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New Insulin Formulations

New Insulin Formulations. Guillermo Umpierrez, MD, FACP, FACE Professor of Medicine Emory University School of Medicine Part 1. BANTING-1891-1941 & BEST-1899-1978. First commercial insulin. Milestones in Insulin Development. Insulin lispro approved in US (1996).

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New Insulin Formulations

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  1. New Insulin Formulations Guillermo Umpierrez, MD, FACP, FACE Professor of Medicine Emory University School of Medicine Part 1

  2. BANTING-1891-1941 & BEST-1899-1978 First commercial insulin

  3. Milestones in Insulin Development Insulin lispro approved in US (1996) Synthetic human insulin developed (1965) Insulin discovered (1921) Insulin detemir approved in US(2005) Recombinant human insulin developed (1979) NPH insulin developed (1946) Inhaled insulin (2006) 2014 Degludec (2013) 1920 1930 1940 1950 1960 1970 1980 1990 2000 2010 2013 2014 In development: Degludec U-200 Glargine U-300 Pegylated Lispro Biosimilars Insulin pen developed (1981) Lente (zinc) insulins developed (1952) Insulin glulisine (2004) Insulin pump developed (1978?) Protamine and protamine zinc insulins developed (1936) Insulin aspart and insulin glargine approved in US (2000) First human treatment with bovine insulin (1922) Tattersall RB. In: Pickup JC, Williams G, eds. Textbook of Diabetes. 3rd ed. Blackwell Science: Malden, MA; 2003:1.1-1.22; Drugs@ FDA; http://diabetes.webmd.com/news/20071018/pfizer-quits-inhaled-insulin-exubera.

  4. Currently Available Basal Insulins Lucidi D, et al. Diabetes Care. 2011;34:1312-1314. Niswender K, et al. Clin Diabetes. 2009;27:60-68.

  5. 10 9 8 FPG (mmol/l) 7 6 5 0 4 8 12 16 20 24 Time (weeks) Insulin Glargine vs NPH Insulin Added to Oral Therapy: FPG and HbA1c 756 patients previously treated with 1―2 OHAs and HbA1c >7.5% Mean daily insulin dose Insulin glargine: 47 units NPH: 42 units Insulin glargine NPH 9 8 HbA1c (%) 7 6 0 4 8 12 16 20 24 Time (weeks) Riddle M, et al. Diabetes Care 2003;26:3080−6.

  6. Treat to Target Trial: Frequency of Hypoglycemia 900 800 Glargine 41% RRR P <0.003 700 NPH 600 500 Cumulative number of events Documented PG< 56 mg/dL (3.1 mmol/L) NPH 400 300 Glargine 200 100 0 0 24 48 72 96 120 144 168 Time (days) Riddle MC, et al. Diabetes Care. 2003;26:3080-3086

  7. 29 trials, with 17,588 patients HbA1c < 7% was achieved in 41.4% (95% CI, 35.6–47.4%). First insulin treatment, lower insulin and use of 2 oral drugs were predictors of response. Hypoglycemia ranged from 0 to 4.71 events/patient/30 days Weight gain ~1.75 kg HbA1c < 7% was achieved in 41.4% (95% CI, 35.6–47.4%) Giugliano et al. Diabetes Research & Clinical Practice 92 (2011) 1–10

  8. Available Premixed/Biphasic Insulins American Diabetes Association. Practical Insulin: A Handbook for Prescribing Providers. 3rd ed. 2011:1-68. NPH, neutral protamine Hagedorn; NPL, neutral protamine lispro suspension.

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