Review of biphasic insulin aspart in the treatment of type 1 and 2 diabetes

Background Insulin is an effective treatment for achieving glycemic control and preventing complications in patients with diabetes. In order to make insulin therapy more acceptable to patients, newer formulations of insulin have been developed, such as biphasic insulins. Biphasic insulins conveniently provide both prandial and basal insulin in a single injection. One of the most well-studied biphasic insulins is biphasic insulin aspart 70/30. Objective Our goal was to review the current literature on the safety and efficacy of biphasic insulin aspart in type 1 and type 2 diabetes. Methods A MEDLINE search was conducted using the terms “biphasic insulin aspart” to identify clinical studies and reviews. Results Biphasic insulin aspart more effectively reduces post-prandial glucose compared to other biphasic insulins and basal insulins. Compared to biphasic insulin aspart, fasting glucose levels are lower with NPH, similar with glargine, and similar or lower with biphasic human insulin. Treat-to-target trials have shown that a goal HbA1c below 6.5 or 7% can be achieved with biphasic insulin aspart. The risk of hypoglycemia is similar to or less than that seen with other biphasic insulins or NPH insulin. Conclusion Biphasic insulin aspart 70/30 is a safe and effective treatment option for patients with diabetes.

[1]  S. Mudaliar,et al.  Insulin therapy in type 2 diabetes. , 2001, Endocrinology and metabolism clinics of North America.

[2]  M. Hanefeld,et al.  Postchallenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level. , 2000, Diabetes care.

[3]  L. Niskanen,et al.  Randomized, multinational, open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispro 25 and pen devices in adult patients with type 2 diabetes mellitus. , 2004, Clinical therapeutics.

[4]  T. Wascher,et al.  Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. , 2006, Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association.

[5]  Lawrence A Leiter,et al.  Postprandial glucose regulation: new data and new implications. , 2005, Clinical therapeutics.

[6]  P. Raskin,et al.  Starting patients with type 2 diabetes on insulin therapy using once-daily injections of biphasic insulin aspart 70/30, biphasic human insulin 70/30, or NPH insulin in combination with metformin. , 2003, Journal of diabetes and its complications.

[7]  S. Wild,et al.  Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. , 2004, Diabetes care.

[8]  Initiating Insulin Therapy in Type 2 Diabetes: A Comparison of Biphasic and Basal Insulin AnalogsRaskin P, for the INITIATE Study Group (Univ of Texas, Dallas; et al) Diabetes Care 28:260–265, 2005§ , 2006 .

[9]  Michael Stumvoll,et al.  Type 2 diabetes: principles of pathogenesis and therapy , 2005, The Lancet.

[10]  P. Raskin,et al.  Efficacy of biphasic insulin aspart in patients with type 2 diabetes. , 2005, Clinical therapeutics.

[11]  S. Bowlin,et al.  Glycemic control from 1988 to 2000 among U.S. adults diagnosed with type 2 diabetes: a preliminary report. , 2004, Diabetes care.

[12]  J. Tuomilehto,et al.  Is the current definition for diabetes relevant to mortality risk from all causes and cardiovascular and noncardiovascular diseases? , 2003, Diabetes care.

[13]  A. Garber,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) , 2006, Diabetes, obesity & metabolism.

[14]  B. Zinman,et al.  Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. , 2005, The New England journal of medicine.

[15]  B. Boehm,et al.  Premixed insulin aspart 30 vs. premixed human insulin 30/70 twice daily: a randomized trial in Type 1 and Type 2 diabetic patients , 2002, Diabetic medicine : a journal of the British Diabetic Association.

[16]  L. Niskanen,et al.  FlexPen: addressing issues of confidence and convenience in insulin delivery. , 2005, Clinical therapeutics.

[17]  Robert A Gabbay,et al.  Initiating insulin therapy in type 2 Diabetes: a comparison of biphasic and basal insulin analogs. , 2005, Diabetes care.

[18]  P. Home,et al.  Comparative pharmacokinetics and pharmacodynamics of the novel rapid-acting insulin analogue, insulin aspart, in healthy volunteers , 1999, European Journal of Clinical Pharmacology.

[19]  A. Riis,et al.  Pharmacokinetics and pharmacodynamics of a premixed formulation of soluble and protamine-retarded insulin aspart , 2000, European Journal of Clinical Pharmacology.

[20]  B. Boehm,et al.  Long-term efficacy and safety of biphasic insulin aspart in patients with type 2 diabetes. , 2004, European journal of internal medicine.

[21]  H. Lebovitz,et al.  ACE/AACE consensus conference on the implementation of outpatient management of diabetes mellitus: consensus conference recommendations. , 2006, Endocrine Practice.

[22]  V. Basevi Standards of medical care in diabetes--2007. , 2009, Diabetes care.

[23]  I. Raz,et al.  Efficacy and safety of biphasic insulin aspart 30 combined with pioglitazone in type 2 diabetes poorly controlled on glibenclamide (glyburide) monotherapy or combination therapy: an 18-week, randomized, open-label study. , 2005, Clinical therapeutics.

[24]  K. Begtrup,et al.  Postprandial glycemic control with biphasic insulin aspart in patients with type 1 diabetes. , 2002, Metabolism: clinical and experimental.

[25]  I. Deary,et al.  Hypoglycaemia in insulin‐treated Type 2 diabetes: frequency, symptoms and impaired awareness , 2003, Diabetic medicine : a journal of the British Diabetic Association.

[26]  K. Hermansen,et al.  Improved postprandial glycemic control with biphasic insulin aspart relative to biphasic insulin lispro and biphasic human insulin in patients with type 2 diabetes. , 2002, Diabetes care.

[27]  Brigitte L. Sicat,et al.  New therapeutic options for the management of diabetes. , 2007, The Consultant pharmacist : the journal of the American Society of Consultant Pharmacists.

[28]  B. Ludvik,et al.  Improvement of glucose tolerance in type 2 diabetic patients: traditional vs. modern insulin regimens (results from the Austrian Biaspart Study). , 2005, Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme.

[29]  P. Raskin,et al.  Basal insulin or premix analogue therapy in type 2 diabetes patients. , 2007, European journal of internal medicine.

[30]  Idf Clinical Guidelines Task Force Global Guideline for Type 2 Diabetes: recommendations for standard, comprehensive, and minimal care , 2006, Diabetic medicine : a journal of the British Diabetic Association.

[31]  J. Nolan,et al.  The cost of treating type 2 diabetes (CODEIRE). , 2006, Irish medical journal.

[32]  R. Landgraf The relationship of postprandial glucose to HbA1c , 2004, Diabetes/metabolism research and reviews.

[33]  L. Heinemann,et al.  Reduced postprandial glycaemic excursion with biphasic insulin Aspart 30 injected immediately before a meal , 2004, Diabetic medicine : a journal of the British Diabetic Association.

[34]  Uk-Prospective-Diabetes-Study-Group Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33) , 1998, The Lancet.

[35]  Dennis D. Kim,et al.  A comparison of twice-daily exenatide and biphasic insulin aspart in patients with type 2 diabetes who were suboptimally controlled with sulfonylurea and metformin: a non-inferiority study , 2007, Diabetologia.

[36]  P. Raskin,et al.  Immune responses to insulin aspart and biphasic insulin aspart in people with type 1 and type 2 diabetes. , 2002, Diabetes care.

[37]  Lawrence Blonde,et al.  Current challenges in diabetes management. , 2005, Clinical cornerstone.

[38]  J. Frystyk,et al.  Impact of insulin antibodies on insulin aspart pharmacokinetics and pharmacodynamics after 12-week treatment with multiple daily injections of biphasic insulin aspart 30 in patients with type 1 diabetes. , 2005, European journal of endocrinology.

[39]  R. Holman,et al.  Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. , 1998 .

[40]  R. Rakel,et al.  Practical approaches to insulin therapy for type 2 diabetes mellitus with premixed insulin analogues. , 2005, Clinical therapeutics.

[41]  M. Landin-Olsson,et al.  Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. , 2006, Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association.

[42]  J. Christiansen,et al.  Twice daily biphasic insulin aspart improves postprandial glycaemic control more effectively than twice daily NPH insulin, with low risk of hypoglycaemia, in patients with type 2 diabetes , 2003, Diabetes, obesity & metabolism.

[43]  M. Kvapil,et al.  Biphasic insulin aspart 30 plus metformin: an effective combination in type 2 diabetes , 2006, Diabetes, obesity & metabolism.

[44]  N. Clark,et al.  Standards of Medical Care in Diabetes: Response to Power , 2006 .

[45]  Matthew D. Davis,et al.  Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. , 2000, The New England journal of medicine.

[46]  A. Palmer,et al.  Comments on Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin-naïve type 2 diabetes patients: cost-effectiveness analysis in the UK setting , 2005, Current medical research and opinion.

[47]  S. Majumdar,et al.  Health Care Use and Costs in the Decade After Identification of Type 1 and Type 2 Diabetes , 2006, Diabetes Care.

[48]  R. Rakel,et al.  Why, when and how to initiate insulin therapy in patients with type 2 diabetes , 2007, International journal of clinical practice.

[49]  A. Bojesen,et al.  Multiple mealtime administration of biphasic insulin aspart 30 versus traditional basal‐bolus human insulin treatment in patients with type 1 diabetes , 2006, Diabetes, obesity & metabolism.

[50]  D. Cucinotta,et al.  Biphasic insulin aspart 30: literature review of adverse events associated with treatment. , 2005, Clinical therapeutics.

[51]  P. Raskin,et al.  Insulin therapy in type 2 diabetes patients failing oral agents: cost‐effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US * , 2007, Diabetes, obesity & metabolism.

[52]  A. Lindholm,et al.  Twice-daily biphasic insulin aspart 30 versus biphasic human insulin 30: a double-blind crossover study in adults with type 2 diabetes mellitus. , 2002, Clinical therapeutics.

[53]  Claude Colette,et al.  Contributions of fasting and postprandial plasma glucose increments to the overall diurnal hyperglycemia of type 2 diabetic patients: variations with increasing levels of HbA(1c). , 2003, Diabetes care.

[54]  H. Mortensen,et al.  Biphasic insulin aspart vs. human insulin in adolescents with type 1 diabetes on multiple daily insulin injections , 2006, Pediatric diabetes.

[55]  J. Rosenstock,et al.  The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. , 2003, Diabetes care.

[56]  T. Wascher,et al.  Biphasic insulin aspart compared to biphasic human insulin reduces postprandial hyperlipidemia in patients with Type 2 diabetes. , 2005, Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association.