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Clinical Trials

Date: 2012-06-11

Type of information:

phase: observational study

Announcement: results presented at the 72nd Annual Scientific Sessions of the ADA in Philadelphia

Company: Novo Nordisk (Denmark)

Product: Victoza® (liraglutide)

Action mechanism:

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 looked at data from 1,114 type 2 diabetes patients from primary care practices in the UK and assessed the clinical efficacy and patient preference with respect to liraglutide, exenatide and DPP-4 inhibitors.

Latest news:

Novo Nordisk has presend new data indicating that Victoza® (liraglutide [rDNA origin] injection) provided greater reductions in HbA1c compared to exenatide and DPP-4 inhibitors, with weight loss and cost-effectiveness, when used in routine primary care according to current UK type 2 diabetes treatment guidelines. The study presented at the 72nd Annual Scientific Sessions of the ADA in Philadelphia also shows that more patients appeared to favour a drug with a liraglutide-like profile, which is given by injection, over a drug with a sitagliptin-like profile, which is given orally.

Key findings from the study include:

• The results showed that greater reduction in HbA1c was seen in patients treated with liraglutide compared to exenatide or DPP-4 inhibitors (1.23% (±0.14), 0.79% (±0.19) and 0.72% (±0.23), p<0.05, n=1114).

•Significantly greater weight loss was seen in patients treated with liraglutide (n=256) compared to DPP-4 inhibitors (n=710) (-3.9 kg (±5.7) vs. -0.8 kg (±3.1), p<0.05) and greater weight loss was seen in patients treated with liraglutide (n=256) compared to exenatide (n=148) (-3.9 kg (±5.7) vs. -2.9 kg (±5.8)).

•More patients expressed a preference for a drug with a liraglutide-like profile over one with a sitagliptin-like profile (62.5% vs 37.5%, p<0.05).

•The calculated life years gained per patient was 0.12, 0.08 and 0.07 for those receiving liraglutide, exenatide or a DPP-4 inhibitor, respectively, compared to their respective baselines.

Based on observed treatment effects, the United Kingdom Prospective Diabetes Study (UKPDS) 68 risk equations were applied over a 20-year time horizon to calculate cost-effectiveness. The observed cost/QALY (Quality Adjusted Life Years) vs baseline for patients receiving liraglutide, exenatide or a DPP-4 inhibitor was £16,505, £16,648 and £20,661, respectively. Costs were calculated using the most commonly prescribed DPP-4 inhibitor, sitagliptin.

Is general: Yes