treated with a stable dose of metformin (1500mg/day) for 12weeks and HbA1c between 7%-11% were enrolled. Subjects were randomly divided into three groups at a ratio of 1:1:1. Subjects received subcutaneous injection of placebo, PEX168-100g, or PEX168-200g once a week for 12weeks. All subjects continuously received metformin every day.After 12weeks of treatment, the adjusted least-squares mean (95%CI) of HbA1c reduction from the baseline values in the PEX168 groups was significantly higher than that in the placebo group [ -1.02% (95%CI: -1.33 to -0.71;100g group); -1.36% (95%CI: -1.68 to -1.04; 200g group); and 0.13% (95%CI: -0.20 to 0.45; placebo group) (P<0.05)]. After treatment, 50% (100g group) and 60.5% (200g group) of the subjects achieved HbA1c<7% ([both P<0.01 vs placebo group (11.1%)]. The most frequent adverse reactions at the 100-200g range of PEX168 groups were mild to moderate dose-dependent gastrointestinal reactions. No incidence of hypoglycemia events or pancreatitis events was recorded.Continuous 12weeks of PEX168 treatment showed excellent safety and efficacy in type 2 diabetic patients whose glucose was not well controlled after metformin alone.


Yang W.,China Japan Friendship Hospital | Zhu L.,Bethune International Peace Hospital | Meng B.,Inner Mongolia University for Nationalities | Liu Y.,Jilin University | And 11 more authors.
Journal of Diabetes Investigation | Year: 2016

Aims/Introduction: The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). Materials and Methods: In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. Results: Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA1c target without confirmed hypoglycemia throughout the trial in the subject-driven and investigator-driven groups, respectively. Conclusions: Subject-titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision. © 2016 Asian Association for the Study of Diabetes and Wiley Publishing Asia Pty Ltd.


Zhang T.,China Pharmaceutical University | Xiong H.,China Pharmaceutical University | Dahmani F.Z.,China Pharmaceutical University | Sun L.,China Pharmaceutical University | And 4 more authors.
Nanotechnology | Year: 2015

Based on the complementary effects of doxorubicin (DOX), all-trans retinoic acid (ATRA) and low molecular weight heparin (LMWH), the combination therapy of DOX, ATRA and LMWH was expected to exert the enhanced anti-tumor effects and reduce the side effects. In this study, amphiphilic LMWH-ATRA conjugate was synthesized for encapsulating the DOX. In this way, DOX, ATRA and LMWH were assembled into a single nano-system by both chemical and physical modes to obtain a novel anti-tumor targeting drug delivery system that can realize the simultaneous delivery of multiple drugs with different properties to the tumor. LMWH-ATRA nanoparticles exhibited good loading capacities for DOX with excellent physico-chemical properties, good biocompatibility, and good differentiation-inducing activity and antiangiogenic activity. The drug-loading capacity was up to 18.7% with an entrapment efficiency of 78.8%. It was also found that DOX-loaded LMWH-ATRA nanoparticles (DHR nanoparticles) could be efficiently taken up by tumor cells via endocytic pathway, and mainly distributed in cytoplasm at first, then transferred into cell nucleus. Cell viability assays suggested that DHR nanoparticles maintained the cytotoxicity effect of DOX on MCF-7 cells. Moreover, the in vivo imaging analysis indicated that DiR-loaded LMWH-ATRA nanoparticles could target the tumor more effectively as compared to free DiR. Furthermore, DHR nanoparticles possessed much higher anticancer activity and reduced side effects compared to free drugs solution. These results suggested that DHR nanoparticles could be considered as a promising targeted delivery system for combination cancer chemotherapy with lower adverse effects. © 2015 IOP Publishing Ltd.


Yu Z.,Jilin University | Zhao G.,Jilin University | Zhao Z.,Siping Central Peoples Hospital | Li Y.,Jilin University | Xie G.,Jilin University
Oncology Letters | Year: 2016

Dumbbell-shaped hypoglossal Schwannomas of the 12th cranial nerve are extremely rare, and complete removal of these tumors is difficult, particularly in elderly patients with recurrent tumors. The present study reports the case of a 61-year-old male with a giant recurrent dumbbell-shaped hypoglossal schwannoma that arose extracranially. The recurrent tumor was completely removed in a one-stage surgical procedure via the far lateral suboccipital approach in combination with the transcervical approach. To the best of our knowledge, such a lesion has not been reported previously. The life expectancy and natural course of the disease are important factors to take into account when considering the individual end-point of surgery in patients. More studies on hypoglossal schwannomas are required, particularly cases in which the hypoglossal schwannoma was not totally resected, not only in order to develop more definitive and secure surgical treatments, but also to reduce the resultant unnecessary suffering of patients. © Spandidos Publications 2015. All rights reserved.


Yu Z.,Jilin University | Zhao G.,Jilin University | Zhang Z.,Jilin University | Li Y.,Jilin University | And 4 more authors.
Experimental and Therapeutic Medicine | Year: 2016

Glioblastoma (GBM) is the most common and devastating primary malignant intracranial tumor in adults. The current first-line treatment for patients with newly diagnosed GBM is surgical resection followed by radiotherapy plus concomitant and adjuvant temozolomide. This treatment protocol may prolong the survival period of the patient, however it is not curative and more effective therapeutic strategies are required. GBM is a type of highly vascularized tumor with increased expression levels of vascular endothelial growth factor (VEGF), which is a significant mediator of angiogenesis. Since angiogenesis is essential for tumor growth, anti-angiogenic therapies hold potential for the treatment of GBM, and targeting VEGF has demonstrated promising results in previous studies. Bevacizumab (BEV) is a recombinant humanized monoclonal antibody that inhibits VEGF and is approved by the US Food and Drug Administration as a monotherapy treatment for patients with recurrent GBM and is associated with manageable toxicity. Previous studies have demonstrated that BEV may be an effective treatment for recurrent GBM, with prolonged progression-free survival and overall survival, and maintained patient quality of life and functional status. The present review article briefly outlines the mechanism of action of BEV and summarizes the current literature and clinical trial research on the role of BEV for the treatment of patients with recurrent and newly diagnosed GBM. © 2016, Spandidos Publications. All rights reserved.


Jiang L.,Siping Central Peoples Hospital | Jiang L.,Eastern Liaoning University | Chang J.,Siping Central Peoples Hospital | Zhang Q.,Siping Central Peoples Hospital | And 2 more authors.
Cancer Investigation | Year: 2013

The mature microRNA hsa-miR-125a-3p is derived from the 3′ end of pre-miR-125a. Here, we reported that hsa-miR-125a-3p suppressed proliferation and induced apoptosis in A549 cells. In addition, wild-type p53 mRNA and protein expression was increased by hsa-miR-125a-3p over-expression. Moreover, blocking wild-type p53 attenuated the effect of hsa-miR-125a-3p on apoptosis but could not restore completely. In p53-deficient cell line H1299, hsa-miR-125a-3p still induced apoptosis. Taken together, these data suggest that hsa-miR-125a-3p induces apoptosis not only via the p53 pathway in human lung cancer cells. These results provide new insight into the roles of the miR-125a family in lung cancer. © 2013 Informa Healthcare USA, Inc.


PubMed | Jilin University and Siping Central Peoples Hospital
Type: Journal Article | Journal: Experimental and therapeutic medicine | Year: 2016

Glioblastoma (GBM) is the most common and devastating primary malignant intracranial tumor in adults. The current first-line treatment for patients with newly diagnosed GBM is surgical resection followed by radiotherapy plus concomitant and adjuvant temozolomide. This treatment protocol may prolong the survival period of the patient, however it is not curative and more effective therapeutic strategies are required. GBM is a type of highly vascularized tumor with increased expression levels of vascular endothelial growth factor (VEGF), which is a significant mediator of angiogenesis. Since angiogenesis is essential for tumor growth, anti-angiogenic therapies hold potential for the treatment of GBM, and targeting VEGF has demonstrated promising results in previous studies. Bevacizumab (BEV) is a recombinant humanized monoclonal antibody that inhibits VEGF and is approved by the US Food and Drug Administration as a monotherapy treatment for patients with recurrent GBM and is associated with manageable toxicity. Previous studies have demonstrated that BEV may be an effective treatment for recurrent GBM, with prolonged progression-free survival and overall survival, and maintained patient quality of life and functional status. The present review article briefly outlines the mechanism of action of BEV and summarizes the current literature and clinical trial research on the role of BEV for the treatment of patients with recurrent and newly diagnosed GBM.


PubMed | Siping central Peoples Hospital and China Pharmaceutical University
Type: Journal Article | Journal: International journal of pharmaceutics | Year: 2015

The purpose of this study was to develop a novel featured and flexible methotrexate (MTX) formulation, in which MTX was physically entrapped and chemically conjugated in the same drug delivery system. A series of poloxamer-MTX (p-MTX) conjugates was synthesized, wherein MTX was grafted to poloxamer through an ester bond. p-MTX conjugates could self-assemble into micelle-like structures in aqueous environment and the MTX end was in the inner-core of micelles. Moreover, free MTX could be physically entrapped into p-MTX micelles hydrophobic core region to increase the total drug loading. Importantly, the resulting MTX-loaded p-MTX micelles showed a biphasic release of MTX, with a relative fast release of the entrapped MTX (about 6-7h) followed by a sustained release of the conjugated MTX. The pharmacokinetics study showed that the mean residence time (MRT) was extended in the case of MTX-loaded p-MTX micelles, indicating a delayed MTX elimination from the bloodstream and prolonged in vivo residence time. Besides, the area under curve (AUC) of MTX-loaded p-MTX micelles was greater than free MTX, indicating a drug bioavailability improvement. Overall, MTX-loaded p-MTX micelles might be a promising nanosized drug delivery system for the cancer therapy.


PubMed | Jilin University and Siping Central Peoples Hospital
Type: Journal Article | Journal: Oncology letters | Year: 2016

Dumbbell-shaped hypoglossal Schwannomas of the 12th cranial nerve are extremely rare, and complete removal of these tumors is difficult, particularly in elderly patients with recurrent tumors. The present study reports the case of a 61-year-old male with a giant recurrent dumbbell-shaped hypoglossal schwannoma that arose extracranially. The recurrent tumor was completely removed in a one-stage surgical procedure via the far lateral suboccipital approach in combination with the transcervical approach. To the best of our knowledge, such a lesion has not been reported previously. The life expectancy and natural course of the disease are important factors to take into account when considering the individual end-point of surgery in patients. More studies on hypoglossal schwannomas are required, particularly cases in which the hypoglossal schwannoma was not totally resected, not only in order to develop more definitive and secure surgical treatments, but also to reduce the resultant unnecessary suffering of patients.

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