A Randomized Clinical Trial of Insulin Glargine and Aspart, Compared to NPH and Regular Insulin in Children with Type 1 Diabetes Mellitus

Parastoo Rostami Md, Aria Setoodeh Md, Ali Rabbani Md, Maryam Nakhaei-Moghadam Md, Farnaz Najmi-Varzaneh Md, Nima Rezaei Md PhD, Parastoo Rostami Md, Aria Setoodeh Md, Ali Rabbani Md, Maryam Nakhaei-Moghadam Md, Farnaz Najmi-Varzaneh Md, Nima Rezaei Md PhD

Abstract

Objective: Appropriate treatment of patients with Type 1 diabetes mellitus (T1DM) is necessary to avoid further complications. This study was performed to compare the efficacy of insulin Glargine and Aspart with NPH insulin and regular insulin regimen in a group of children with T1DM.

Methods: Forty patients with T1DM were enrolled in this study. During run-in, all subjects were treated with conventional therapy consisting of twice-daily NPH and thrice-daily regular. Following randomization, 20 subjects received Glargine and Aspart and 20 subjects received NPH and Regular insulin.

Findings: Mean HbA1c was 8.8% and 8.6% at first and 8.4% and 8.2% at the end of study for subjects randomized initially to Glargine and Aspart and for those randomized to NPH and Regular, respectively (P>0.05). Mean fasting blood glucose (FBS) of the subjects randomized initially to Glargine and Aspart was 217±101 mg/dL, with no significant difference to 196±75 mg/dL for those randomized to NPH and Regular (P=0.48). This was also true at the end of the study. The difference in total cholesterol and triglyceride between the two groups in the beginning of study and at the end did not show any significance.

Conclusion: The current study showed no significant difference in glycemic control [Glycated hemoglobin (HbA1c) and FBS] and lipid profile (total cholesterol and triglyceride) between two regimes.

Keywords: Conventional Therapy; Insulin Aspart; Insulin Glargine; Type 1 Diabetes Mellitus.

References

    1. Zhao Y, Jiang Z, Zhao T, et al.Reversal of type 1 diabetes via islet beta cell regeneration following immune modulation by cord blood-derived multipotent stem cells. BMC Med 2012;10:3.
    1. Long AE, Gillespie KM, Rokni S, et al.Rising incidence of type 1 diabetes is associated with altered immunophenotype at diagnosis. Diabetes 2012;61(3):683–6.
    1. Nordwall M, Arnqvist HJ, Bojestig M, et al.Good glycemic control remains crucial in prevention of late diabetic complications -- the Linkoping Diabetes Complications Study. Pediatr Diabetes 2009; 10(3):168–76.
    1. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329(14):977–86.
    1. Dimitriadis GD, Gerich JE.Importance of timing of preprandial subcutaneous insulin administration in the management of diabetes mellitus. Diabetes Care 1983;6(4):374–7.
    1. Binder C, Lauritzen T, Faber O, et al.Insulin pharmacokinetics. Diabetes Care 1984;7(2):188–99.
    1. Vandewalle CL, Coeckelberghs MI, De Leeuw IH, et al.Epidemiology, clinical aspects, and biology of IDDM patients under age 40 years. Comparison of data from Antwerp with complete ascertainment with data from Belgium with 40% ascertainment. The Belgian Diabetes Registry. Diabetes Care 1997; 20(10):1556–61.
    1. Winkley K, Ismail K, Landau S, et al.Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. BMJ 2006;333(7558):65.
    1. Bolli GB, Di Marchi RD, Park GD, et al.Insulin analogues and their potential in the management of diabetes mellitus. Diabetologia 1999;42(10):1151–67.
    1. Pesic M, Zivic S, Radenkovic S, et al.Comparison between basal insulin glargine and NPH insulin in patients with diabetes type 1 on conventional intensive insulin therapy. Vojnosanit Pregl 2007; 64(4):247–52.
    1. Hosoi Y, Ohtani K, Shimizu H, et al.Attainment of glycaemic goals by step-up therapy with biphasic insulin aspart-70/30 in Japanese type 2 diabetic patients. Endocr J 2011;58(2):131–5.
    1. Witthaus E, Stewart J, Bradley C. Treatment satisfaction and psychological well-being with insulin glargine compared with NPH in patients with Type 1 diabetes. Diabet Med 2001;18(8):619–25.
    1. Ratner RE, Hirsch IB, Neifing JL, et al.Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes Care 2000;23(5):639–43.
    1. Pan CY, Sinnassamy P, Chung KD, et al.Insulin glargine versus NPH insulin therapy in Asian Type 2 diabetes patients. Diabetes Res Clin Pract 2007; 76(1):111–8.
    1. Hassan K, Rodriguez LM, Johnson SE, et al.A randomized, controlled trial comparing twice-a-day insulin glargine mixed with rapid-acting insulin analogs versus standard neutral protamine Hagedorn (NPH) therapy in newly diagnosed type 1 diabetes. Pediatrics 2008;121(3):e466–72.
    1. McMahon MM, Nystrom E, Braunschweig C, et al.A.S.P.E.N. Clinical Guidelines: Nutrition support of adult patients with hyperglycemia. JPEN J Parenter Enteral Nutr 2013;37(1):23–36.
    1. Home PD, Rosskamp R, Forjanic-Klapproth J, et al.A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. Diabetes Metab Res Rev 2005;21(6):545–53.
    1. Chatterjee S, Jarvis-Kay J, Rengarajan T, et al.Glargine versus NPH insulin: efficacy in comparison with insulin aspart in a basal bolus regimen in type 1 diabetes -- the glargine and aspart study (GLASS) a randomised cross-over study. Diabetes Res Clin Pract 2007;77(2):215–22.
    1. Philippe J. How to minimize weight gain associated with insulin treatment. Rev Med Suisse 2010;6(252):1199–1200, 1202–4.
    1. Garg SK, Paul JM, Karsten JI, et al.Reduced severe hypoglycemia with insulin glargine in intensively treated adults with type 1 diabetes. Diabetes Technol Ther 2004;6(5):589–95.
    1. Hansen B, Lilleore SK, Ter-Borch G. Needle with a novel attachment versus conventional screw-thread needles: a preference and usability test among adults with diabetes and impaired manual dexterity. Diabetes Technol Ther 2011;13(5):579–85.
    1. Hornquist JO, Wikby A, Andersson PO, et al.Insulin-pen treatment, quality of life and metabolic control: retrospective intra-group evaluations. Diabetes Res Clin Pract 1990;10(3):221–30.
    1. Tallroth G, Karlson B, Nilsson A, et al.The influence of different insulin regimens on quality of life and metabolic control in insulin-dependent diabetics. Diabetes Res Clin Pract 1989;6(1):37–43.
    1. Piscopo MA, Chiesa G, Bonfanti R, et al.Quality of life and new devices in the management of type 1 diabetes in children and adolescents. Acta Biomed 2003;74(Suppl 1):21–5.
    1. Howe CJ, Jawad AF, Tuttle AK, et al.Education and telephone case management for children with type 1 diabetes: a randomized controlled trial. J Pediatr Nurs 2005;20(2):83–95.

Source: PubMed

3
Subskrybuj