The Lancet Publishes New Data Demonstrating Significantly Improved Efficacy Of Victoza(R) Compared T…
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The Lancet promulgated on-line the results of the kickoff cogitation comparison the once-daily hum GLP-1 linear liraglutide with the DPP-4, inhibitor sitagliptin. The 26-week run showed that discussion with liraglutide (1.2mg or 1.8mg) once-daily in combining with glucophage resulted in importantly greater reductions in HbA1c and fast plasm glucose (FPG) compared with discussion with once-daily sitagliptin (100mg) in combining with glucophage.1 Additionally, importantly greater reductions in torso weighting were discovered with liraglutide (1.2mg or 1.8mg) once-daily in compounding with glucophage compared to once-daily sitagliptin (100mg) in compounding with glucophage.1 Overall intervention expiation in a subgroup of patients was interchangeable with 1.2mg liraglutide compared with sitagliptin and amend with 1.8mg liraglutide compared with sitagliptin.1
Furthermore, importantly more patients hardened with liraglutide achieved the National Institute of Clinical Health and Excellence (NICE) HbA1c targets for typecast 2 diabetes of 6.5%,2 compared with those toughened with sitagliptin.1 Nearly double as many sketch participants on liraglutide reached the NICE destination compared to the sitagliptin radical (35.8% and 22.6% severally in the 1.8mg and 1.2mg liraglutide groups versus 11.9% in the sitagliptin aggroup).3
“This is selfsame authoritative new information for healthcare professionals (HCPs) look later masses with diabetes. This low ‘psyche to brain’ run ‘tween a commissioned unwritten DPP-4 inhibitor (sitagliptin) and an injectable homo GLP-1 linear (liraglutide) has shown improved handling atonement with the injectable therapy (1.8 mg liraglutide),” aforesaid lede researcher Professor Melanie Davies, Professor of Diabetes Medicine, University of Leicester and Honorary Consultant, University Hospitals of Leicester. “This challenges the really cornerstone of the opposition that around HCPs let to the use of injectable therapies and hopefully volition cause more proactive direction of patients with eccentric 2 diabetes.”
The discipline was a 26-week, randomized, parallel-group, open-label tribulation comparison prophylactic and efficaciousness of the two sanctioned alimony doses of once-daily liraglutide (1.2mg and 1.8mg) with once-daily sitagliptin (100mg) both added to glucophage. It was conducted in Europe and North America in 665 masses with character 2 diabetes who were not adequately controlled on day-to-day intervention with ?1500mg glucophage lone.
Major findings from the sketch admit:
- Liraglutide provided improved reductions in HbA1c versus sitagliptin (1.50% and 1.24% severally for liraglutide 1.8mg and 1.2mg, 0.90% for sitagliptin).1
- Mean decreases in FPG were importantly greater with liraglutide (2.14mmol/L [38.5mg/dL] and 1.87mmol/L [33.7mg/dL] severally for liraglutide 1.8mg and 1.2mg, 0.83mmol/L [15mg/dL] for sitagliptin).1
- Liraglutide resulted in importantly greater reductions in soundbox weighting (3.38kg and 2.86kg severally for liraglutide 1.8mg and 1.2mg, 0.96kg for sitagliptin).1
Secondary endpoints included the Diabetes Treatment Satisfaction Questionnaire (DTSQ), a validated quantity victimized in many diabetes trials to step the modification in discourse gratification. Improvement in boilersuit handling atonement in a subgroup of patients was importantly greater with liraglutide 1.8mg than sitagliptin, and standardised betwixt liraglutide 1.2mg and sitagliptin.1 No boilersuit differences in the sensed gadget of intervention (viva vs injectant) were reported.1
Both liraglutide and sitagliptin were fountainhead tolerated. Minor hypoglycemia was recorded in roughly 5% of participants in apiece handling grouping and one patient on 1.2mg liraglutide had a major hypoglycemic instalment (lineage glucose compactness of 3•6 mmol/L).1 Nausea initially occurred at higher rates with liraglutide 1.8mg (27%) and 1.2mg (21%) than sitagliptin (5%). However, sickness with liraglutide was transitory - virtually episodes occurred former with few withdrawals (n = 52, 27 and 25 for the liraglutide 1.2mg, liraglutide 1.8mg and sitagliptin 100mg discussion groups severally).1 By the end of the test, the preponderance of sickness with liraglutide was alike to that with sitagliptin.1
Liraglutide and sitagliptin are both incretin-based diabetes therapies. Liraglutide is a once-daily buzz GLP-1 parallel that mimics the action of the naturally-occurring endocrine GLP-1. Sitagliptin is a DPP-4 inhibitor that blocks the enzyme creditworthy for the dislocation of GLP-1 and over-the-counter substances.4
The American Diabetes Association, the European Association for the Study of Diabetes, the American Association of Clinical Endocrinologists, and the American College of Endocrinology consensus statements recognize GLP-1 analogues and DPP-4 inhibitors as good supplement intervention for patients who are not responding to glucophage and life-style changes unparalleled.5,6
Liraglutide is indicated for handling of adults with character 2 diabetes to attain glycaemic command: in combining with glucophage or a sulphonylurea, in patients with deficient glycaemic ascendence contempt maximum tolerated acid of monotherapy with glucophage or sulphonylurea; in compounding with glucophage and a sulphonylurea or glucophage and a thiazolidinedione in patients with deficient glycaemic ascendance contempt double therapy.7
Liraglutide is a once-daily hum Glucagon-like peptide-1 (GLP-1) linear for the discussion of eccentric 2 diabetes.7 Liraglutide lowers descent glucose levels by exhilarating the firing of insulin but when glucose levels go too mellow.7 It too inhibits appetency.7
The liraglutide stage 3 clinical visitation broadcast, entitled LEADTM is comprised of randomized studies comparison liraglutide to usually ordained treatments. These transnational trials evaluated liraglutide in compounding with one or two viva antidiabetic medications and showed bettor or tantamount threatening of line glucose than alive comparators including rosiglitazone, glimepiride, insulin glargine and exenatide.8-11
Furthermore, in improver to its glucose heavy effects, liraglutide is broadly not associated with slant gather. For nigh patients with eccentric 2 diabetes, clinical test information certify a simplification in trunk weightiness (betwixt 1 and 2.8kg) in the LEAD™ broadcast.7 Body burthen was a lower-ranking termination in the clinical growing trials.7-12
The nearly park contrary events reported during the clinical evolution plan in patients hardened with liraglutide were associated with the gi organization. Gastrointestinal contrary events, including sickness, disgorgement and diarrhea were reported about oft. The about shop untoward reactions stellar to secession for liraglutide-treated patients were sickness (2.8% of patients) and regurgitation (1.5%). However, these reactions unremarkably fall inside a few years or weeks on continued discussion.7 Liraglutide, same any former antihyperglycaemic intervention, may step-up the hazard of hypoglycemia, peculiarly in compounding with insulin secretagogues.7
Novo Nordisk standard selling say-so for liraglutide on 30 June 2009 in the EU, 20 January 2010 in Japan and 25 January 2010 in the US. It has been launched in the US, UK, Germany, and various over-the-counter European markets.
1.Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, S?ndergaard RE, Davies M, for the 1860-LIRA-DPP-4-Study Group. Liraglutide versus sitagliptin for patients with case 2 diabetes who did not deliver passable glycaemic mastery with glucophage: a 26-week, randomized, parallel-group, open-label tribulation. Lancet 2010; 375 (9724): 1447-1456.
2.National Collaborating Centre for Chronic Conditions. Type 2 diabetes: subject clinical guidepost for direction in chief and lowly maintenance (update). London: Royal College of Physicians, 2008.
3.Novo Nordisk information on register, 2010.
4.Triplitt,C. et al. The ever-changing landscape of case 2 diabetes: the character of incretin-based therapies in managed maintenance outcomes. Journal of Managed Care Pharmacy. Suppl 13, S2-16.
5.Nathan DM, et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. A Consensus Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203.
6.Rodbard HW, et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology Consensus Panel on Type 2 Diabetes Mellitus: An Algorithm for Glycemic Control. Endocrine Practice . 2009; 15: September/October.
7.Victoza® Summary of Product Characteristics (SPC) is uncommitted at novonordisk.com. Victoza ® has commercialize empowerment in the EU and US.
8.Marre M et al. Liraglutide, a once-daily hum GLP-1 linear, added to a sulphonylurea terminated 26 weeks produces greater improvements in glycaemic and weightiness ascendence compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabetic Medicine. 2009; 26:268-278.
9.Nauck M et al. Efficacy and safe comparing of liraglutide, glimepiride, and placebo, all in compounding with glucophage, in case 2 diabetes. The LEAD (Liraglutide Effect and Action in Diabetes)-2 survey. Diabetes Care. 2009; 32:84-90.
10.Russell-Jones D et al. Liraglutide vs insulin glargine and placebo in combining with glucophage and sulphonylurea therapy in typecast 2 diabetes mellitus: a randomized controlled test (LEAD-5 met+SU). Diabetologia. 2009; 52:2046-55.
11.Buse J, et al. Liraglutide formerly a day versus exenatide doubly a day for typecast 2 diabetes: a 26-week randomized, parallel-group, transnational, open-label tribulation (LEAD-6). Lancet. 2009; 374:39-47.
12.Zinman B et al. Efficacy and refuge of the buzz glucagon-like peptide-1 analogue liraglutide in compounding with glucophage and thiazolidinedione in patients with case 2 diabetes mellitus (LEAD-4 Met+TZD). Diabetes Care. 2009;32:1224-1230.
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