A Review of the Clinical Efficacy and Safety of Insulin Degludec and Glargine 300 U/mL in the Treatment of Diabetes Mellitus

2017 ◽  
Vol 39 (8) ◽  
pp. S12-S33 ◽  
Author(s):  
Vincent C. Woo
Medicine ◽  
2018 ◽  
Vol 97 (40) ◽  
pp. e12559 ◽  
Author(s):  
Xiao Li ◽  
Qi Zhao ◽  
Jingshang Wang ◽  
Jisheng Wang ◽  
Hengheng Dai ◽  
...  

2020 ◽  
Vol 8 (4) ◽  
pp. 47
Author(s):  
Api Chewcharat ◽  
Narut Prasitlumkum ◽  
Charat Thongprayoon ◽  
Tarun Bathini ◽  
Juan Medaura ◽  
...  

Background: The objective of this systematic review was to evaluate the efficacy and safety profiles of sodium-glucose co-transporter 2 (SGLT-2) inhibitors for treatment of diabetes mellitus (DM) among kidney transplant patients. Methods: We conducted electronic searches in Medline, Embase, Scopus, and Cochrane databases from inception through April 2020 to identify studies that investigated the efficacy and safety of SGLT-2 inhibitors in kidney transplant patients with DM. Study results were pooled and analyzed utilizing random-effects model. Results: Eight studies with 132 patients (baseline estimated glomerular filtration rate (eGFR) of 64.5 ± 19.9 mL/min/1.73 m2) treated with SGLT-2 inhibitors were included in our meta-analysis. SGLT-2 inhibitors demonstrated significantly lower hemoglobin A1c (HbA1c) (WMD = −0.56% [95%CI: −0.97, −0.16]; p = 0.007) and body weight (WMD = −2.16 kg [95%CI: −3.08, −1.24]; p < 0.001) at end of study compared to baseline level. There were no significant changes in eGFR, serum creatinine, urine protein creatinine ratio, and blood pressure. By subgroup analysis, empagliflozin demonstrated a significant reduction in body mass index (BMI) and body weight. Canagliflozin revealed a significant decrease in HbA1C and systolic blood pressure. In terms of safety profiles, fourteen patients had urinary tract infection. Only one had genital mycosis, one had acute kidney injury, and one had cellulitis. There were no reported cases of euglycemic ketoacidosis or acute rejection during the treatment. Conclusion: Among kidney transplant patients with excellent kidney function, SGLT-2 inhibitors for treatment of DM are effective in lowering HbA1C, reducing body weight, and preserving kidney function without reporting of serious adverse events, including euglycemic ketoacidosis and acute rejection.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A448-A449
Author(s):  
Juan Pablo Frias ◽  
Jenny Chien ◽  
Qianyi Zhang ◽  
Emmanuel Chigutsa ◽  
William Landschulz ◽  
...  

Abstract Basal insulin Fc (BIF; LY3209590) is a novel, once-weekly, long-acting IgG Fc-fusion protein that is being assessed for the treatment of diabetes mellitus. The presented study evaluated the safety and efficacy of BIF compared to insulin degludec over 32 weeks in patients with T2DM previously treated with oral antidiabetic drugs and a basal insulin. The study design included 2 different dosing algorithms for BIF (BIF-A1 and BIF-A2) with two different fasting glucose (FG) targets of ≤140 mg/dL (BIF-A1) and ≤120 mg/dL (BIF-A2). Insulin degludec was titrated to a FG target of ≤100mg/dL using a modified Riddle treat-to-target algorithm. Study participants (N=399) were randomized in a 1:1:1 ratio to 1 of 3 parallel treatment groups. The average age of participants was 60.2 years, baseline HbA1c was 8.1% and duration of diabetes 14.7 years. There were no statistically significant differences in demographics or baseline characteristics across the 3 treatment groups. Both BIF groups achieved non-inferiority (non-inferiority margin = 0.4%) for the primary endpoint of HbA1c change from baseline to Week 32 with a mean±SE reduction for BIF-A1, BIF-A2 and insulin degludec of 0.6±0.1%, 0.6±0.1% and 0.7±0.1%, respectively. In line with the different fasting serum glucose (FSG) targets, insulin degludec achieved greater FSG lowering from baseline as compared to the BIF arms. Similarly, both BIF dosing groups showed significantly fewer hypoglycemic events compared to insulin degludec (all documented events as well as nocturnal events) when assessing events ≤70 mg/dL (3.9 mmol/L). Hypoglycemic events &lt;54 mg/dL (3.0 mmol/L - all documented events as well as nocturnal events) were not significantly different between the three dosing groups. Two severe hypoglycemic events were reported in BIF-A2. The reported treatment-emergent adverse events and serious adverse events were balanced across the 3 treatment groups. Both BIF groups had a statistically significantly smaller increase in body weight compared to insulin degludec from baseline to Week 32. In summary, BIF, when administered weekly according to either dosing algorithm, was noninferior to insulin degludec for glycemic control as measured by change in HbA1c after 32 weeks with a lower rate of documented and nocturnal hypoglycemia ≤70 mg/dL and less weight gain. Additionally, no safety signals were detected. While higher FG targets were chosen in this first Phase 2 study with BIF, the safety and tolerability results allow assessment of lower target glucose ranges in future trials. The results from this study support continued development of BIF as a once-weekly insulin treatment of diabetes mellitus.


2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Sihan Peng ◽  
Ziyan Xie ◽  
Xiyu Zhang ◽  
Chunguang Xie ◽  
Jian Kang ◽  
...  

Background. Yuquan Pill (YQP), a Chinese patent medicine for the treatment of diabetes, is widely used in the treatment of diabetes and its complications in China. However, the efficacy of YQP on type 2 diabetes mellitus (T2DM) has not been completely assessed. The aim of this study is to evaluate the efficacy and safety of YQP in the treatment of T2DM. Materials and Methods. We systematically searched 9 databases for specific keywords from inception to Oct 2021. We included randomized controlled trials (RCTs) involving YQP in the treatment of T2DM without language limitation. The study conformed to the Cochrane Handbook and Review Manager software was used for data analysis. The weighted mean differences (WMDs) and 95% confidence intervals (CIs) were used to measure treatment effects. Results. The final analysis included 10 publications. Analysis showed that the combination of YQP and conventional treatment was more effective than conventional treatment alone with regard to the levels of fasting blood glucose (WMD = −0.83; 95% CI [−1.01,−0.66]; p < 0.00001 ), two-hour postprandial glucose (WMD = −1.40; 95% CI [−1.49,−1.31]; p < 0.00001 ), glycosylated hemoglobin (WMD = −0.87; 95% CI [−1.26, −0.49]; p < 0.00001 ), total cholesterol (WMD = −0.50; 95% CI [−0.61, −0.39]; p < 0.00001 ), c-reactive protein (WMD = −0.58; 95%CI [−0.88, −0.28]; p = 0.0002 ), and overall effective rate (RR = 1.21; 95% CI [1.12, 1.31]; p < 0.00001 ). Conclusion. Evidence suggested that YQP might improve glucose and lipid metabolism and inflammation in patients with T2DM. Serious adverse events were not reported. The quality of the evidence analyzed was low and therefore our results should be interpreted with caution. More high-quality RCTs are now needed to verify these findings.


2021 ◽  
Vol 12 ◽  
Author(s):  
Li-xin Guo ◽  
Guo-en Liu ◽  
Li Chen ◽  
Hai-fang Wang ◽  
Jian Guo ◽  
...  

ObjectivesThis study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).MethodsThis randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.ResultsThere were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p&gt;0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.ConclusionsMetformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.


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