A 26-week, randomized, parallel, treat-to-target trial comparing insulin detemir with NPH insulin as add-on therapy to oral glucose-lowering drugs in insulin-Naïve people with type 2 diabetes

Diabetes Care

Volumn 29, Issue 6, 2006, Pages 1269-1274

  Hermansen, Kjeld ^a   Davies, Melanie ^b   Derezinski, Taudeusz ^c   Ravn, Gabrielle Martinez ^d   Clauson, Per ^d   Home, Philip ^e  

^a AARHUS UNIVERSITY HOSPITAL   (Denmark)

^b LEICESTER ROYAL INFIRMARY   (United Kingdom)

^c Outpatient Clinic   (Poland)

^d NOVO NORDISK A S   (Denmark)

^e NEWCASTLE UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA GLUCOSIDASE INHIBITOR; INSULIN DERIVATIVE; INSULIN DETEMIR; ISOPHANE INSULIN; METFORMIN;

ADD ON THERAPY; ADULT; ALLERGY; ARTICLE; BODY WEIGHT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG PROTEIN BINDING; DRUG TOLERABILITY; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HEMATOMA; HUMAN; HYPOGLYCEMIA; INJECTION SITE IRRITATION; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; TITRIMETRY; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; WEIGHT GAIN;

ADMINISTRATION, ORAL; ADULT; BLOOD GLUCOSE; BODY MASS INDEX; BODY WEIGHT; DIABETES MELLITUS, TYPE 2; DRUG THERAPY, COMBINATION; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN, ISOPHANE; WEIGHT GAIN;

EID: 33746391488     PISSN: 01495992     EISSN: 01495992     Source Type: Journal    
DOI: 10.2337/dc05-1365     Document Type: Article

References (38)

1. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR: Association of glycemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ 321:405-411, 2000
2. Gaster B, Hirsch IB: The effects of improved glycemic control on complications in type 2 diabetes. Arch Intern Med 158:134-140, 1998
3. Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M: Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract 28:103-117, 1995
4. Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O: Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med 348:383-393, 2003
5. IDF Clinical Guidelines Task Force: Global guideline for type 2 diabetes [article online]. Brussels, International Diabetes Federation, 2005. Available at http://www.idf.org. Accessed 1 August 2005
6. Koro CE, Bowlin SJ, Bourgeois N, Fedder DO: Glycemic control from 1988 to 2000 among U.S. adults diagnosed with type 2 diabetes. Diabetes Care 27:17-20, 2004
7. Turner RC, Cull CA, Frighi V, Holman RR, the UK Prospective Diabetes Study Group: Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA 281:2005-2012, 1999
8. Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS: Racial and ethnic differences in glycemic control in adults with type 2 diabetes. Diabetes Care 22:403-408, 1999
9. Davies M: The reality of glycaemic control in insulin treated diabetes: defining the clinical challenges. Int J Obes Relat Metab Disord 28 (Suppl. 2):S14-S22, 2004
10. McCrimmon RJ, Frier BM: Hypoglycemia, the most feared complication of insulin therapy. Diabete Metab 20:503-512, 1994
11. Korytkowski M: When oral agents fail: practical barriers to starting insulin. Int J Obes 26:S18-S24, 2002
12. Heinemann L: Overcoming obstacles: new management options. Eur J Endocrinol 151:T023-T027, 2004
13. Wright A, Burden ACF, Paisey RB, Cull CA, Holman RR, the U.K. Diabetes Study Group: Sulfonylurea inadequacy: efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57). Diabetes Care 25:330-336, 2002
14. Riddle MC, Rosenstock J, Gerich J, the Insulin Glargine 4002 Study Investigators: The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 26:3080-3086, 2003
15. Havelund S, Plum A, Ribel U, Jonassen I, Volund A, Markussen J, Kurtzhals P: The mechanism of protraction of insulin detemir, a long-acting, acylated analog of human insulin. Pharm Res 21:1498-1504, 2004
16. Heise T, Nosek L, Ronn BB, Endahl L, Heinemann L, Kapitza C, Draeger E: Lower within-subject variability of insulin detemir in comparison to NPH insulin and insulin glargine in people with type 1 diabetes. Diabetes 53:1614-1620, 2004
17. Kurtzhals P: Engineering predictability and protraction in a basal insulin analogue: the pharmacology of insulin detemir. Int J Obes Relat Metab Disord 28 (Suppl. 2):S23-S28, 2004
18. Standl E, Lang H, Roberts A: The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy for the treatment of type 1 diabetes. Diabetes Technol Ther 6:579-588, 2004
19. Vague P, Selam JL, Skeie S, De Leeuw I, Elte JW, Haahr H, Kristensen A, Draeger E: Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 26:590-596, 2003
20. De Leeuw I, Selam J-S, Skeie S, Elte JWF, Lang H, Vague P: Insulin detemir-based used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycemia and less weight gain over 12 months in comparison to NPH insulin. Diabetes Obesity and Metabolism 7:73-83, 2005
21. Home P, Bartley P, Russell-Jones D, Hanaire-Broutin H, Heeg JE, Abrams P, Landin-Olsson M, Hylleberg B, Lang H, Draeger E, Study to Evaluate the Administration of Insulin Detemir Insulin Efficacy, Safety and Suitability (STEADINESS) Study Group: Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care 27:1081-1087, 2004
22. Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J: Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther 26:724-736, 2004
23. Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA: 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 47:622-629, 2004
24. Raslova K, Bogoev M, Raz I, Leth G, Gall MA, Hancu N: Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes. Diabetes Res Clin Pract 66:193-201, 2004
25. Haak T, Tiengo A, Draeger E, Suntum M, Waldhäusl W: 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 7:56-65, 2005
26. Moher D, Schulz KF, Altman DG, the CONSORT Group: Revised recommendations for improving the quality of reports of parallel group randomized trials 2001 [article online]. Available at http://www.consort-statement.org/statement/ revisedstatement.htm. Accessed 20 April 2001
27. 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. Lancet 352:837-853, 1998
28. YKI-Järvinen H, Dressler A, Ziemen M, the HOE 901/3002 Study Group: Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. Diabetes Care 23:1130-1136, 2000
29. Ryssy L, Yki-Järvinen H, Hänninen J, Hulme S, Kauppinen-Mäkelin R, Landenperä S, et al.: Simplifying treat to target: the LANMET study. Diabetologia 47 (Suppl. 1):A271, 2004
30. Raslova K, Bogoev M, Raz I, Leth G, Gall MA, Hancu N: Insulin detemir and insulin aspart: a promising basal-bolus regimen for type 2 diabetes Diabetes Res Clin Pract 66:193-201, 2004
31. Riddle M: Evening insulin strategy. Diabetes Care 13:676-686, 1990
32. 1c. Diabetes Care 26:881-885, 2003
33. Riddle M, Arbet-Engels C, Nguyen HH: Differences in HbA1c levels between insulin glargine and NPH insulin at equivalent incidences of hypoglycemia in patients with type 2 diabetes (Abstract). Endocr Pract 10 (Suppl. 1):48, 2004
34. Gumbiner B, Battiwalla M: Obesity and type 2 diabetes mellitus: a treatment challenge. Endocrinologist 12:23-28, 2002
35. Purnell JQ, Hokanson JE, Marcovina SM, Steffes MW, Cleary PA, Brunzell JD: Effect of excessive weight gain with intensive therapy of type 1 diabetes on lipid levels and blood pressure: results from the DCCT. J Am Med Assoc 280:140-146, 1998
36. Palmer AJ, Roze S, Valentine WJ, Minshall ME, Lammert M, Nicklasson L, Spinas GA: Deleterious effects of increased body weight associated with intensive insulin therapy for type 1 diabetes: increased blood pressure and worsened lipid profile partially negate improvements in life expectancy. Curr Med Res Opin 20 (Suppl. 1):S67-S73, 2004
37. Fritsche A, Haring H: At last, a weight neutral insulin? Int J Obes Relat Metab Disord 28 (Suppl. 2):S41-S46, 2004
38. Hordern SV, Wright JE, Umpleby AM, Shojaee-Moradie F, Amiss J, Russell-Jones DL: Comparison of the effects on glucose and lipid metabolism of equipotent doses of insulin detemir and NPH insulin with a 16-h euglycaemic clamp. Diabetologia 48:420-426, 2005