Insulin Glargine Maintains Equivalent Glycemic Control and Better Lipometabolic Control than NPH Insulin in Type 1 Diabetes Patients Who Missed a Meal

Abstract

Our goal was to investigate blood glucose and lipometabolism control in type 1 diabetes patients who missed breakfast and the accompanying insulin injection of NPH insulin (NPH) or insulin glargine (glargine) as part of a basal–bolus regimen. This was a multi-center, open-label, controlled study in adults (≥18 years) with HbA_1c≤11.5% on insulin therapy with NPH as basal insulin. Patients were randomized to receive prandial insulin plus either bedtime glargine (n=28) or NPH (n=32). Insulin was titrated to target fasting blood glucose levels 80–130 mg/dl at 06:00–07:00. Patients had no intake of insulin or food between 22:00 and 12:00 the next day. The change in blood glucose levels (07:00–11:00) was similar (27.5 mg/dl vs. 35.4 mg/dl), but the mean blood glucose level was higher with glargine vs. NPH at 22:00 (158.2 mg/dl vs. 130.2 mg/dl). During the period without insulin or food intake, blood glucose decreased with glargine (–25.8 mg/dl) and increased with NPH (+9.1 mg/dl; p=0.0284). Nonesterified fatty acid (07:00 and 09:00–12:00) and β-hydroxybutyrate (07:00 and 10:00–12:00) levels were lower with glargine vs. NPH (both p<0.05). For patients who miss a morning meal, glargine is associated with maintained glycemic and lipometabolic control compared with NPH insulin.

Key words

basal insulin - blood glucose - flexibility - insulin analogue

References

• 1 Yki-Järvinen H, Dressler A, Ziemen M. Less nocturnal hypoglycemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group.  Diabetes Care. 2000;  23 1130-1136
• 2 Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo.  Diabetes Care. 2000;  23 644-649
• 3 Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Vincenzo A Di, Cordoni C, Costa E, Brunetti P, Bolli GB. 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 Owens D, Coates P, Luzio S, Tinbergen J, Kurzhals R. Pharmacokinetics of [125]I-labelled insulin glargine (HOE 901) in healthy men.  Diabetes Care. 2000;  23 813-819
• 5 Massi Benedetti M, Humburg E, Dressler A, Ziemen M. A one-year, randomised, multicentre trial comparing insulin glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes.  Horm Metab Res. 2003;  35 189-196
• 6 Riddle M, Rosenstock J, Gerich J. Insulin Glargine 4002 Study Investigators: The Treat-to-Target Trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients.  Diabetes Care. 2003;  26 3080-3086
• 7 Scholtz HE, Pretorius SG, Wessels DH, Becker RH. Pharmacokinetic and glucodynamic variability: assessment of insulin glargine, NPH insulin and insulin ultralente in healthy volunteers using a euglycaemic clamp technique.  Diabetologia. 2005;  48 1988-1995
• 8 Rossetti P, Pampanelli S, Fanelli C, Porcellati F, Costa E, Torlone E, Scionti L, Bolli GB. Intensive replacement of basal insulin in patients with type 1 diabetes given rapid-acting insulin analog at mealtime: a 3-month comparison between administration of NPH insulin four times daily and glargine insulin at dinner or bedtime.  Diabetes Care. 2003;  26 1490-1496
• 9 Hamann A, Matthaei S, Rosak C, Silvestre L. HOE901/4007 Study Group . A randomized clinical trial comparing breakfast, dinner, or bedtime administration of insulin glargine in patients with type 1 diabetes.  Diabetes Care. 2003;  26 1738-1744
• 10 Garg SK, Gottlieb PA, Hisatomi ME, D’Souza A, Walker AJ, Izuora KE, Chase HP. Improved glycemic control without an increase in severe hypoglycemic episodes in intensively treated patients with type 1 diabetes receiving morning, evening, or split dose insulin glargine.  Diabetes Res Clin Pract. 2004;  66 49-56
• 11 Bradley C, Speight J. Patient perceptions of diabetes and diabetes therapy: assessing quality of life.  Diabetes Metab Res Rev. 2002;  18 S64-S69

1 Clinical Trials.gov identifier: NCT00313937

Correspondence