A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: Results of the PARADIGM study

Diabetic Medicine

Volumn 29, Issue 9, 2012, Pages

  Bowering, K ^a   Reed, V A ^b   Felicio, J ^c   Landry, J ^d   Ji, L ^e   Oliveira, J ^d  

^a UNIVERSITY OF ALBERTA   (Canada)

^b ELI LILLY AUSTRALIA PTY LTD   (Australia)

^c FEDERAL UNIVERSITY OF PARÁ   (Brazil)

^d ELI LILLY AND COMPANY   (United States)

^e PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

Author keywords

Clinical trial; Insulin mixtures; Type2 diabetes

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN GLARGINE; INSULIN GLARGINE PLUS INSULIN LISPRO; INSULIN LISPRO; ORAL ANTIDIABETIC AGENT; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BEDTIME DOSAGE; CLINICAL TRIAL; DRUG DOSE TITRATION; DRUG SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; INSULIN HYPOGLYCEMIA; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; POSTPRANDIAL STATE; PROSPECTIVE STUDY; RANDOMIZATION; WEIGHT CHANGE;

ADMINISTRATION, ORAL; AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN LISPRO; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PROSPECTIVE STUDIES; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 84865124273     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2012.03722.x     Document Type: Article

References (16)

1. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type2 diabetes. N Engl J Med 2008; 359: 1577-1589.
2. Turnbull FM, Abraira C, Anderson RJ, Byington RP, Chalmers JP, Duckworth WC et al. Intensive glucose control and macrovascular outcomes in type2 diabetes. Diabetologia 2009; 52: 2288-2298.
3. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R et al. Medical management of hyperglycemia in type2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193-203.
4. Rodbard HW, Jellinger PS, Davidson JA, Einhorn D, Garber AJ, Grunberger G et al. Statement by an American Association of Clinical Endocrinologists/American College of Endocrinology consensus panel on type2 diabetes mellitus: an algorithm for glycemic control. Endocr Pract 2009; 15: 540-559.
5. Garber AJ, Ligthelm R, Christiansen JS, Liebl A. Premixed insulin treatment for type2 diabetes: analogue or human? Diabetes Obes Metab 2007; 9: 630-639.
6. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B, PREFER Study Group. Comparison of insulin analogue regimens in people with type2 diabetes mellitus in the PREFER Study: a randomized controlled trial. Diabetes Obes Metab 2009; 11: 45-52.
7. Jain SM, Mao X, Escalante-Pulido M, Vorokhobina N, Lopez I, Ilag LL. Prandial-basal insulin regimens plus oral antihyperglycaemic agents to improve mealtime glycaemia: initiate and progressively advance insulin therapy in type2 diabetes. Diabetes Obes Metab 2010; 12: 967-975.
8. Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C 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 type2 diabetes. Exp Clin Endocrinol Diabetes 2006; 114: 511-519.
9. Ilag LL, Kerr L, Malone JK, Tan MH. Prandial premixed insulin analogue regimens versus basal insulin analogue regimens in the management of type2 diabetes: an evidence-based comparison. Clin Ther 2007; 29: 1254-1270.
10. Christiansen JS, Liebl A, Davidson JA, Ligthelm RJ, Halimi S. Mid- and high-ratio premix insulin analogues: potential treatment options for patients with type2 diabetes in need of greater postprandial blood glucose control. Diabetes Obes Metab 2010; 12: 105-114.
11. Qayyum R, Bolen S, Maruthur N, Feldman L, Wilson LM, Marinopoulos SS et al. Systematic review: comparative effectiveness and safety of premixed insulin analogues in type2 diabetes. Ann Intern Med 2008; 149: 549-559.
12. Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care 2008; 31: 20-25.
13. Garber AJ, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E. et al. Attainment of glycaemic goals in type2 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.
14. World Medical Association Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. J Am Med Assoc 1997; 277: 925-926.
15. WHO. Definition and Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemia: Report of a WHO/IDF Consultation. Geneva: World Health Organization, 2006.
16. Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF et al. Three-year efficacy of complex insulin regimens in type2 diabetes. N Engl J Med 2009; 361: 1736-1747.