期刊
DIABETES OBESITY & METABOLISM
卷 23, 期 7, 页码 1594-1603出版社
WILEY
DOI: 10.1111/dom.14373
关键词
dyslipidaemia; GLP-1 analogue; glycaemic control; incretin therapy; pharmacodynamics; type 2 diabetes
资金
- Novo Nordisk A/S, Soborg, Denmark
Oral semaglutide significantly improved both fasting and postprandial glucose and lipid metabolism, and delayed gastric emptying in subjects with type 2 diabetes. However, one serious adverse event (acute myocardial infarction) did occur during the treatment.
Aim: To assess the effects of oral semaglutide on postprandial glucose and lipid metabolism, and gastric emptying, in subjects with type 2 diabetes (T2D). Materials and Methods: In this randomized, double-blind, single-centre, crossover trial, subjects with T2D received once-daily oral semaglutide (escalated to 14 mg) followed by placebo, or vice versa, over two consecutive 12-week periods. Glucose and lipid metabolism, and gastric emptying (paracetamol absorption) were assessed before and after two types of standardized meals (standard and/or fat-rich) at the end of each treatment period. The primary endpoint was area under the glucose 0-5-h curve (AUC(0-5h)) after the standard breakfast. Results: Fifteen subjects were enrolled (mean age 58.2 years, HbA1c 6.9%, body weight 93.9 kg, diabetes duration 3.1 years; 13 [86.7%] males). Fasting concentrations of glucose were significantly lower, and C-peptide significantly greater, with oral semaglutide versus placebo. Postprandial glucose (AUC(0-5h)) was significantly lower with oral semaglutide versus placebo (estimated treatment ratio, 0.71; 95% CI, 0.63, 0.81; p < .0001); glucose incremental AUC (iAUC(0-5h/5h)) and glucagon AUC(0-5h) were also significantly reduced, with similar results after the fat-rich breakfast. Fasting concentrations of triglycerides, very low-density lipoprotein (VLDL) and apolipoprotein B48 (ApoB48) were significantly lower with oral semaglutide versus placebo. AUC(0-8h) for triglycerides, VLDL and ApoB48, and triglycerides iAUC(0-8h/8h), were significantly reduced after oral semaglutide versus placebo. During the first postprandial hour, gastric emptying was delayed (a 31% decrease in paracetamol AUC(0-1h)) with oral semaglutide versus placebo. One serious adverse event (acute myocardial infarction) occurred during oral semaglutide treatment. Conclusion: Oral semaglutide significantly improved fasting and postprandial glucose and lipid metabolism, and delayed gastric emptying.
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