Date: 2015-06-06
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) in Bostonat the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Novo Nordisk (Denmark)
Product: Victoza® (liraglutide)
Action
mechanism: Glucagon-like Peptide 1 (GLP-1) analogue. Victoza® is a human glucagon-like peptide-1 (GLP-1) analogue that is 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta cells to release insulin and to suppress glucagon secretion from the alpha cells only when blood sugar levels are high. Due to this glucose-dependent mechanism of action, Victoza® is associated with a low rate of hypoglycaemia. The mechanism of blood sugar lowering also involves a delay in gastric emptying.
Disease: type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: The study was a 33-week, open-label, multinational clinical trial involving 343 people (172 for Victoza®, 171 for sulfonylurea). The study included people with type 2 diabetes with intent to fast during Ramadan, HbA1c 7-10%, BMI ≥20 kg/m2 , and treated with a stable dose of metformin and sulfonylurea (at maximum tolerated dose). Study participants were randomised to either switch to Victoza® (1.8 mg) or continue pre-trial sulfonylurea, both in combination with pre-trial metformin. Victoza® doses were escalated over 3 weeks, and followed by a 6- to 19-week treatment maintenance period preceding Ramadan. The primary endpoint was change in fructosamine from start to end of Ramadan (4-week period). Secondary endpoints included number of confirmed hypoglycaemic episodes during Ramadan as well as HbA1c reduction, HbA1c target <7% with no hypoglycaemic episodes and weight change at end of Ramadan from baseline.
Latest
news: * On June 6, 2015, Novo Nordisk announced that new findings showed that adults with type 2 diabetes treated with Victoza®, in combination with metformin, experienced similar improvements in blood glucose control while fasting during Ramadan (four weeks) compared with sulfonylurea (SU) plus metformin. People treated with Victoza® also demonstrated significantly better weight loss and fewer confirmed hypoglycaemic episodes compared with those treated with sulfonylurea during Ramadan. Findings from the LIRARamadan™ study were presented at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA) in Boston, MA. The 33-week, open-label, randomised study showed that Victoza® sustained blood glucose control during four weeks of Ramadan, with similar reductions in fructosamine levels compared with sulfonylurea (-12.8 µmol/L vs. -16.4 µmol/L; estimated treatment difference [ETD] 3.51 µmol/L [-5.26;12.28]; P=0.43).Testing fructosamine allows the effectiveness of diabetes treatment to be reliably evaluated after a couple of weeks. During Ramadan, patients treated with Victoza® experienced fewer confirmed hypoglycaemic episodes compared with people treated with sulfonylurea (2.0% vs. 4.3%), even though the Victoza® group had lower fructosamine concentration at the start of Ramadan. In addition, greater weight loss was observed in people treated with Victoza® during Ramadan vs. sulfonylurea (-1.43 kg/-3.1 lbs vs. -0.89 kg/-2.0 lbs; ETD - 0.54 kg/-1.2 lbs [-0.94/-2.07;-0.14/-0.31]; P=0.0091). In the LIRA-Ramadan™ study, people treated with Victoza® from baseline to the end of Ramadan were more likely to achieve an HbA1c target of <7% with no confirmed hypoglycaemic episodes compared with sulfonylurea (53.9% vs. 23.5%; OR 3.80 [2.24;6.46]; P<0.0001). Also, people treated with Victoza® compared with sulfonylurea experienced significantly greater weight loss (-5.40 kg/-11.9 lbs vs. -1.46 kg/-3.2 lbs; ETD -3.94 kg/-8.7 lbs [-4.54/-10.0;-3.33/-7.3]; P<0.0001), had significantly greater improvements in HbA1c (-1.24% vs. -0.65%; ETD -0.59% [-0.79;-0.38]; P<0.0001), were more likely to achieve the target level of HbA1c <7% (57.1% vs. 26.4%; OR 3.71 [2.18;6.30]; P<0.0001), and experienced significant reductions in fructosamine levels (- 39.6 µmol/L vs. -29.3 µmol/L; ETD -10.3 µmol/L [-18.7;-1.89]; P=0.0165). The percentage of patients experiencing adverse events (AEs) during Ramadan was similar in the Victoza® and sulfonylurea groups (23.7% vs. 20.9%), with gastrointestinal side effects more common with Victoza® treatment (10.5% vs. 3.7%).
