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01 Jun 2015
New drug applications approved by US FDA as of 15 – 31 May 2015 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
22 May 2017
Consumption of glutinous brown rice (GBR) controls the whole-day glucose profile of patients with type 2 diabetes mellitus (T2DM), mainly by lowering postprandial glucose excursion, reports a study. In addition, GBR is preferred over nonglutinous brown rice (BR) in terms of palatability.
10 Oct 2016
Use of dipeptidyl peptidase-4 (DPP-4) inhibitors may reduce the risk of mortality and the combination of myocardial infarction and ischaemic stroke in type 2 diabetes (T2D), without increasing the risk of hospitalisation for heart failure even in T2D patients with pre-existing HF, a nationwide cohort study from Taiwan suggests.

DS-8500a improves glycaemic, lipid variables in T2D

Audrey Abella
26 Sep 2017

The novel, G-protein coupled receptor 119 (GPR119) agonist DS-8500a demonstrated dose-dependent glucose-lowering effects and favourable improvements in lipid parameters that extended up to 12 weeks in Japanese patients with type 2 diabetes mellitus (T2D), according to data presented at EASD 2017.

This multicentre, double-blind trial comprised 368 patients with T2D and HbA1c levels between ≥7 and <10 percent. Participants were randomized 1:1:1 to receive once-daily administration of DS-8500a (either 25 mg, 50 mg, or 75 mg), sitagliptin 50 mg, or placebo for 12 weeks. [EASD 2017, abstract 847]

At week 12, a dose-dependent reduction in HbA1c levels was observed among patients on DS-8500a compared with placebo (-0.21 percent; p=0.0233 for 25 mg, -0.34 percent; p=0.0004 for 50 mg, and -0.45 percent; p<0.0001 for 75 mg).

Compared with placebo, DS-8500a 50 mg and 75 mg also reduced fasting plasma glucose (FPG, -12.7 mg/dL; p=0.0004 and -14.4 mg/dL; p<0.0001, respectively), area under the curve0-3h for glucose during a meal tolerance test (-50.6 mg/dL x h; p=0.0020 and -59.7 mg/dL x h; p=0.0003), and 2-hour postprandial glucose (-18.5 mg/dL; p=0.0102 and -22.0 mg/dL; p=0.0022).

FPG reduction was sustained for up to 12 weeks, said the researchers, which is an improvement from other GPR119 agonists that typically have shorter glucose-lowering effects lasting for up to 2–4 weeks only.

With regards to lipid profile, administration of DS-8500a 50 mg and 75 mg resulted in a significant increase in HDL cholesterol vs placebo (5.9 percent; p=0.0032 and 6.6 percent; p=0.0009, respectively), as well as a significant reduction in total cholesterol (-7.0 percent; p<0.0001 and -6.2 percent; p=0.0002), LDL cholesterol (-7.3 percent; p=0.0044 and -8.1 percent; p=0.0014), and triglycerides (-32.7 percent; p<0.0001 and -30.9 percent; p<0.0001).

Apart from two cases of clinically-relevant drug-related hypoglycaemia in the DS-8500a 50 mg arm, DS-8500a was generally well tolerated with no reports of serious drug-related treatment-emergent adverse events at any dose of DS-8500a.

These results were consistent with the findings of a previous study in another Japanese cohort, [Diabetes 2016;65:abstract 119-LB] providing additional data showing the potential benefit of DS-8500a for T2D, noted the researchers.

 

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Most Read Articles
01 Jun 2015
New drug applications approved by US FDA as of 15 – 31 May 2015 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
22 May 2017
Consumption of glutinous brown rice (GBR) controls the whole-day glucose profile of patients with type 2 diabetes mellitus (T2DM), mainly by lowering postprandial glucose excursion, reports a study. In addition, GBR is preferred over nonglutinous brown rice (BR) in terms of palatability.
10 Oct 2016
Use of dipeptidyl peptidase-4 (DPP-4) inhibitors may reduce the risk of mortality and the combination of myocardial infarction and ischaemic stroke in type 2 diabetes (T2D), without increasing the risk of hospitalisation for heart failure even in T2D patients with pre-existing HF, a nationwide cohort study from Taiwan suggests.