The use of insulin detemir during pregnancy: a safety evaluation

Bibliography

• Group HSCR. Metzger BE, Lowe LP, et al. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med 2008;358(19):1991-2002
   PubMed Web of Science ®Google Scholar
• American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2009;32(Suppl 1):S62-7
   PubMed Web of Science ®Google Scholar
• Lawrence JM, Contreras R, Chen W, et al. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes care 2008;31(5):899-904
   PubMed Web of Science ®Google Scholar
• Moyer VA; Force USPST. Screening for gestational diabetes mellitus: U.S. preventive services task force recommendation statement. Ann Intern Med 2014;160(6):414-20
   PubMed Web of Science ®Google Scholar
• Hartling L, Dryden DM, Guthrie A, et al. Screening and diagnosing gestational diabetes mellitus. Evid Rep Technol Assess (Full Rep) 2012(210):1-327
   PubMedGoogle Scholar
• Ferrara A. Increasing prevalence of gestational diabetes mellitus: a public health perspective. Diabetes Care 2007;30(Suppl 2):S141-6
   PubMed Web of Science ®Google Scholar
• Page RC, Kirk BA, Fay T, et al. Is macrosomia associated with poor glycaemic control in diabetic pregnancy? Diabet Med 1996;13(2):170-4
   PubMed Web of Science ®Google Scholar
• Greene MF. Spontaneous abortions and major malformations in women with diabetes mellitus. Semin Reprod Endocrinol 1999;17(2):127-36
   PubMedGoogle Scholar
• Sibai BM, Caritis SN, Hauth JC, et al. Preterm delivery in women with pregestational diabetes mellitus or chronic hypertension relative to women with uncomplicated pregnancies. The national institute of child health and human development maternal- fetal medicine units network. Am J Obstet Gynecol 2000;183(6):1520-4
   PubMed Web of Science ®Google Scholar
• McElvy SS, Miodovnik M, Rosenn B, et al. A focused preconceptional and early pregnancy program in women with type 1 diabetes reduces perinatal mortality and malformation rates to general population levels. J Matern Fetal Med 2000;9(1):14-20
   PubMedGoogle Scholar
• Evers IM, de Valk HW, Visser GH. Risk of complications of pregnancy in women with type 1 diabetes: nationwide prospective study in the Netherlands. BMJ 2004;328(7445):915
   PubMed Web of Science ®Google Scholar
• Dunne F. Type 2 diabetes and pregnancy. Semin Fetal Neonatal Med 2005;10(4):333-9
   PubMed Web of Science ®Google Scholar
• Jensen DM, Damm P, Moelsted-Pedersen L, et al. Outcomes in type 1 diabetic pregnancies: a nationwide, population-based study. Diabet care 2004;27(12):2819-23
   PubMed Web of Science ®Google Scholar
• Jensen DM, Damm P, Sorensen B, et al. Clinical impact of mild carbohydrate intolerance in pregnancy: a study of 2904 nondiabetic Danish women with risk factors for gestational diabetes mellitus. Am J Obstet Gynecol 2001;185(2):413-19
   PubMed Web of Science ®Google Scholar
• Jensen DM, Korsholm L, Ovesen P, et al. Adverse pregnancy outcome in women with mild glucose intolerance: is there a clinically meaningful threshold value for glucose? Acta Obstet Gynecol Scand 2008;87(1):59-62
   PubMed Web of Science ®Google Scholar
• Ferrara A, Weiss NS, Hedderson MM, et al. Pregnancy plasma glucose levels exceeding the american diabetes association thresholds, but below the national diabetes data group thresholds for gestational diabetes mellitus, are related to the risk of neonatal macrosomia, hypoglycaemia and hyperbilirubinaemia. Diabetologia 2007;50(2):298-306
   PubMed Web of Science ®Google Scholar
• Sermer M, Naylor CD, Gare DJ, et al. Impact of increasing carbohydrate intolerance on maternal-fetal outcomes in 3637 women without gestational diabetes. The toronto tri-hospital gestational diabetes project. Am J Obstet Gynecol 1995;173(1):146-56
   PubMed Web of Science ®Google Scholar
• Hartling L, Dryden DM, Guthrie A, et al. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. preventive services task force and the national institutes of health office of medical applications of research. Ann Intern Med 2013;159(2):123-9
   PubMed Web of Science ®Google Scholar
• Kitzmiller JL, Block JM, Brown FM, et al. Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabet care 2008;31(5):1060-79
   PubMed Web of Science ®Google Scholar
• Langer O, Conway DL, Berkus MD, et al. A comparison of glyburide and insulin in women with gestational diabetes mellitus. N Engl J Med 2000;343(16):1134-8
   PubMed Web of Science ®Google Scholar
• Langer O, Yogev Y, Xenakis EM, et al. Insulin and glyburide therapy: dosage, severity level of gestational diabetes, and pregnancy outcome. Am J Obstet Gynecol 2005;192(1):134-9
   PubMed Web of Science ®Google Scholar
• Knox CA, Delaney JA, Winterstein AG. Anti-diabetic drug utilization of pregnant diabetic women in us managed care. BMC Pregnancy Childbirth 2014;14:28
   PubMed Web of Science ®Google Scholar
• Hermansen K, Fontaine P, Kukolja KK, et al. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia 2004;47(4):622-9
   PubMed Web of Science ®Google Scholar
• Home PD, Lindholm A, Riis A, et al. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabet Med 2000;17(11):762-70
   PubMed Web of Science ®Google Scholar
• Rosenstock J, Schwartz SL, Clark CMJr, et al. Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE 901) and NPH insulin. Diabet care 2001;24(4):631-6
   PubMed Web of Science ®Google Scholar
• Wyatt JW, Frias JL, Hoyme HE, et al. Congenital anomaly rate in offspring of mothers with diabetes treated with insulin lispro during pregnancy. Diabet Med 2005;22(6):803-7
   PubMed Web of Science ®Google Scholar
• Lapolla A, Dalfra MG, Spezia R, et al. Outcome of pregnancy in type 1 diabetic patients treated with insulin lispro or regular insulin: an Italian experience. Acta Diabetol 2008;45(1):61-6
   PubMed Web of Science ®Google Scholar
• Hod M, Damm P, Kaaja R, et al. Fetal and perinatal outcomes in type 1 diabetes pregnancy: a randomized study comparing insulin aspart with human insulin in 322 subjects. Am J Obstet Gynecol 2008;198(2):186 e1-7
   PubMed Web of Science ®Google Scholar
• Mathiesen ER, Kinsley B, Amiel SA, et al. Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women. Diabet Care 2007;30(4):771-6
   PubMed Web of Science ®Google Scholar
• Di Cianni G, Volpe L, Ghio A, et al. Maternal metabolic control and perinatal outcome in women with gestational diabetes mellitus treated with lispro or aspart insulin: comparison with regular insulin. Diabet Care 2007;30(4):e11
   PubMed Web of Science ®Google Scholar
• Mecacci F, Carignani L, Cioni R, et al. Maternal metabolic control and perinatal outcome in women with gestational diabetes treated with regular or lispro insulin: comparison with non-diabetic pregnant women. Eur J Obstet Gynecol Reprod Biol 2003;111(1):19-24
   PubMed Web of Science ®Google Scholar
• Imbergamo MP, Amato MC, Sciortino G, et al. Use of glargine in pregnant women with type 1 diabetes mellitus: a case-control study. Clin Ther 2008;30(8):1476-84
   PubMed Web of Science ®Google Scholar
• Poyhonen-Alho M, Ronnemaa T, Saltevo J, et al. Use of insulin glargine during pregnancy. Acta Obstet Gynecol Scand 2007;86(10):1171-4
   PubMed Web of Science ®Google Scholar
• Price N, Bartlett C, Gillmer M. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG 2007;114(4):453-7
   PubMed Web of Science ®Google Scholar
• Lambert K, Holt RI. The use of insulin analogues in pregnancy. Diabetes Obes Metab 2013;15(10):888-900
   PubMed Web of Science ®Google Scholar
• FDA. Highlights of prescribing information to use LEVEMIR. 2013 revised 10/2013
   Google Scholar
• Mathiesen ER, Hod M, Ivanisevic M, et al. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabet Care 2012;35(10):2012-17
   PubMed Web of Science ®Google Scholar
• Dea MK, Hamilton-Wessler M, Ader M, et al. Albumin binding of acylated insulin (NN304) does not deter action to stimulate glucose uptake. Diabetes 2002;51(3):762-9
   PubMed Web of Science ®Google Scholar
• Markussen J, Havelund S, Kurtzhals P, et al. Soluble, fatty acid acylated insulins bind to albumin and show protracted action in pigs. Diabetologia 1996;39(3):281-8
   PubMed Web of Science ®Google Scholar
• Arnolds S, Kuglin B, Kapitza C, et al. How pharmacokinetic and pharmacodynamic principles pave the way for optimal basal insulin therapy in type 2 diabetes. Int J Clin Pract 2010;64(10):1415-24
   PubMed Web of Science ®Google Scholar
• Heinemann L, Sinha K, Weyer C, et al. Time-action profile of the soluble, fatty acid acylated, long-acting insulin analogue NN304. Diabet Med 1999;16(4):332-8
   PubMed Web of Science ®Google Scholar
• Plank J, Bodenlenz M, Sinner F, et al. A double-blind, randomized, dose-response study investigating the pharmacodynamic and pharmacokinetic properties of the long-acting insulin analog detemir. Diabetes Care 2005;28(5):1107-12
   PubMed Web of Science ®Google Scholar
• Klein O, Lynge J, Endahl L, et al. Albumin-bound basal insulin analogues (insulin detemir and NN344): comparable time-action profiles but less variability than insulin glargine in type 2 diabetes. Diabetes Obes Metab 2007;9(3):290-9
   PubMed Web of Science ®Google Scholar
• Heise T, Pieber TR. Towards peakless, reproducible and long-acting insulins. An assessment of the basal analogues based on isoglycaemic clamp studies. Diabetes Obes Metab 2007;9(5):648-59
   PubMed Web of Science ®Google Scholar
• Heise T, Nosek L, Ronn BB, et al. Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 2004;53(6):1614-20
   PubMed Web of Science ®Google Scholar
• Kurtzhals P, Schaffer L, Sorensen A, et al. Correlations of receptor binding and metabolic and mitogenic potencies of insulin analogs designed for clinical use. Diabetes 2000;49(6):999-1005
   PubMed Web of Science ®Google Scholar
• Zib I, Raskin P. Novel insulin analogues and its mitogenic potential. Diabetes Obes Metab 2006;8(6):611-20
   PubMed Web of Science ®Google Scholar
• Pierre-Eugene C, Pagesy P, Nguyen TT, et al. Effect of insulin analogues on insulin/IGF1 hybrid receptors: increased activation by glargine but not by its metabolites M1 and M2. PLoS ONE 2012;7(7):e41992
   PubMed Web of Science ®Google Scholar
• Bolli GB, Hahn AD, Schmidt R, et al. Plasma exposure to insulin glargine and its metabolites M1 and M2 after subcutaneous injection of therapeutic and supratherapeutic doses of glargine in subjects with type 1 diabetes. Diabetes Care 2012;35(12):2626-30
   PubMed Web of Science ®Google Scholar
• Sciacca L, Cassarino MF, Genua M, et al. Insulin analogues differently activate insulin receptor isoforms and post-receptor signalling. Diabetologia 2010;53(8):1743-53
   PubMed Web of Science ®Google Scholar
• Varewijck AJ, Goudzwaard JA, Brugts MP, et al. Insulin glargine is more potent in activating the human IGF-I receptor than human insulin and insulin detemir. Growth Horm IGF Res 2010;20(6):427-31
   PubMed Web of Science ®Google Scholar
• Pollex EK, Feig DS, Koren G. Oral hypoglycemic therapy: understanding the mechanisms of transplacental transfer. J Matern Fetal Neonatal Med 2010;23(3):224-8
   PubMed Web of Science ®Google Scholar
• Menon RK, Cohen RM, Sperling MA, et al. Transplacental passage of insulin in pregnant women with insulin-dependent diabetes mellitus. Its role in fetal macrosomia. N Engl J Med 1990;323(5):309-15
   PubMed Web of Science ®Google Scholar
• Crombach G, Siebolds M, Mies R. Insulin use in pregnancy. Clinical pharmacokinetic considerations. Clin Pharmacokinet 1993;24(2):89-100
   PubMed Web of Science ®Google Scholar
• Morello CM. Pharmacokinetics and pharmacodynamics of insulin analogs in special populations with type 2 diabetes mellitus. Int J Gen Med 2011;4:827-35
   PubMedGoogle Scholar
• de Valk HW, Visser GH. Insulin during pregnancy, labour and delivery. Best Pract Res Clin Obstet Gynaecol 2011;25(1):65-76
   PubMed Web of Science ®Google Scholar
• Murphy HR, Elleri D, Allen JM, et al. Pathophysiology of postprandial hyperglycaemia in women with type 1 diabetes during pregnancy. Diabetologia 2012;55(2):282-93
   PubMed Web of Science ®Google Scholar
• Hod M, Mathiesen ER, Jovanovic L, et al. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med 2014;27(1):7-13
   PubMed Web of Science ®Google Scholar
• Rosenn BM, Miodovnik M, Holcberg G, et al. Hypoglycemia: the price of intensive insulin therapy for pregnant women with insulin-dependent diabetes mellitus. Obstet Gynecol 1995;85(3):417-22
   PubMed Web of Science ®Google Scholar
• Pregnancy outcomes in the diabetes control and complications trial. Am J Obstet Gynecol 1996;174(4):1343-53
   PubMed Web of Science ®Google Scholar
• Nielsen LR, Pedersen-Bjergaard U, Thorsteinsson B, et al. Hypoglycemia in pregnant women with type 1 diabetes: predictors and role of metabolic control. Diabetes Care 2008;31(1):9-14
   PubMed Web of Science ®Google Scholar
• Evers IM, ter Braak EW, de Valk HW, et al. Risk indicators predictive for severe hypoglycemia during the first trimester of type 1 diabetic pregnancy. Diabetes Care 2002;25(3):554-9
   PubMed Web of Science ®Google Scholar
• Secher AL, Ringholm L, Andersen HU, et al. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care 2013;36(7):1877-83
   PubMed Web of Science ®Google Scholar
• Secher AL, Mathiesen ER, Andersen HU, et al. Severe hypoglycemia in pregnant women with type 2 diabetes-A relevant clinical problem. Diabetes Res Clin Pract 2013;102(2):e17-18
   PubMed Web of Science ®Google Scholar
• Mello G, Biagioni S, Ottanelli S, et al. Continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) of rapid-acting insulin analogues and detemir in type 1 diabetic (T1D) pregnant women. J Matern Fetal Neonatal Med 2014;1-6
   Google Scholar
• Callesen NF, Damm J, Mathiesen JM, et al. Treatment with the long-acting insulin analogues detemir or glargine during pregnancy in women with type 1 diabetes: comparison of glycaemic control and pregnancy outcome. J Matern Fetal Neonatal Med 2013;26(6):588-92
   PubMed Web of Science ®Google Scholar
• Lapolla A, Di Cianni G, Bruttomesso D, et al. Use of insulin detemir in pregnancy: a report on 10 type 1 diabetic women. Diabet Med 2009;26(11):1181-2
   PubMedGoogle Scholar
• Shenoy VV, Cook SJ, Parry AF, et al. Audit of insulin detemir in pregnancy: a retrospective case series. Diabet Med 2012;29(7):958-9
   PubMed Web of Science ®Google Scholar
• Sciacca L, Marotta V, Insalaco F, et al. Use of insulin detemir during pregnancy. Nutr Metab Cardiovasc Dis 2010;20(4):e15-16
   PubMedGoogle Scholar
• Pedersen-Bjergaard U, Kristensen PL, Beck-Nielsen H, et al. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial. Lancet Diabetes Endocrinol 2014;2(7):553-61
   PubMed Web of Science ®Google Scholar
• Haukka J, Hoti F, Erasto P, et al. Evaluation of the incidence and risk of hypoglycemic coma associated with selection of basal insulin in the treatment of diabetes: a Finnish register linkage study. Pharmacoepidemiol Drug Saf 2013;22(12):1326-35
   PubMed Web of Science ®Google Scholar
• Cavicchia PP, Liu J, Adams SA, et al. Proportion of gestational diabetes mellitus attributable to overweight and obesity among non-hispanic black, non-hispanic white, and hispanic women in South Carolina. Matern Child Health J 2014;18(8):1919-26
   PubMed Web of Science ®Google Scholar
• Haak T, Tiengo A, Draeger E, et al. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obes Metab 2005;7(1):56-64
   PubMed Web of Science ®Google Scholar
• Yale JF, Damci T, Kaiser M, et al. Initiation of once daily insulin detemir is not associated with weight gain in patients with type 2 diabetes mellitus: results from an observational study. Diabetol Metab Syndr 2013;5(1):56
   PubMedGoogle Scholar