Hypoglycaemia with insulin aspart: A double-blind, randomised, crossover trial in subjects with Type 1 diabetes

Diabetic Medicine

Volumn 21, Issue 7, 2004, Pages 769-775

  Heller, S R ^a   Colagiuri, S ^b   Vaaler, S ^c   Wolffenbuttel, B H R ^d   Koelendorf, K ^e   Friberg, H H ^f   Windfeld, K ^f   Lindholm, A ^g  

^a NORTHERN GENERAL HOSPITAL   (United Kingdom)

^b PRINCE OF WALES HOSPITAL   (Australia)

^c Solli Klinikk ^*  (Norway)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^e KØGE HOSPITAL   (Denmark)

^f NOVO NORDISK A S   (Denmark)

^g Novo Nordisk Ltd   (United Kingdom)

Author keywords

Clinical trial; Double blind; Hypoglycaemia; Insulin aspart; Type 1 diabetes

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN ASPART; ISOPHANE INSULIN; NEUTRAL INSULIN;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE CONTROL; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; HYPOGLYCEMIA; INJECTION; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; MEAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ADULT; AGED; BLOOD GLUCOSE; CIRCADIAN RHYTHM; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN, ISOPHANE; MALE; MIDDLE AGED;

EID: 3142697942     PISSN: 07423071     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1464-5491.2004.01244.x     Document Type: Article

References (23)

1. Lindholm A, McEwen J, Riis AP. Improved postprandial glycaemic control with insulin aspart. A randomized double-blind cross-over trial in type 1 diabetes. Diabetes Care 1999; 22: 801-805.
2. Home PD, Lindholm A, Riis A. Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trial. Diabet Med 2000; 17: 762-770.
3. Bonora E, Muggeo M. Postprandial blood glucose as a risk factor for cardiovascular disease in Type II diabetes: the epidemiological evidence. Diabetologia 2001; 44: 2107-2114.
4. Brunelle RL, Llewelyn J, Anderson JH, Gale EAM, Koivisto VA. Meta-analysis of the effect of insulin lispro on severe hypoglycaemia in patients with type 1 diabetes. Diabetes Care 1998; 21: 1726-1731.
5. Raskin P, Guthrie RA, Leiter L, Riis A, Jovanovic L. Use of insulin aspart, a fast-acting insulin analogue, as the mealtime insulin in the management of patients with type 1 diabetes. Diabetes Care 2000; 23: 583-588.
6. Lalli C, Ciofetta M, Del Sindaco P, Torlone E, Pampanelli S, Compagnucci P et al. Long-term intensive treatment of type 1 diabetes with the short-acting insulin analogue lispro in variable combination with NPH insulin at mealtime. Diabetes Care 1999; 22: 468-477.
7. Del Sindaco P, Ciofetta M, Lalli C, Perriello G, Pampanelli S, Torlone E et al. Use of the short-acting insulin analogue lispro in intensive treatment of type 1 diabetes mellitus: importance of appropriate replacement of basal insulin and time-interval injection-meal. Diabet Med 1998; 15: 592-600.
8. Heller SR, Amiel SA, Mansell P. Effect of the fast-acting insulin analogue lispro on the risk of nocturnal hypoglycaemia during intensified insulin therapy. UK Lispro Study Group. Diabetes Care 1999; 22: 1607-1611.
9. Holleman F, Schmitt H, Rottiers R, Rees A, Symanowski S, Anderson JH. Reduced frequency of severe hypoglycaemia and coma in well-controlled IDDM patients treated with insulin lispro. The Benelux-UK Insulin Lispro Study Group. Diabetes Care 1997; 20: 1827-1832.
10. Overmann H, Heinemann L. Injection-meal interval: recommendations of diabetologists and how patients handle it. Diabetes Res Clin Pract 1999; 43: 137-142.
11. Heinemann L. Do insulin-treated diabetic patients use an injection-meal-interval in daily life? Diabet Med 1995; 12: 449-450.
12. Home PD, Lindholm A, Hylleberg B, Round P. Improved glycaemic control with insulin aspart: a multicenter randomized double-blind crossover trial in type 1 diabetic patients. UK Insulin Aspart Study Group. Diabetes Care 1998; 21: 1904-09.
13. Wald A, Wolfowitz J. On a test whether two samples are from the same population. Ann Math Stat 1940; 11: 147-162.
14. Hills M, Armitage P. The two-period cross-over clinical trial. Br J Clin Pharmacol 1979; 8: 7-20.
15. Lindholm A, Andersen HF, Hylleberg B, Gall M. A review of the safety profile of insulin aspart. Diabetologia 2000; 43: A199.
16. Pfützner A, Küstner E, Forst T, Schulze-Schleppinghoff B, Trautmann ME, Haslbeck M et al. Intensive insulin therapy with insulin lispro in patients with type 1 diabetes reduces the frequency of hypoglycaemic episodes. Exp Clin Endocrinol Diabetes 1996; 104: 25-30.
17. Anderson JH, Brunelle RL, Koivisto VA, Pfutzner A, Trautmann ME, Vignati L et al. Reduction of postprandial hyperglycaemia and frequency of hypoglycaemia in IDDM patients on insulin-analogue treatment. Diabetes 1997; 46: 265-270.
18. Gale EA. A randomized, controlled trial comparing insulin lispro with human soluble insulin in patients with Type 1 diabetes on intensified insulin therapy. The UK Trial Group. Diabet Med 2000; 17: 209-214.
19. Tamborlane WV, Bonfig W, Boland E. Recent advances in treatment of youth with Type 1 diabetes: better care through technology. Diabet Med 2001; 18: 864-870.
20. Heinemann L. Hypoglycaemia and insulin analogues: Is there a reduction in the incidence? J Diabetes Complications 1999; 13: 105-114.
21. Torlone E, Pampanelli S, Lalli C, Del Sindaco P, Di Vincenzo A, Rambotti AM et al. Effects of the short-acting insulin analogue [Lys (B28), Pro (B29)] on postprandial blood glucose control in IDDM. Diabetes Care 1996; 19: 945-952.
22. Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA. Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. Diabetes Care 2000; 23: 639-643.
23. Brunner GA, Sendlhofer G, Wutte A, Ellmerer M, Soegaard B, Siebenhofer A et al. Pharmacokinetic and pharmacodynamic properties of long-acting insulin analogue NN304 in comparison to NPH insulin in humans. Exp Endocrinol Diabetes 2000; 108: 100-105.