Safety and effectiveness of biphasic insulin aspart 30 in different age-groups: a1chieve sub-analysis

Mohammad Ebrahim Khamseh, Jihad Haddad, Wenying Yang, Alexey Zilov, Ole Molskov Bech, Mohammad Imtiaz Hasan, Mohammad Ebrahim Khamseh, Jihad Haddad, Wenying Yang, Alexey Zilov, Ole Molskov Bech, Mohammad Imtiaz Hasan

Abstract

Introduction: Effective management of type 2 diabetes requires sustained glycemic control over many years, which can be particularly challenging for elderly people. This sub-analysis of the A1chieve study evaluated the clinical safety and effectiveness of biphasic insulin aspart 30 in 3 age-groups (≤40, >40-65, and >65 years) of previously insulin-experienced and insulin-naïve people with type 2 diabetes.

Methods: A1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who had been receiving anti-diabetes medication before starting, or switching to, therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone or in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of biphasic insulin aspart 30 (±oral glucose-lowering drugs) in different age-groups.

Results: Data on 40,122 participants were included. In all age-groups, the proportion of participants experiencing any hypoglycemia, major hypoglycemia or nocturnal hypoglycemia was significantly reduced from baseline, except for the following in insulin-naïve patients: a significant increase in any hypoglycemia in patients aged >65 years; no change in any hypoglycemia, major hypoglycemia, and nocturnal hypoglycemia in patients aged >40-65, ≤40, and >65 years, respectively. Significant improvements at 24 weeks vs. baseline were observed in insulin-experienced and insulin-naïve participants for: glycated hemoglobin (change from baseline ranged from -1.8% to -2.4%); fasting plasma glucose (from -3.0 to -4.3 mmol/l); post-breakfast post-prandial plasma glucose (from -4.1 to -6.5 mmol/l); and health-related quality of life (HRQoL). Sixteen serious adverse drug reactions were reported.

Conclusion: After 24-week treatment with biphasic insulin aspart 30, all age-groups of insulin-experienced and insulin-naïve patients experienced significantly improved glycemic control and HRQoL; incidence of hypoglycemia was generally reduced. The tolerability and effectiveness of biphasic insulin aspart 30 may benefit all age-groups.

References

    1. International Diabetes Federation. IDF Diabetes Atlas. 4th ed. International Diabetes Federation, Belgium; 2009.
    1. Cowie CC, Rust KF, Ford ES, et al. Full accounting of diabetes and pre-diabetes in the US population in 1988–1994 and 2005–2006. Diabetes Care. 2009;32:287–294. doi: 10.2337/dc08-1296.
    1. Mooradian AD, McLaughlin S, Boyer CC, Winter J. Diabetes care for older adults. Diabetes Spectr. 1999;12:70–77.
    1. Geddes J, Schopman JE, Zammitt NN, Frier BM. Prevalence of impaired awareness of hypoglycaemia in adults with type 1 diabetes. Diabet Med. 2008;25:501–504. doi: 10.1111/j.1464-5491.2008.02413.x.
    1. Chan TY. Estimates on the incidence of antidiabetic drug-induced severe hypoglycaemia in Hong Kong. Pharmacoepidemiol Drug Saf. 1998;7:411–414. doi: 10.1002/(SICI)1099-1557(199811/12)7:6<411::AID-PDS379>;2-U.
    1. Brown AF, Mangione CM, Saliba D, Sarkisian CA. Guidelines for improving the care of the older person with diabetes mellitus. J Am Geriatr Soc. 2003;51:S265–S280.
    1. Korytkowski M. When oral agents fail: practical barriers to starting insulin. Int J Obes Relat Metab Disord. 2005;26(Suppl. 3):S18–S24.
    1. Peyrot M, Rubin RR, Lauritzen T, et al. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673–2679. doi: 10.2337/diacare.28.11.2673.
    1. Dornhorst A, Luddeke HJ, Sreenan S, et al. Insulin detemir improves glycaemic control without weight gain in insulin-naive patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract. 2008;62:659–665. doi: 10.1111/j.1742-1241.2008.01715.x.
    1. Fajardo Montanana C, Hernandez Herrero C, Rivas Fernandez M. Less weight gain and hypoglycaemia with once-daily insulin detemir than NPH insulin in intensification of insulin therapy in overweight type 2 diabetes patients: the PREDICTIVE BMI clinical trial. Diabet Med. 2008;25:916–923. doi: 10.1111/j.1464-5491.2008.02483.x.
    1. Hermansen K, Davies M, Derezinski T, Martinez Ravn G, Clauson P, Home P. A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetes Care. 2006;29:1269–1274. doi: 10.2337/dc05-1365.
    1. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B. Comparison of insulin analogue regimens in people with type 2 diabetes mellitus in the PREFER study: a randomized controlled trial. Diabetes Obes Metab. 2009;11:45–52. doi: 10.1111/j.1463-1326.2008.00915.x.
    1. Meneghini L, Mersebach H, Kumar S, Svendsen AL, Hermansen K. Comparison of 2 intensification regimens with rapid-acting insulin aspart in type 2 diabetes mellitus inadequately controlled by once-daily insulin detemir and oral antidiabetes drugs: the step-wise randomized study. Endocr Pract. 2011;17:727–736. doi: 10.4158/EP10367.OR.
    1. Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006;28:1569–1581. doi: 10.1016/j.clinthera.2006.10.020.
    1. Sharma S, Al-Mustafa M, Oh S, et al. Biphasic insulin aspart 30 treatment in patients with type 2 diabetes poorly controlled on prior diabetes treatment: results from the PRESENT study. Curr Med Res Opin. 2008;24:645–652. doi: 10.1185/030079908X260952.
    1. Valensi P, Benroubi M, Borzi V, et al. The IMPROVE study–a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts. Int J Clin Pract. 2008;62:1809–1819. doi: 10.1111/j.1742-1241.2008.01917.x.
    1. Warren ML, Conway MJ, Klaff LJ, Rosenstock J, Allen E. Postprandial versus preprandial dosing of biphasic insulin aspart in elderly type 2 diabetes patients. Diabetes Res Clin Pract. 2004;66:23–29. doi: 10.1016/j.diabres.2004.02.010.
    1. Garber AJ, Wahlen J, Wahl T, et al. Attainment of glycaemic goals in type 2 diabetes with once-, twice-, or thrice-daily dosing with biphasic insulin aspart 70/30 (the 1-2-3 study) Diabetes Obes Metab. 2006;8:58–66. doi: 10.1111/j.1463-1326.2005.00563.x.
    1. Raskin P, Allen E, Hollander P, et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic and basal insulin analogs. Diabetes Care. 2005;28:260–265. doi: 10.2337/diacare.28.2.260.
    1. Hermansen K, Colombo M, Storgaard H, Ostergaard A, Kolendorf K, Madsbad S. Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients with type 2 diabetes. Diabetes Care. 2002;25:883–888. doi: 10.2337/diacare.25.5.883.
    1. Strojek K, Bebakar WM, Khutsoane DT, et al. Once-daily initiation with biphasic insulin aspart 30 versus insulin glargine in patients with type 2 diabetes inadequately controlled with oral drugs: an open-label, multinational RCT. Curr Med Res Opin. 2009;25:2887–2894. doi: 10.1185/03007990903354674.
    1. Boehm BO, Home PD, Behrend C, Kamp NM, Lindholm A. Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in type 1 and type 2 diabetic patients. Diabet Med. 2002;19:393–399. doi: 10.1046/j.1464-5491.2002.00733.x.
    1. Boehm BO, Vaz JA, Brondsted L, Home PD. Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. Eur J Intern Med. 2004;15:496–502. doi: 10.1016/j.ejim.2004.10.001.
    1. Home P, Naggar NE, Khamseh M, et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract. 2011;94:352–363. doi: 10.1016/j.diabres.2011.10.021.
    1. World Medical Association. Declaration of Helsinki—ethical principles for medical research involving human subjects 2008. . Accessed Nov 8, 2011.
    1. International Society for Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practices (GPP). Revision 2, Apr 2007. . Accessed Jul 2, 2013.
    1. The EuroQol group EuroQol—a new facility for the measurement of health-related quality of life. EuroQol Group Health Policy. 1990;16:199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Trippe BS, Shepherd MD, Coulter FC, et al. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial) Curr Med Res Opin. 2012;28:1203–1211. doi: 10.1185/03007995.2012.686444.
    1. Ligthelm RJ, Kaiser M, Vora J, Yale JF. Insulin use in elderly adults: risk of hypoglycemia and strategies for care. J Am Geriatr Soc. 2012;60:1564–1570. doi: 10.1111/j.1532-5415.2012.04055.x.
    1. Valensi P. Biphasic insulin aspart 30/70 (BIAsp 30) in the treatment of type 1 and type 2 diabetes. Diabetes, Metab Syndr Obes Targets Ther. 2009;2:61–71. doi: 10.2147/DMSOTT.S3408.
    1. Qayyum R, Bolen S, Maruthur N, et al. Systematic review: comparative effectiveness and safety of premixed insulin analogues in type 2 diabetes. Ann Intern Med. 2008;149:549–559. doi: 10.7326/0003-4819-149-8-200810210-00242.
    1. Holman RR, Thorne KI, Farmer AJ, et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med. 2007;357:1716–1730. doi: 10.1056/NEJMoa075392.
    1. Shah S, Zilov A, Malek R, Soewondo P, Bech O, Litwak L. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract. 2011;94:364–370. doi: 10.1016/j.diabres.2011.10.020.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner