Furthermore, the initiation of bolus insulin was permitted after the 5-week period and only after optimization of basal insulin dose. Basal insulin dose was not to exceed the entry dose within the first 5 weeks. In individuals using twice-daily basal insulins, adjustment was based on the mean of three prebreakfast and predinner SMBG measurements. In individuals using once-daily basal insulins, weekly adjustments were based on the mean of three prebreakfast SMBG values with a target range of 4 to 5 mmol/L (71–90 mg/dL). Insulin doses were adjusted based on self-measured BG (SMBG) values to ensure that similar levels of fasting glucose were maintained between the two arms, regardless of background medication ( Supplementary Table 1).
In individuals with HbA 1c ≤8% (64 mmol/mol) at randomization, it was recommended to reduce the dose of basal insulin by 15–20% owing to anticipated glycemic improvements. It was recommended that, after randomization and at the investigator’s discretion, individuals should reduce their dose of SUs by 50% to lower the likelihood of SU-induced hypoglycemia. Furthermore, to our knowledge, no medications approved for chronic weight management have been prospectively investigated in individuals with overweight or obesity and insulin-treated type 2 diabetes. While liraglutide 1.8 mg is indicated in combination with insulin for diabetes treatment, liraglutide 3.0 mg combined with insulin for weight management has not previously been studied. In this previous study, weight loss of 4.7% and 6.0% was observed with liraglutide 1.8 mg and 3.0 mg, respectively, versus 2.0% with placebo ( 19).
#Aweeraser 3.0 trial trial#
SCALE Diabetes was a 56-week trial of liraglutide 1.8 mg and 3.0 mg in individuals with overweight or obesity and diabetes treated with ≤2 oral antidiabetic drugs (OADs) but excluded insulin-treated individuals. Liraglutide 3.0 mg ( 18) is approved for chronic weight management in individuals with overweight or obesity and has been investigated in individuals with type 2 diabetes as part of the Satiety and Clinical Adiposity-Liraglutide Evidence (SCALE) phase 3a program.
It is also approved as a fixed-ratio combination with insulin degludec ( 17), as an adjunct to diet and exercise for type 2 diabetes treatment. Liraglutide is an analog of GLP-1 and in doses up to 1.8 mg is approved for use in combination with insulin ( 16).
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