-
1.
Phase III, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of teneligliptin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.
Ji, L, Ma, J, Lu, W, Liu, J, Zeng, J, Yang, J, Li, W, Zhang, X, Xiao, X, Takayanagi, G, et al
Journal of diabetes investigation. 2021;(4):537-545
Abstract
AIMS/INTRODUCTION Although the efficacy of teneligliptin, a highly selective dipeptidyl peptidase-4 inhibitor, has been amply studied for the treatment of type 2 diabetes, no clinical trials of teneligliptin have been carried out in China. We evaluated the efficacy and safety of teneligliptin monotherapy compared with a placebo in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. MATERIALS AND METHODS This multicenter, randomized, double-blind, placebo-controlled, parallel-group study, carried out at 42 sites, enrolled type 2 diabetes patients with glycosylated hemoglobin 7.0 to <10.0% and fasting blood glucose <270 mg/dL. Patients were randomly assigned, in a 1:1 ratio, to treatment with 20 mg teneligliptin or a placebo (n = 127, each) administered orally once daily before breakfast for 24 weeks. Change in glycosylated hemoglobin from baseline to week 24 was the primary efficacy end-point. Safety was assessed by the incidence of adverse events and adverse drug reactions. RESULTS The least square mean (LSM) change in glycosylated hemoglobin from baseline to week 24 was -0.95% with teneligliptin versus -0.14% with a placebo, yielding an LSM difference (teneligliptin vs placebo) of -0.80% (P < 0.0001). For the secondary end-point, from baseline to week 24, the LSM change in fasting blood glucose was -21.9 mg/dL with teneligliptin versus -1.4 mg/dL with a placebo, yielding an LSM difference (teneligliptin vs placebo) of -20.5 mg/dL (P < 0.0001). The adverse event and adverse drug reaction incidence rates, including hypoglycemia, were similar in both groups. CONCLUSIONS At 24 weeks, teneligliptin was generally well tolerated and effective in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.
-
2.
Self-management among type 2 diabetes patients via the WeChat application: A systematic review and meta-analysis.
Yang, J, Yang, H, Wang, Z, Wang, X, Wang, Y, Yu, X, Liu, L
Journal of clinical pharmacy and therapeutics. 2021;(1):4-16
Abstract
WHAT IS KNOWN AND OBJECTIVE The incidence of diabetes has been rising worldwide and is expected to increase to affect 591.9 million people by 2035 in China. Strict control of blood glucose can significantly reduce the risk of diabetic complications, but traditional interventions lack continuity, timeliness and teleonomy. The development of mobile health management has become a hot topic, as a very popular app in China, WeChat platform, has a large number of users every day. Many studies show the health management of patients with diabetes through WeChat can achieve the ideal effect. This study aims to evaluate the application of WeChat based on clinical research data, provide clinical evidence for medical staff and promote the self-management of patients with diabetes. METHODS The PubMed, EMBASE, Cochrane Library, CNKI and Wanfang database were searched to identify related reports that were published up to 9 March 2020. The quality of included studies was assessed by Cochrane Collaboration risk assessment tool. Measures of interest were mean difference (MD) and 95% confidence interval (CI). Random-effect model was used according to the absence or presence of significant heterogeneity. Heterogeneity among trials was evaluated by I2 test. Publication bias was assessed by funnel plots. RESULTS AND DISCUSSION Thirty-eight articles involved 2,709 controls and 2,709 patients who used WeChat were identified. Relative to the traditional group, WeChat group had a lower level in fasting plasma glucose (FPG in mmol/L; MD: 1.36, 95% CI 1.10-1.62, P < .00001), so did 2hPG (MD: 1.91, 95% CI 1.48-2.35, P < .00001) and HbA1C (MD: 1.07, 95% CI 0.86-1.27, P < .00001). Self-efficacy scale improved significantly, including diet score (MD: -1.31, 95% CI -1.77 to -0.86, P < .00001), exercise score (MD: -1.92, 95% CI -2.44 to -1.40, P < .00001), medication taking score (MD: -1.45, 95% CI: -1.94 to -0.97, P < .00001), monitoring of blood glucose score (MD: -1.17, 95% CI -1.83--0.51, P = .0005) and foot care score (MD: -1.71, 95% CI -2.08 to -1.34, P < .00001). Patients' understanding of the disease and satisfaction with follow-up increased significantly, whereas the incidence of adverse reactions and complications decreased. WHAT IS NEW AND CONCLUSION WeChat follow-up appears to be helpful to improve the level of blood glucose and self-management, reduce the incidence of adverse reactions and complications, and improve the satisfaction rate of patients with type 2 diabetes. It should be noted that this meta-analysis has limitations, such as small sample sizes and the low quality of included literature, as well as the lack of research in Western countries. Therefore, more high-quality studies with larger samples are needed in the future to verify our results.
-
3.
Ipragliflozin as an add-on therapy in type 2 diabetes mellitus patients: An evidence-based pharmacoeconomics evaluation.
Wang, H, Yao, G, Chen, X, Ouyang, J, Yang, J
Diabetes research and clinical practice. 2019;:107867
Abstract
AIM: To evaluate the efficacy, safety and cost-effectiveness of ipragliflozin as an add-on therapy in patients with type 2 diabetes mellitus (T2DM). METHODS PubMed, EMBASE, the Cochrane Library, Web of Science and four Chinese databases, as well as the ClinicalTrials.gov website were searched from their inception through Jan 2019. Methodological quality was assessed using the Cochrane risk of bias, and meta-analysis was performed using RevMan5.3. RESULTS A total of 11 randomized controlled trials with 1766 patients were included. Ipragliflozin administered (50 mg) once daily as an add-on therapy to other glucose-lowering medications (metformin, pioglitazone, sulfonylurea, α-glucosidase inhibitor, sitagliptin, insulin) was associated with reductions in hemoglobin A1c (HbA1c) of -0.74% (95% confidence interval (CI) -1.00 to -0.48), fasting plasma glucose (WMD -25.03 mg/dL; 95% CI -32.89 to -17.16), weight, waist circumference, blood pressure, and triglycerides levels. Neither the incidence of treatment-emergent adverse events (TEAEs) (RR 1.08; 95% CI 1.00 to 1.16) nor drug-related TEAEs (RR 1.19; 95% CI 0.93 to 1.54) was significantly increased. However, it was associated with an increased risk of hypoglycemia when added to insulin (RR 1.71; 95% CI 1.13 to 2.61). Compared with the pioglitazone group and the sitagliptin + metformin group, the incremental cost-effectiveness ratio of ipragliflozin add-on therapy group was $4976.89, $2089.76 per percentage of qualified HbA1c, respectively. CONCLUSION Ipragliflozin as an add-on therapy is well tolerated and effective. Ipragliflozin as an add-on therapy do not appear cost-effective compared with metformin alone, but may be competitive against pioglitazone group and the sitagliptin + metformin group.
-
4.
Effects of Sodium-glucose Cotransporter 2 Inhibitor Monotherapy on Weight Changes in Patients With Type 2 Diabetes Mellitus: a Bayesian Network Meta-analysis.
Wang, H, Yang, J, Chen, X, Qiu, F, Li, J
Clinical therapeutics. 2019;(2):322-334.e11
Abstract
PURPOSE The aim of this study was to systematically evaluate the effect of sodium-glucose cotransporter 2 (SGLT2) inhibitor monotherapy on the weight of patients with type 2 diabetes mellitus (T2DM) and to compare different SGLT2 inhibitors with other oral glucose-lowering medications. METHODS PubMed, EMBASE, Cochrane Library, and the ClinicalTrials.gov Web site were searched for relevant randomized controlled trials. Patients with T2DM in the included studies were administered SGLT2 inhibitor monotherapy for at least 12 weeks. The primary outcome was the change in weight from baseline; the secondary outcome was the proportion of patients achieving a weight reduction ≥5%. A pairwise meta-analysis using the DerSimonian-Laird random effects model and a network meta-analysis with Bayesian Markov chain Monte Carlo random effects models were performed. FINDINGS A total of 29 randomized controlled trials (11,999 patients) with a low risk of bias were identified. The results showed that the mean weight loss ranged from -2.26 kg (95% credible interval [CrI], -2.71 to -1.76) with canagliflozin 300 mg to -0.79 kg (95% CrI, -1.54 to -0.05) with ipragliflozin 25 mg compared with metformin. Compared with linagliptin and sitagliptin, the mean weight loss ranged from -3.17 kg (95% CrI, -3.67 to -2.57) with canagliflozin 300 mg to -0.93 kg (95% CrI, -1.92 to 0.05) with ipragliflozin 25 mg. Canagliflozin 300 mg reduced weight to a greater extent than the other SGLT2 inhibitors, with a probability of 99.44%. SGLT2 inhibitors also improved the proportions of patients achieving ≥5% weight loss. The effect of SGLT2 inhibitors on weight reduction was associated with dosage. IMPLICATIONS Available evidence from randomized controlled trials suggests that SGLT2 inhibitor monotherapy exerts more beneficial effects on weight reduction than both metformin and dipeptidyl peptidase 4 inhibitors. The weight reduction effect of 300 mg canagliflozin is greater than that of most other SGLT2 inhibitors. More types of SGLT2 inhibitors in a head-to-head trial, as well as a comparison between SGLT2 inhibitors and glucagon-like peptide 1 receptor agonists, will be involved in our further research. International Prospective Register of Systematic Reviews: CRD42018089761.
-
5.
The cardiovascular effect of incretin-based therapies among type 2 diabetes: a systematic review and network meta-analysis.
Wu, S, Cipriani, A, Yang, Z, Yang, J, Cai, T, Xu, Y, Quan, X, Zhang, Y, Chai, S, Sun, F, et al
Expert opinion on drug safety. 2018;(3):243-249
Abstract
OBJECTIVE To evaluate the comparative cardiovascular safety of incretin-based therapies in patients with type 2 diabetes mellitus (T2DM). METHODS Medline, Embase, the Cochrane Library and www.clinicaltrials.gov were searched for randomized controlled trials (RCTs) with duration≥12 weeks. Network meta-analysis was performed, followed by subgroup analysis and meta-regression. The Grading of Recommendations Assessment, Development and Evaluation system was used to assess the quality of evidence. The outcome of interest was a composite of cardiovascular death, myocardial infarction, stroke and heart failure. Odds ratio (OR) with 95% confidence interval (CI) was calculated as the measure of effect size. RESULTS 281 RCTs (76.9% double-blinded) with 180,000 patients were included, comparing incretin-based therapies with other six classes of anti-diabetic drugs or placebo. A statistically significant reduction in the risk of cardiovascular events was found in favour of GLP-1RAs when compared with placebo (OR 0.89, 95%CI: 0.80-0.99) and sulfonylurea (OR 0.76, 95%CI: 0.59-0.99), whereas DPP-4 inhibitors showed a neutral effect compared with placebo (OR 0.92, 95%CI: 0.83-1.01). CONCLUSIONS Incretin-based therapies show similar cardiovascular risk in comparison with metformin, insulin, thiazolidinediones, alpha-glucosidase inhibitor and sodium-glucose co-transporter 2. GLP-1RA could decrease the risk compared with sulfonylurea or placebo, while DPP-4I appears to have neutral effect on cardiovascular risk.
-
6.
Ertugliflozin for treatment of patients with Type 2 diabetes mellitus.
Yang, J
Expert review of clinical pharmacology. 2018;(8):747-753
Abstract
Type 2 diabetes mellitus (T2DM) is a growing and serious global health problem. Inhibition of the sodium--glucosecotransporter-2 (SGLT2) can increase urinary glucose excretion and decrease plasma glucose levels in an insulin-independent manner. Ertugliflozin is a highly selective inhibitor of SGLT2, and was approved in the US for the treatment of adults with T2DM. Areas covered: In this paper, the mechanism of action, pharmacokinetics, clinical efficacy, safety, etc., of ertugliflozin have been introduced. Expert commentary: Ertugliflozin offers a novel, therapeutic approach to T2DM. Advantages of ertugliflozin include reduction in glycated hemoglobin, weight loss and blood pressure lowering with a low risk of hypoglycemia. The main adverse effects likely to be seen are genital fungal infections. Studies show that there is no increased risk of cardiovascular disease, but studies focusing on longer duration outcome are still essential.
-
7.
Association of Bone Metabolic Markers With Diabetic Retinopathy and Diabetic Macular Edema in Elderly Chinese Individuals With Type 2 Diabetes Mellitus.
Zhang, X, Yang, J, Zhong, Y, Xu, L, Wang, O, Huang, P, Li, C, Qu, B, Wang, J, Zheng, C, et al
The American journal of the medical sciences. 2017;(4):355-361
-
-
Free full text
-
Abstract
BACKGROUND Diabetic retinopathy (DR) is a common and specific microvascular complication of diabetes. The association of bone metabolic markers with the risk of DR and diabetic macular edema (DME) is unclear. MATERIALS AND METHODS We investigated the association between bone turnover markers commonly examined in a clinical setting and DR and DME risk in elderly Chinese patients with type 2 diabetes mellitus (T2DM). A total of 408 patients aged 55-70 years with T2DM were included. We first performed univariable logistic regression followed by multivariable logistic regression that included variables selected using purposeful selection. RESULTS Fasting blood glucose (P = 0.007) and duration of diabetes (P < 0.0001) were significantly associated with DME in multivariable logistic regression; however, the association of beta C-terminal telopeptide of collagen type I (β-CTx) with DME risk was not statistically significant (P = 0.053). Sex-stratified analysis showed that β-CTx was significantly associated with DME only in female subjects (P = 0.011). CONCLUSIONS β-CTx had no significant association with DR. It was significantly associated with DME in female patients with T2DM, but not in male patients with T2DM. More prospective studies with larger sample sizes are warranted to validate our findings.