02.04.2016 – 19:18
Victoza® (liraglutide 1.8 mg) Provided Superior HbA1c Reductions in Adults with Type 2 Diabetes Compared to Continued Sitagliptin Treatment
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Findings from a clinical trial comparing Victoza® (liraglutide 1.8 mg) and sitagliptin (100 mg), both in combination with metformin, demonstrated that switching from sitagliptin to Victoza® provided superior HbA1c reductions vs continuing with sitagliptin treatment in adults with type 2 diabetes. Results from the LIRA-SWITCH trial were presented at the Endocrine Society's 98th Annual Meeting and Expo (ENDO 2016) in Boston, MA, US.
The 26-week LIRA-SWITCH trial assessed the efficacy and safety of Victoza® as an add-on to metformin in 407 adults with type 2 diabetes who switched from sitagliptin. Of the 407 adults uncontrolled on sitagliptin (HbA1c 7.5-9.5%) at week 26, those who switched to Victoza® (n=203) achieved a superior reduction in HbA1c vs those who continued their sitagliptin treatment (n=204) (?1.14% vs ?0.54%; estimated treatment difference [ETD] ?0.61%, 95% confidence interval [CI]: ?0.82 to ?0.40, p<0.0001).
Additionally, adults who switched to Victoza® experienced significantly greater body weight reductions vs those who continued with their sitagliptin dose (?3.31 kg/?7.29 lb vs ?1.64 kg/?3.62 lb; ETD ?1.67 kg/?3.68 lb, 95% CI: ?2.34 to ?0.99, p<0.0001).
"The LIRA-SWITCH trial results provide valuable insight that adults uncontrolled on sitagliptin may achieve a superior HbA1c reduction with liraglutide 1.8 mg vs continuing on sitagliptin treatment," said Dr Maximo Maislos, Director of Western Negev Mobile Diabetes Clinic Program, and Diabetes and Metabolism, Ben-Gurion University FOHS, Beer Sheva-Israel and investigator of the LIRA-SWITCH trial. "These findings are valuable as there is limited clinical evidence to guide treatment strategy when people with type 2 diabetes are uncontrolled on second-line therapy."
The trial demonstrated that more adults with type 2 diabetes treated with Victoza® vs sitagliptin achieved HbA1c targets <7% (50.6% vs 26.9%; OR [odds ratio]: 3.36; 95% CI: 2.08 to 5.42, p<0.0001) and <=6.5% (29.5% vs 9.9%; OR: 5.44; 95% CI: 2.82 to 10.47, p<0.0001). Furthermore, adults treated with Victoza® demonstrated significantly greater reductions in fasting plasma glucose vs those treated with sitagliptin (?1.84 vs ?0.73; ETD: ?1.10; 95% CI ?1.50 to ?0.71, p<0.0001).,
Adverse events were more common in the Victoza® group vs the sitagliptin group (68.8% vs 56.9%), with gastrointestinal side effects more frequent with Victoza®: nausea (21.8% vs 7.8%) and diarrhoea (16.3% vs 9.3%). There were no reports of severe hypoglycaemia and no reports of confirmed nocturnal hypoglycaemia.
About the LIRA-SWITCH Trial
The 26-week trial was a randomised, double-blind, double-dummy, active-controlled trial involving 407 adults with type 2 diabetes not achieving adequate glycaemic control on sitagliptin as add-on to metformin. Trial participants were previously treated with stable doses of sitagliptin (100 mg daily) and metformin (>=1500 mg daily or maximum tolerated dose >=1000 mg daily) for >=90 days. Participants were randomised 1:1 to switch to Victoza® 1.8 mg or continue sitagliptin 100 mg, both in combination with metformin.
Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analogue with an amino acid sequence 97% similar to endogenous human GLP-1. Like natural GLP-1, Victoza® works by stimulating the beta-cells to release insulin and suppressing 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.* In addition, liraglutide reduces body weight and body fat mass through mechanisms involving reduced appetite and lowered energy intake.
Victoza® was launched in the EU in 2009 and is commercially available in more than 80 countries, treating more than 1 million people with type 2 diabetes globally., In Europe, Victoza® is indicated for the treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. In the US, Victoza® was approved in 2010 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.
*Hypoglycaemia has primarily been observed when Victoza® is combined with a sulfonylurea or basal insulin.
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1. Bailey T, Takács R, Tinahones F, et al. Efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes: a randomized, double-blind, double-dummy, active-controlled 26-week trial. Abstract number 689-P. Endocrine Society's 98th Annual Meeting and Expo (ENDO 2016), Boston, MA, US; 1-4 April 2016. 2. Data on file. Novo Nordisk. NCT01907854. 3. EMA. Victoza® EU Summary of Product Characteristics. November 2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_l ibrary/EPAR_-_Product_Information/human/001026/WC500050017.pdf Lastaccessed 29.03.2016. 4. Internal Calculations based on IMS Midas Quantum data. September 2015. 5. FDA. Victoza® US prescribing information. Available at: http://www .accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf. Last accessed 29.03.2016.
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