The safety and efficacy of adding once-daily insulin detemir to oral hypoglycaemic agents in patients with type 2 diabetes in a clinical practice setting in 10 countries

Diabetes, Obesity and Metabolism

Volumn 14, Issue 12, 2012, Pages 1129-1136

  Khunti, Kamlesh ^a   Caputo, S ^b   Damci, T ^c   Dzida, G J ^d   Ji, Q ^e   Kaiser, M ^f   Karnieli, E ^g   Liebl, A ^h   Ligthelm, R J ⁱ   Nazeri, A ^j   Orozco Beltran, D ^k   Pan, C ^l   Ross, S A ^m   Svendsen, A L ^j   Vora, J ⁿ   Yale, J F ^o   Meneghini, L F ^p   Maran, A ^q   Raimundo, L ^q   Artola, S ^q   Imamoglu, S ^q   more..

^a UNIVERSITY OF LEICESTER   (United Kingdom)

^b FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

^c ISTANBUL UNIVERSITY   (Turkey)

^d MEDICAL UNIVERSITY OF LUBLIN   (Poland)

^e FOURTH MILITARY MEDICAL UNIVERSITY   (China)

^f Practice for Internal Medicine and Diabetology   (Germany)

^g TECHNION ISRAEL INSTITUTE OF TECHNOLOGY   (Israel)

^h Department for Internal Medicine Center for Diabetes and Metabolism M and i Fachklinik Bad Heilbrunn   (Germany)

ⁱ EHM Clinic   (Netherlands)

^j NOVO NORDISK A S   (Denmark)

^k MIGUEL HERNÁNDEZ UNIVERSITY   (Spain)

^l CHINESE PLA GENERAL HOSPITAL   (China)

^m UNIVERSITY OF CALGARY   (Canada)

ⁿ ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

^o ROYAL VICTORIA HOSPITAL   (Canada)

^p UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^q University of Miami Miller School of Medicine ^*

more..

Author keywords

Basal insulin; HbA1c; Hypoglycaemia; Metformin; Oral hypoglycaemic agent; Sulphonylurea; Type 2 diabetes mellitus

Indexed keywords

ALPHA GLUCOSIDASE INHIBITOR; BIGUANIDE; DIPEPTIDYL PEPTIDASE IV INHIBITOR; GLITAZONE DERIVATIVE; HEMOGLOBIN A1C; INSULIN; INSULIN DETEMIR; ORAL ANTIDIABETIC AGENT; SULFONYLUREA; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN; LONG ACTING INSULIN; BIGUANIDE DERIVATIVE; GLINIDE DERIVATIVE; SULFONYLUREA DERIVATIVE; UNCLASSIFIED DRUG;

ADD ON THERAPY; ADULT; AGED; ARTICLE; BODY MASS; CLINICAL PRACTICE; DIABETIC PATIENT; DISEASE DURATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; GLYCEMIC CONTROL; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INJECTION SITE REACTION; INSULIN BLOOD LEVEL; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OBSERVATIONAL STUDY; SKIN DISEASE; WEIGHT CHANGE; WEIGHT REDUCTION; ANALOGS AND DERIVATIVES; BLOOD; CANADA; CHINA; CLINICAL TRIAL; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION; DRUG COMBINATION; EUROPE; GLUCOSE BLOOD LEVEL; METABOLISM; MIDDLE AGED; TREATMENT OUTCOME; DEMOGRAPHY; DISEASE SEVERITY; DRUG DOSE TITRATION; DRUG WITHDRAWAL; EVENING DOSAGE; FOLLOW UP; GERMANY; ISRAEL; ITALY; MEDICAL DECISION MAKING; MORNING DOSAGE; OUTCOME ASSESSMENT; POLAND; PORTUGAL; RISK BENEFIT ANALYSIS; SPAIN; TREATMENT DURATION; TURKEY (REPUBLIC); UNITED KINGDOM; WEIGHT GAIN;

AGED; BLOOD GLUCOSE; BODY MASS INDEX; CANADA; CHINA; DIABETES MELLITUS, TYPE 2; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; EUROPE; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN, LONG-ACTING; MALE; MIDDLE AGED; TREATMENT OUTCOME;

EID: 84873248938     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/j.1463-1326.2012.01665.x     Document Type: Article

References (35)

1. Alvarez GF, Mavros P, Nocea G, Alemao E, Alexander CM, Yin D. Glycaemic control among patients with type 2 diabetes mellitus in seven European countries: findings from the real-life effectiveness and care patterns of diabetes management (RECAP-DM) study. Diabetes Obes Metab 2008; 10(Suppl. 1): 8-15.
2. Calvert MJ, McManus RJ, Freemantle N. Management of type 2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. Br J Gen Pract 2007; 57: 455-460.
3. Costi M, Dilla T, Reviriego J, Castell C, Goday A. Clinical characteristics of patients with type 2 diabetes mellitus at the time of insulin initiation: INSTIGATE observational study in Spain. Acta Diabetol 2010; 47: 169-175.
4. Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab 2011; 13: 268-275.
5. Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther 2006; 28: 1569-1581.
6. Fritsche A, Schweitzer MA, Haring HU. Glimepiride combined with morning insulin glargine, bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes. A randomized, controlled trial. Ann Intern Med 2003; 138: 952-959.
7. Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care 2005; 28: 1282-1288.
8. Holman RR, Thorne KI, Farmer AJ et al. Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med 2007; 357: 1716-1730.
9. Nathan DM, Buse JB, Davidson MB 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.
10. Meneghini L, Liebl A, Abrahamson MJ. Insulin detemir: a historical perspective on a modern basal insulin analogue. Prim Care Diabetes 2010; 4(Suppl. 1): S31-42.
11. Monami M, Marchionni N, Mannucci E. Long-acting insulin analogues versus NPH human insulin in type 2 diabetes: a meta-analysis. Diabetes Res Clin Pract 2008; 81: 184-189.
12. Giugliano D, Maiorino MI, Bellastella G, Chiodini P, Esposito K. Treatment regimens with insulin analogues and haemoglobin A1c target of <7% in type 2 diabetes: a systematic review. Diabetes Res Clin Pract 2011; 92: 1-10.
13. 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.
14. Swinnen SG, Simon AC, Holleman F, Hoekstra JB, Devries JH. Insulin detemir versus insulin glargine for type 2 diabetes mellitus. Cochrane Database Syst Rev 2011; 7: CD006383.
15. Kunt T, Snoek FJ. Barriers to insulin initiation and intensification and how to overcome them. Int J Clin Pract Suppl 2009; 164: 6-10.
16. Peyrot M, Rubin RR, Lauritzen T et al. Resistance to insulin therapy among patients and providers: results of the cross-national diabetes attitudes, wishes, and needs (DAWN) study. Diabetes Care 2005; 28: 2673-2679.
17. Gerstein HC, Miller ME, Genuth S et al. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med 2011; 364: 818-828.
18. Del Prato S. Megatrials in type 2 diabetes. From excitement to frustration? Diabetologia 2009; 52: 1219-1226.
19. Khunti K, Damci T, Meneghini LF, Pan CY, Yale J-F. Study of once-daily levemir (SOLVE): insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice. Diabetes Obes Metab 2012; 14: 654-661.
20. Donnelly LA, Morris AD, Frier BM et al. Frequency and predictors of hypoglycaemia in Type 1 and insulin-treated Type 2 diabetes: a populationbased study. Diabet Med 2005; 22: 749-755.
21. Murata GH, Duckworth WC, Shah JH, Wendel CS, Mohler MJ, Hoffman RM. Hypoglycemia in stable, insulin-treated veterans with type 2 diabetes: a prospective study of 1662 episodes. J Diabetes Complications 2005; 19: 10-17.
22. Akram K, Pedersen-Bjergaard U, Carstensen B, Borch-Johnsen K, Thorsteinsson B. Frequency and risk factors of severe hypoglycaemia in insulin-treated Type 2 diabetes: a cross-sectional survey. Diabet Med 2006; 23: 750-756.
23. Henderson JN, Allen KV, Deary IJ, Frier BM. Hypoglycaemia in insulintreated Type 2 diabetes: frequency, symptoms and impaired awareness. Diabet Med 2003; 20: 1016-1021.
24. Leese GP, Wang J, Broomhall J et al. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care 2003; 26: 1176-1180.
25. Miller ME, Bonds DE, Gerstein HC et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ 2010; 340: b5444.
26. UK Hypoglycaemia Study Group. Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration. Diabetologia 2007; 50: 1140-1147.
27. Hermansen K, Davies M, Derezinski T, Martinez RG, Clauson P, Home P. 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-naive people with type 2 diabetes. Diabetes Care 2006; 29: 1269-1274.
28. Rosenstock J, Dailey G, Massi-Benedetti M, Fritsche A, Lin Z, Salzman A. Reduced hypoglycemia risk with insulin glargine: a meta-analysis comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care 2005; 28: 950-955.
29. Kann PH, Wascher T, Zackova V et al. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes 2006; 114: 527-532.
30. Kennedy L, Herman WH, Strange P, Harris A. Impact of active versus usual algorithmic titration of basal insulin and point-of-care versus laboratory measurement of HbA1c on glycemic control in patients with type 2 diabetes: the glycemic optimization with algorithms and labs at point of care (GOAL A1C) trial. Diabetes Care 2006; 29: 1-8.
31. Dornhorst A, Luddeke HJ, Sreenan S et al. Insulin detemir improves glycaemic control without weight gain in insulin-naive patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract 2008; 62: 659-665.
32. Haak T, Tiengo A, Draeger E, Suntum M, Waldhausl W. Lower withinsubject 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: 56-64.
33. Raslova K, Tamer SC, Clauson P, Karl D. Insulin detemir results in less weight gain than NPH insulin when used in basal-bolus therapy for type 2 diabetes mellitus, and this advantage increases with baseline body mass index. Clin Drug Investig 2007; 27: 279-285.
34. Ligthelm RJ. Insulin analogues: how observational studies provide key insights into management of patients with type 2 diabetes mellitus. Curr Med Res Opin 2011; 27: 2343-2355.
35. Zammitt NN, Frier BM. Hypoglycemia in type 2 diabetes: pathophysiology, frequency, and effects of different treatment modalities. Diabetes Care 2005; 28: 2948-2961.