Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naïve adults with Type 2 diabetes

. 2016 Apr ; 33 (4) : 497-505. [epub] 20151117

Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic

Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid26435365

AIM: To evaluate the efficacy and safety of twice-daily insulin degludec/insulin aspart vs. twice-daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were naïve to insulin. METHODS: In this 26-week, multinational, open-label, controlled, two-arm, parallel-group, treat-to-target trial, participants [mean (± sd) age 58.9 (±8.9) years, duration of diabetes 9.5 (±5.9) years, HbA1c 68 (±8.7) mmol/mol or 8.4 (±0.8)% and BMI 31.2 (±4.2) kg/m(2) ) were randomized (1:1) to insulin degludec/insulin aspart (n = 197) or biphasic insulin aspart 30 (n = 197), administered with breakfast and the main evening meal, titrated to a self-monitored plasma glucose target > 3.9 and ≤ 5.0 mmol/l. RESULTS: The mean HbA1c was reduced to 49 mmol/mol (6.6%) with insulin degludec/insulin aspart and 48 mmol/mol (6.5%) with biphasic insulin aspart 30. Insulin degludec/insulin aspart achieved the prespecified non-inferiority margin (estimated treatment difference 0.02%; 95% CI -0.12, 0.17). Insulin degludec/insulin aspart was superior in lowering fasting plasma glucose (estimated treatment difference -1.00 mmol/l; 95% CI -1.4, -0.6; P < 0.001) and reducing overall and nocturnal confirmed hypoglycaemia at a similar overall insulin dose compared with biphasic insulin aspart 30. Similar proportions of participants in each arm experienced severe hypoglycaemia. Adverse events were equally distributed. CONCLUSIONS: Consistent with previous findings, insulin degludec/insulin aspart twice daily effectively improved long-term glycaemic control, with superior reductions in FPG, and significantly less overall and nocturnal confirmed hypoglycaemia compared with biphasic insulin aspart 30 in people with Type 2 diabetes who were insulin-naïve.

Zobrazit více v PubMed

Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10‐year follow‐up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359: 1577–1589. PubMed

Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M et al Management of hyperglycemia in type 2 diabetes: a patient‐centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012; 35: 1364–1379. PubMed PMC

Haque M, Emerson SH, Dennison CR, Navsa M, Levitt NS. Barriers to initiating insulin therapy in patients with type 2 diabetes mellitus in public‐sector primary health care centres in Cape Town. S Afr Med J 2005; 95: 798–802. PubMed

Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care 2010; 33: 240–245. PubMed PMC

Vaag A, Lund SS. Insulin initiation in patients with type 2 diabetes mellitus: treatment guidelines, clinical evidence and patterns of use of basal vs premixed insulin analogues. Eur J Endocrinol 2012; 166: 159–170. PubMed PMC

Jonassen I, Havelund S, Hoeg‐Jensen T, Steensgaard DB, Wahlund PO, Ribel U. Design of the novel protraction mechanism of insulin degludec, an ultra‐long‐acting basal insulin. Pharm Res 2012; 29: 2104–2114. PubMed PMC

Heise T, Nosek L, Roepstorff C, Chenji S, Klein O, Haahr H. Distinct prandial and basal glucose‐lowering effects of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes mellitus. Diabetes Ther 2014; 5: 255–265. PubMed PMC

Havelund S, Ribel U, Hubalek F, Hoeg‐Jensen T, Jonassen IB. Insulin degludec (IDeg) and insulin aspart (IAsp) can be coformulated such that the formulation of IDeg multi‐hexamers and IAsp monomers is retained upon S.C. injection. Diabetes 2013; 62 (Suppl 1): A241:945‐P.

Heise T, Nosek L, Klein O, Coester HV, Roepstorff C, Svendsen AL et al IDegAsp produces dose‐proportional glucose‐lowering effect in subjects with type 1 diabetes. Diabetes 2013; 62 (Suppl 1): A241:947‐P. PubMed

Heise T, Nosek L, Klein O, Coester HV, Svendsen AL, Haahr H. Insulin degludec/insulin aspart produces a dose‐proportional glucose‐lowering effect in subjects with type 1 diabetes mellitus. Diabetes Obes Metab 2015; 17: 659–664. PubMed

Heise T, Nosek L, Klein O, Hastrup H, Chenji S, Haahr H. Insulin degludec/insulin aspart has distinct prandial and basal glucose‐lowering effects at steady state in subjects with type 1 diabetes. Diabetes 2013; 62(Suppl 1): A235. PubMed PMC

Heise T, Eckers U, Kanc K, Nielsen JN, Nosek L. The pharmacokinetic and pharmacodynamic properties of different formulations of biphasic insulin aspart: a randomized, glucose clamp, crossover study. Diabetes Technol Ther 2008; 10: 479–485. PubMed

Fulcher GR, Christiansen JS, Bantwal G, Polaszewska‐Muszynska M, Mersebach H, Andersen TH et al Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled, insulin‐treated type 2 diabetes: a phase 3a, randomized, treat‐to‐target trial. Diabetes Care 2014; 37: 2084–2090. PubMed

Kaneko S, Chow F, Choi DS, Taneda S, Hirao K, Park Y et al Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre‐/self‐mixed insulin: a 26‐week, randomised, treat to target trial. Diabetes Res Clin Pract 2015; 107: 139–147. PubMed

Novo Nordisk A/S . Ryzodeg Summary of Product Characteristics, 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002499/WC500139011.pdf. Accessed 12 November 2014.

Food and Drug Administration . Guidelines for Industry, diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention, 2008. Available at http://www.fda.gov/downloads/Drugs/Guidances/ucm071624.pdf Accessed 12 November 2014.

World Medical Association . World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 2013; 310; 2191–2194. PubMed

International Conference of Harmonising . ICH Harmonised Tripartate Guideline‐Guideline for Good Clinical Practice, 1996. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. Last accessed 12 November 2014.

Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Muñoz‐Torres M et al Comparison of a soluble co‐formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol 2012; 167: 287–294. PubMed PMC

Vaag A, Sandahl‐Christiansen J, Niskanen L, Johansen T, Rasmussen S, Fulcher G. Lower rates of overall, nocturnal and severe hypoglycaemia during maintenance treatment with IDegAsp vs biphasic insulin aspart 30 in patients with type 2 diabetes mellitus: a meta‐analysis. Presented at EASD, 23–27 September 2013, Barcelona, Spain. Oral presentation #187.

Rodbard HW, Cariou B, Zinman B, Handelsman Y, Philis‐Tsimikas A, Skjøth TV et al Comparison of insulin degludec with insulin glargine in insulin‐naive subjects with Type 2 diabetes: a 2‐year randomized, treat‐to‐target trial. Diabet Med 2013; 30: 1298–1304. PubMed PMC

Chow E, Bernjak A, Williams S, Fawdry RA, Hibbert S, Freeman J et al Risk of cardiac arrhythmias during hypoglycemia in patients with type 2 diabetes and cardiovascular risk. Diabetes 2014; 63: 1738–1747. PubMed

EMA . NovoRapid: EPAR – Product Information, 2009. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000258/WC500030372.pdf Last accessed 12 November 2014.

Najít záznam

Citační ukazatele

Nahrávání dat ...

Možnosti archivace

Nahrávání dat ...