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Effect of Linagliptin on Glycemic Control in Chinese Patients with Newly-Diagnosed, Drug-Naïve Type 2 Diabetes Mellitus: A Randomized Controlled Trial.
Wu, W, Li, Y, Chen, X, Lin, D, Xiang, S, Shen, F, Gu, X
Medical science monitor : international medical journal of experimental and clinical research. 2015;:2678-84
Abstract
BACKGROUND This study aimed to evaluate the efficacy and safety of linagliptin (a novel dipeptidyl peptidase (DPP)-4 inhibitor) on glucose metabolism and β-cell function in Chinese patients with newly-diagnosed, drug-naïve type 2 diabetes mellitus (T2DM). MATERIAL AND METHODS Newly-diagnosed and drug-naïve T2DM patients were enrolled. After 4-week lifestyle modulation and 2-week placebo run-in, 57 patients were randomized to double-blind treatment with linagliptin (n=34) or placebo (n=23). The primary endpoint was the change from baseline in glycosylated hemoglobin A1c (HbA1c) after 24 weeks. Fasting plasma glucose (FPG), 2-h postprandial plasma glucose (2h-PPG), fasting insulin, proinsulin-to-insulin ratio, homeostasis model assessment of insulin resistance (HOMA-IR), and homeostasis model assessment of β-cell function (HOMA-β) were also evaluated. RESULTS Baseline characteristics were similar between the 2 groups. Compared with placebo, linagliptin therapy resulted in a significant decrease in HbA1C (-1.2±0.7% vs. -0.4±0.4%, P<0.001), FBG (-0.98±1.17 vs. -0.32±0.51 mmol/L, P=0.011, and 2h-PPG (-2.02±0.94 vs. -0.97±0.63 mmol/L, P<0.001). Significant differences were observed for the proinsulin/insulin ratio (P<0.001) and HOMA-β index (P=0.001). Rates of adverse events were similar between the 2 groups (30.3% vs. 27.3%). All adverse events were mild. One patient discontinued participation due to pregnancy. CONCLUSIONS Linagliptin treatment resulted in a significant and clinically meaningful improvement of glycemic control in drug-naïve Chinese patients with T2DM, as well as improved parameters of b-cell function. Linagliptin had an excellent safety profile.
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Chinese herbal medicine Tianqi reduces progression from impaired glucose tolerance to diabetes: a double-blind, randomized, placebo-controlled, multicenter trial.
Lian, F, Li, G, Chen, X, Wang, X, Piao, C, Wang, J, Hong, Y, Ba, Z, Wu, S, Zhou, X, et al
The Journal of clinical endocrinology and metabolism. 2014;(2):648-55
Abstract
CONTEXT Living in a prediabetes state significantly increases a patient's risk for both diabetes and cardiovascular disease. Tianqi capsule, containing 10 Chinese herbal medicines, is used in China for the treatment of type 2 diabetes mellitus (T2DM). OBJECTIVE The purpose of this study was to assess whether Tianqi prevented T2DM in subjects with impaired glucose tolerance (IGT) over the course of a 12-month treatment. METHODS Individuals with IGT were randomly allocated in a double-blind manner to receive Tianqi (n = 210) or a placebo (n = 210) for 12 months. Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance. All subjects received the same lifestyle education. The primary endpoint was the conversion of IGT to T2DM. Body weight and body mass index were observed. Adverse effects were monitored. RESULTS Of the 420 enrolled subjects with IGT, 389 completed the trial (198 in the Tianqi group and 191 in the placebo group). At the end of the 12-month trial, 36 subjects in the Tianqi group (18.18%) and 56 in the placebo group (29.32%) had developed diabetes (P = .01). There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups (n = 125, 63.13%, and n = 89, 46.60%, respectively; P = .001). Cox's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by 32.1% compared with the placebo. No severe adverse events occurred in the trial. There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the 12-month trial. CONCLUSIONS Treatment with a Tianqi capsule for 12 months significantly decreased the incidence of T2DM in subjects with IGT, and this herbal drug was safe to use.
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The efficacy of dapagliflozin combined with hypoglycaemic drugs in treating type 2 diabetes mellitus: meta-analysis of randomised controlled trials.
Sun, YN, Zhou, Y, Chen, X, Che, WS, Leung, SW
BMJ open. 2014;(4):e004619
Abstract
OBJECTIVES This meta-analysis aimed to evaluate whether dapagliflozin is synergistic with other antidiabetic drugs without body weight gain. SETTING Randomised controlled trial (RCT) reports were retrieved from PubMed, Cochrane Library, EMBASE, ClinicalTrials.gov, Google Scholar and Google. Eligible RCTs were selected according to the criteria (including types of participants, intervention, outcomes) and assessed by the Cochrane risk of bias tool and GRADEpro software for evidential quality. Meta-analysis on the eligible RCTs was performed with the random effects model. The RCTs of low-quality and interim stages were excluded for further sensitivity analysis. Meta-regression was conducted on the follow-up durations. Publication bias was evaluated with funnel plots and the Egger's regression test and adjusted using the trim-and-fill procedure. Heterogeneity was assessed with the I(2) statistics. PARTICIPANTS Adult patients with type 2 diabetes mellitus (T2DM). INTERVENTIONS Dapagliflozin combined with conventional antidiabetic drugs. PRIMARY AND SECONDARY OUTCOME MEASURES Glycaemic level (measured by glycosylated haemoglobin (HbA1c) and fasting plasma glucose (FPG)) and body weight. RESULTS 12 RCTs were eligible for quantitative synthesis and meta-analysis. The overall effect size of HbA1c calculated from mean difference was -0.52% (Z=-13.56, p<0.001) with 95% CI (-0.60 to -0.45). The effect size of FPG was -1.13 mmol/L (Z=-11.12, p<0.001) with 95% CI (-1.33 to -0.93). The effect size of body weight was -2.10 kg (Z=-18.77, p<0.001) with 95% CI (-2.32 to -1.88). Exclusions of low quality and interim RCTs changed the overall mean differences respectively to -0.56%, -1.11 mmol/L, 2.23 kg and -0.50%, -1.08 mmol/L, -2.08 kg. The sensitivity analysis indicated good robustness of the meta-analysis on HbA1c, FPG and body weight. CONCLUSIONS The meta-analysis showed that dapagliflozin as an add-on drug to conventional antidiabetic drugs improved the glycaemic control in T2DM participants without significant body weight gain. TRIAL REGISTRATION NUMBER CRD42013005034.
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The role of family history in clinical symptoms and therapeutic outcomes of women with polycystic ovary syndrome.
Hu, Z, Wang, Y, Qiao, J, Li, M, Chi, H, Chen, X
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2010;(1):35-9
Abstract
OBJECTIVE To investigate the association between family history and clinical symptoms of polycystic ovary syndrome (PCOS) that were thought to be inherited, by treating women with PCOS with contraceptive pills and metformin, and assessing outcomes. METHODS Of 164 women with PCOS, 49 with menstrual abnormalities, hyperandrogenism, and abnormal glucose and/or insulin levels underwent a 3-month treatment with contraceptive pills and metformin. Family history was taken, and physical and ultrasound examinations were performed. Serum levels of glucose, insulin, lipoproteins, lipids, and reproductive hormones were measured before and after treatment. RESULTS The serum levels of low-density lipoprotein, total cholesterol, apolipoprotein B, and triglycerides were higher in the patients with a family history of the studied symptoms than in those with no such family history. After treatment, changes in testosterone and glucose levels, glucose area under curve, and homeostasis model assessment value differed in the 2 groups. CONCLUSION The patients with a family history of PCOS symptoms thought to be inherited were more sensitive to oral contraceptive and metformin treatment.