Efficacy and Safety of Insulin Glulisine in Patients with Type 1 Diabetes

Abstract

Insulin glulisine (glulisine), a human insulin analogue with a rapid-acting time-action profile, has been developed to fulfil the mealtime (bolus) insulin requirement in patients with diabetes. The aim of this multinational, multi-centre, controlled, open-label, randomized, parallel-group study was to compare the efficacy and safety of insulin glulisine (glulisine) to that of insulin lispro (lispro) in adults diagnosed with Type 1 diabetes. Of the 683 patients randomized, 672 received treatment (339 patients received glulisine, 333 patients received lispro). Over the 26-week study, a similar reduction in mean HbA_1c occurred in both groups (adjusted mean change from baseline - 0.14 % in both groups). The basal insulin dose was relatively unchanged from baseline in the glulisine group but increased in the lispro group (glulisine: 0.12 IU vs. lispro: 1.82 IU; p = 0.0001). As a consequence, total daily insulin dose decreased in the glulisine group but increased in the lispro group (glulisine: - 0.86 IU vs. lispro: 1.01 IU; p = 0.0123). There was no relevant difference between the two groups in the reporting of symptomatic hypoglycaemia (overall, nocturnal and severe). This study demonstrates that glulisine provides equivalent glycaemic control to lispro. The clinical relevance of any difference in total daily insulin dose remains to be established.

Key words

Diabetes mellitus - rapid-acting insulin analogues - glycaemic control

References

• 1 DCCT . The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group.  N Engl J Med. 1993;  329 977-986
• 2 Heinemann L, Weyer C, Rauhaus M, Heinrichs S, Heise T. Variability of the metabolic effect of soluble insulin and the rapid-acting insulin analog insulin aspart.  Diabetes Care. 1998;  21 1910-1914
• 3 Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Di Vincenzo A, Cordoni C, Costa E, Brunetti P, Bolli G B. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro.  Diabetes. 2000;  49 2142-2148
• 4 Becker R, Frick A, Wessels D, Scholtz H E. Evaluation of the pharmacodynamic and pharmacokinetic profiles of insulin glulisine - a novel, rapid-acting, human insulin analogue.  Diabetologia. 2003;  46 Abs 775
• 5 Frick A, Becker R, Wessels D, Scholtz H E. Pharmacokinetic and glucodynamic profiles of insulin glulisine: an evaluation following subcutaneous administration at various injection sites.  Diabetologia. 2003;  46 Abs 776
• 6 Lalli C, Ciofetta M, Del Sindaco P, Torlone E, Pampanelli S, Campagnucci P, Cartechini M G, Bartocci L, Brunetti P, Bolli G B. Long-term intensive treatment of type 1 diabetes with the short-acting insulin analog lispro in variable combination with NPH insulin at mealtime.  Diabetes Care. 1999;  22 468-477
• 7 Raskin P, Guthrie R A, Leiter L, Riss A, Jovanic L. Use of insulin aspart, a fast-acting insulin analog, as the mealtime insulin in the management of patients with Type 1 diabetes.  Diabetes Care. 2000;  23 583-588
• 8 Kroon K. Chapter 13: Insulin - pharmacology, types of regimens and adjustments.  http://www.endotext.com. Accessed in October 2003
• 9 Frick A, Burger F, Scholz H, Becker R HA. Time-action profile of insulin glulisine versus regular human insulin and insulin lispro in obese subjects.  Diabetes. 2004;  52 (Suppl 2) A124 (Abstract 526-P)