Biphasic vs basal bolus insulin regimen in Type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials

Diabetic Medicine

Volumn 32, Issue 5, 2015, Pages 585-594

  Wang, C ^a   Mamza, J ^a   Idris, I ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BASAL BOLUS INSULIN; BIPHASIC INSULIN; HEMOGLOBIN A1C; INSULIN ASPART; INSULIN DERIVATIVE; INSULIN DETEMIR; INSULIN GLARGINE; INSULIN GLULISINE; INSULIN LISPRO; ISOPHANE INSULIN; PIG INSULIN; UNCLASSIFIED DRUG; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; INSULIN;

ARTICLE; BODY MASS; BODY WEIGHT; CLINICAL EVALUATION; DIABETIC PATIENT; DRUG EFFICACY; EMBASE; GLYCEMIC CONTROL; HIGH RISK PATIENT; HUMAN; INSULIN HYPOGLYCEMIA; INSULIN TREATMENT; INTERVENTION STUDY; MEDLINE; META ANALYSIS; NON INSULIN DEPENDENT DIABETES MELLITUS; NORMAL VALUE; PATIENT RISK; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SCOPUS; SYSTEMATIC REVIEW; TREATMENT OUTCOME; WEIGHT GAIN; BLOOD; COMPARATIVE STUDY; DIABETES MELLITUS, TYPE 2; DOSE RESPONSE; DRUG ADMINISTRATION; GLUCOSE BLOOD LEVEL; HYPOGLYCEMIA; METABOLISM; MIDDLE AGED; PATHOPHYSIOLOGY; PHYSIOLOGY; RISK FACTOR;

BIPHASIC INSULINS; BLOOD GLUCOSE; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; MIDDLE AGED; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS; TREATMENT OUTCOME;

EID: 84928054129     PISSN: 07423071     EISSN: 14645491     Source Type: Journal    
DOI: 10.1111/dme.12694     Document Type: Article

References (40)

1. DeWitt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA 2003; 289: 2254-2264.
2. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. New Engl J Med 1993; 329: 977-986.
3. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-Year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008; 359: 1577-1589.
4. Garber AJ. Methods to enhance delivery of prandial insulin and basal-prandial insulin. Diabetes Obes Metab 2013; 15(Suppl 1): 11-17.
5. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R et al. Medical management of hyperglycemia in type 2 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.
6. Hamaty M. Insulin treatment for type 2 diabetes: when to start, which to use. Cleve Clin J Med 2011; 78: 332-342.
7. Peyrot M, Rubin RR, Kruger DF, Travis LB. Correlates of insulin injection omission. Diabetes Care 2010; 33: 240-245.
8. Turner HE, Matthews DR. The use of fixed-mixture insulins in clinical practice. Eur J Clin Pharmacol 2000; 56: 19-25.
9. Type 2 Diabetes: newer agents [article online], 2009. Available at http://www.nice.org.uk/nicemedia/live/12165/44318/44318.pdf. Last accessed 19 July 2013.
10. National Institute for Health and Clinical Excellence. The Guidelines Manual. London: NICE, 2012.
11. Elbourne DR, Altman DG, Higgins JPT, Curtin F, Worthington HV, Vail A. Meta-analyses involving cross-over trials: methodological issues. Int J Epidemiol 2002; 31: 140-149.
12. Higgins JPT, Altman DG, Sterne JAC (Eds). Cochrane Handbook for Systematic Reviews of Interventions, Version 5.1.0 [updated March 2011], Chapter 8. The Cochrane Collaboration, 2011.
13. Coster S, Gulliford MC, Seed PT, Powrie JK, Swaminathan R. Monitoring blood glucose control in diabetes mellitus: a systematic review. Health Technology Assessment 2000; 4: i-iv, 1-93.
14. Frison L, Pocock SJ. Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med 1992; 11: 1685-1704.
15. Kloos C, Samann A, Lehmann T, Braun A, Heckmann B, Muller UA. Flexible intensive versus conventional insulin therapy in insulin-naive adults with type 2 diabetes: an open-label, randomized, controlled, crossover clinical trial of metabolic control and patient preference. Diabetes Care 2007; 30: 3031-3032.
16. Miser WF, Arakaki R, Jiang H, Scism-Bacon J, Anderson PW, Fahrbach JL. Randomized, open-label, parallel-group evaluations of basal-bolus therapy versus insulin lispro premixed therapy in patients with type 2 diabetes mellitus failing to achieve control with starter insulin treatment and continuing oral antihyperglycemic drugs: a noninferiority intensification substudy of the DURABLE trial. Clin Ther 2010; 32: 896-908.
17. Buse JB, Wolffenbuttel BHR, Herman WH, Shemonsky NK, Jiang HH, Fahrbach JL et al. DURAbility of basal versus lispro mix 75/25 insulin efficacy (DURABLE) trial 24-week results:safety and efficacy of insulin lispro mix 75/25 versus insulin glargine added to oral antihyperglycemic drugs in patients with type 2 diabetes. Diabetes Care 2009; 32: 1007-1013.
18. Liebl A, Prager R, Binz K, Kaiser M, Bergenstal R, Gallwitz B et al. 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.
19. Bowering K, Reed VA, Felicio JS, Landry J, Ji L, Oliveira J. A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet Med 2012; 29: e263-272.
20. Fritsche A, Larbig M, Owens D, Haring HU. Comparison between a basal-bolus and a premixed insulin regimen in individuals with type 2 diabetes-results of the GINGER study. Diabetes Obes Metab 2010; 12: 115-123.
21. 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 type 2 diabetes. Diabetes Obes Metab 2010; 12: 967-975.
22. Levin PA, Zhang Q, Mersey JH, Lee FY, Bromberger LA, Bhushan M et al. Glycemic control with insulin glargine plus insulin glulisine versus premixed insulin analogues in real-world practices: a cost-effectiveness study with a randomized pragmatic trial design. Clin Ther 2011; 33: 841-850.
23. 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 type 2 diabetes. Exp Clin Endocrinol Diabetes 2006; 114: 511-519.
24. Shanmugasundar G, Bhansali A, Walia R, Dutta P, Upreti V. Comparison of thrice daily biphasic human insulin (30/70) versus basal detemir & bolus aspart in patients with poorly controlled type 2 diabetes mellitus - a pilot study. Indian J Med Res 2012; 135: 78-83.
25. Hirao K, Arai K, Yamauchi M, Takagi H, Kobayashi M. Six-month multicentric, open-label, randomized trial of twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart in Japanese type 2 diabetic patients (JDDM 11). Diabetes Res Clin Pract 2008; 79: 171-176.
26. Masuda H, Sakamoto M, Irie J, Kitaoka A, Shiono K, Inoue G et al. Comparison of twice-daily injections of biphasic insulin lispro and basal-bolus therapy: glycaemic control and quality-of-life of insulin-naïve type 2 diabetic patients. Diabetes Obes Metab 2008; 10: 1261-1265.
27. Yazici D, Tas S, Emir H, Sunar H. A comparison of preprandial mixed insulin given three times daily and basal-bolus insulin therapy started postoperatively on patients having coronary artery bypass graft surgery [Koroner arter bypass cerrahisi geciren hastalarda 3'lu kari{dotless}si{dotless}m ve 4'lu yogun insulin tedavilerinin karsi{dotless}lasti{dotless}ri{dotless}lmasi{dotless}]. Marmara Med J 2012; 25: 16-19.
28. Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 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.
29. EuroQol Group. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy (Amsterdam)1990; 16: 199-208.
30. Meadows KA, Abrams C, Sandbaek A. Adaptation of the Diabetes Health Profile (DHP-1) for use with patients with Type 2 diabetes mellitus: psychometric evaluation and cross-cultural comparison. Diabet Med 2000; 17: 572-580.
31. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics 1993; 4: 353-365.
32. Lasserson DS, Glasziou P, Perera R, Holman RR, Farmer AJ. Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses. Diabetologia 2009; 52: 1990-2000.
33. Siebenhofer A, Plank J, Berghold A, Jeitler K, Horvath K, Narath M et al. Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus. The Cochrane Database of Systematic Reviews, 2006: CD003287.
34. Idris I, Pillai A, Fernando DJ, Thomson G, Tate H. Responders to insulin therapy at 18 months in adults with newly diagnosed diabetes: which insulin regimen? Diabet Med 2013; 30: e95-100.
35. Owen V, Seetho I, Idris I. Predictors of responders to insulin therapy at 1 year among adults with type 2 diabetes. Diabetes Obes Metab 2010; 12: 865-870.
36. Holman RR, Farmer AJ, Davies MJ, Levy JC, Darbyshire JL, Keenan JF et al. Three-year efficacy of complex insulin regimens in type 2 diabetes. N Engl J Med 2009; 361: 1736-1744.
37. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabet Care 2003; 26: 1902-1912.
38. Testa MA, Gill J, Su M, Turner RR, Blonde L, Simonson DC. Comparative effectiveness of basal-bolus versus premix analog insulin on glycemic variability and patient-centered outcomes during insulin intensification in type 1 and type 2 diabetes: a randomized, controlled, crossover trial. J Clin Endocrinol Metab 2012; 97: 3504-3514.
39. Hanestas BR, Albreksten G. Quality of life, perceived difficulties in adherence to a diabetes regimen, and blood glucose control. Diabet Med 1991; 8: 759-764.
40. Zambanini A, Newson RB, Maisey M, Fehrer MD. Injection related anxiety in insulin-treated diabetes. Diabetes Res Clin Pract 1999; 46: 239-246.