Exp Clin Endocrinol Diabetes 2004; 112(6): 310-314
DOI: 10.1055/s-2004-820908
Article

J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York

The Addition of Acarbose to Insulin Lispro Reduces Acute Glycaemic Responses in Patients with Type-2 Diabetes

N. Hermanns1 , A. Burkert1 , T. Haak1
  • 1Research Institute of the Diabetes Academy Bad Mergentheim (FIDAM), Bad Mergentheim, Germany
Further Information

Publication History

Received: April 24, 2003 First decision: August 18, 2003

Accepted: October 30, 2003

Publication Date:
24 June 2004 (online)

Abstract

This double-blind, placebo-controlled single-centre cross-over study assessed the efficacy of acarbose as adjunct to insulin lispro therapy in avoiding postprandial blood glucose rise. A total of 30 type 2 diabetic patients currently treated with insulin were included. On two consecutive days subjects received a standardised breakfast (covered by insulin lispro) and were randomly assigned study medication of either 100 mg acarbose or matching placebo. Basal and prandial insulin doses were maintained during the study period. A total of nine blood samples (for parameter assessment) were taken at 30-minute intervals. Primary efficacy variables were the difference in blood glucose rise from fasting to 90 min after breakfast between acarbose/lispro and lispro monotherapy and the difference in the postprandial glucose profile (area under the curve, 0 - 240 min). Secondary parameters consisted of differences in postprandial C-peptide, insulin and triglyceride time profiles between the two treatments. Acarbose treatment significantly reduced the rise in 90 min postprandial blood glucose (1.95 ± 1.85 mmol/l) by more than half the increase observed under lispro monotherapy (4.37 ± 2.13 mmol/l; p = 0.000). Postprandial blood glucose, C-peptide and serum insulin levels (AUC0 - 240 min) all significantly improved under acarbose treatment. Triglyceride levels were not affected by the combination therapy.

Rapid-acting insulin lispro was efficiently complemented by the different mechanism of action of acarbose resulting in significant improvements of postprandial hyperglycaemia and the insulin profile.

References

  • 1 American College of Endocrinology . Consensus statement on guidelines for glycemic control.  Endocr Pract. 2002;  8 (Suppl 1) 5-11
  • 2 American Diabetes Association . Postprandial blood glucose.  Diabetes Care. 2001;  24 775-778
  • 3 Anderson Jr J H, Brunelle R L, Keohane P, Koivisto V A, Trautmann M E, Vignati L, DiMarchi R. Mealtime treatment with insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non-insulin-dependent diabetes mellitus.  Arch Intern Med. 1997;  157 1249-1255
  • 4 Barrett-Connor E, Ferrara A. Isolated postchallenge hyperglycemia and the risk of fatal cardiovascular disease in older women and men. The Rancho Bernardo Study.  Diabetes Care. 1998;  21 1236-1239
  • 5 Bland M. An Introduction to Medical Statistics. 3rd. ed. Oxford; Oxford University Press 2000
  • 6 Ceriello A. The post-prandial state and cardiovascular disease: relevance to diabetes mellitus.  Diabetes Metab Res Rev. 2000;  16 125-132
  • 7 Chiasson J-L, Josse R G, Hunt J A, Palmason C, Rodger N W, Ross S A, Ryan E A, Tan M H, Wolever T M. The efficacy of acarbose in the treatment of patients with non-insulin-dependent diabetes mellitus.  Ann Intern Med. 1994;  121 928-935
  • 8 Coniff R F, Shapiro J A, Seaton T B, Hoogwerf B J, Hunt J A. A double-blind placebo-controlled trial evaluating the safety and efficacy of acarbose for the treatment of patients with insulin-requiring Type II diabetes.  Diabetes Care. 1995;  18 928-932
  • 9 DECODE Study Group . Glucose tolerance and cardiovascular mortality. Comparison of fasting and 2-hour diagnostic criteria.  Arch Intern Med. 2001;  161 397-404
  • 10 Duckworth W C. Hyperglycemia and cardiovascular disease.  Curr Atheroscler Rep. 2001;  3 383-391
  • 11 European Diabetes Policy Group . A desktop guide to Type 2 diabetes mellitus.  Diabetic Medicine. 1999;  16 716-730
  • 12 Frank M, Köglmeier J, Sneige N, Alawi H. Effect of acarbose on the need for between-meal snacking in patients with Type 1 diabetes: a placebo-controlled, double-blind, cross-over study.  Diabetes Nutr Metab. 1998;  11 169-174
  • 13 Haffner S M. The importance of hyperglycemia in the nonfasting state to the development of cardiovascular disease.  Endocrine Reviews. 1998;  19 583-592
  • 14 Hanefeld M, Fischer S, Julius U, Schulze J, Schwanebeck U, Schmechel H, Ziegelasch H J, Lindner J. The DIS Group . Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up.  Diabetologia. 1996;  39 1577-1583
  • 15 Hanefeld M. Post-prandial hyperglycaemia and vascular disease.  Int J Clin Pract. 2000;  (Suppl 112) 13-18
  • 16 Herman M E, Moore R S. The importance of postprandial glucose to treatments and outcomes in patients with Type 2 diabetes.  Manag Care Interface. 2001;  14 63-69
  • 17 Holman R R, Turner R C. Practical guide to basal and prandial insulin therapy.  Diabetic Medicine. 1985;  2 45-53
  • 18 Holman R R, Turner R C, Cull C A. A randomised double blind trial of acarbose in type 2 diabetes shows improved glycaemic control over 3 years (U. K. Prospective Diabetes Study 44).  Diabetes Care. 1999;  22 960-964
  • 19 Howey D C, Bowsher R R, Brunelle R L, Woodworth J R. [Lys(B28), Pro(B29)]-human insulin. A rapidly absorbed analogue of human insulin.  Diabetes. 1994;  43 396-402
  • 20 Kawamori R. Asymptomatic hyperglycaemia and early atheriosclerotic changes.  Diabetes Res Clin Pract. 1998;  40 (Suppl) S35-S42
  • 21 Kelley D E, Bidot P, Freedman Z, Haag B, Podlecki D, Rendell M, Schimel D, Weiss S, Taylor T, Krol A, Magner J. Efficacy and safety of acarbose in insulin-treated patients with Type 2 diabetes.  Diabetes Care. 1998;  21 2056-2061
  • 22 Lebovitz H E. α-Glucosidase inhibitors as agents in the treatment of diabetes.  Diabetes Review. 1998;  6 132-145
  • 23 Mertes G. Safety and efficacy of acarbose in the treatment of Type 2 diabetes: data from a 5-year surveillance study.  Diabetes Res Clin Pract. 2001;  52 193-204
  • 24 Mooradian A D, Thurman J E. Drug therapy of postprandial hyperglycaemia.  Drugs. 1999;  57 19-29
  • 25 Ross S A, Zinman B, Campos R V, Strack T. Canadian Lispro Study Group . A comparative study of insulin lispro and human regular insulin in patients with type 2 diabetes mellitus and secondary failure of oral hypoglycemic agents.  Clin Invest Med. 2001;  24 292-298
  • 26 Temelkova-Kurktschiev T S, Koehler C, Henkel E, Leonhardt W, Fuecker K, Hanefeld M. Postchallenge plasma glucose and glycemic spikes are more strongly associated with atherosclerosis than fasting glucose or HbA1c level.  Diabetes Care. 2000;  23 1830-1834
  • 27 Torlone E, Fanelli C, Rambotti A M, Kassi G, Modarelli F, Di Vincenzo A, Epifano L, Ciofetta M, Pampanelli S, Brunetti P, Bolli G B. Pharmacokinetics, pharmacodynamics and glucose counterregulation following subcutaneous injection of the monomeric insulin analogue [Lsy(B28), Pro(B29)] in IDDM.  Diabetologia. 1994;  37 713-720
  • 28 UK Prospective Diabetes Study Group . Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with Type 2 diabetes (UKPDS 33).  Lancet. 1998;  352 837-853

PD Dr. Norbert Hermanns

FIDAM

Postfach 1144

97961 Bad Mergentheim

Germany

Phone: + 49(0)7931594553

Fax: + 49 (0) 79 31 59 48 95 53

Email: hermanns@diabetes-zentrum.de

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