Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial.

Abstract

BACKGROUND:

In a previous pilot study comparing insulin glulisine (GLU) with insulin aspart (ASP) administered by continuous subcutaneous insulin infusion (CSII), GLU-treated patients did show a trend toward fewer catheter occlusions compared with ASP-treated patients. Here we performed a randomized open-label, three-way crossover, controlled multicenter study comparing GLU with ASP and insulin lispro (LIS).

METHODS:

Subjects with type 1 diabetes were allocated to one of three treatment orders-GLU-ASP-LIS, ASP-LIS-GLU, or LIS-GLU-ASP-with each insulin used for 13 weeks. The study was designed to demonstrate the superiority of GLU over ASP and LIS on unexplained hyperglycemia and/or perceived infusion set occlusion. A prespecified P value of 0.025 was considered significant to correct for multiple testing.

RESULTS:

Percentages of subjects with at least one unexplained hyperglycemia and/or infusion set occlusion were not significantly different between GLU and ASP (68.4% [62.7-74.1%] vs. 62.1% [56.2-68.1%], P = 0.04) and GLU and LIS (68.4% [62.7-74.1%] vs. 61.3% [55.4-67.3%], P = 0.03). No differences were seen in hemoglobin A1c at end point, most points of the seven-point glucose curves, severe hypoglycemia, and symptomatic ketoacidosis. The overall rate of hypoglycemia with a plasma glucose level below 70 mg/dL per patient-year was significantly different between GLU and ASP (73.84 vs. 65.01, P = 0.008) and GLU and LIS (73.84 vs. 62.69, P < 0.001). Insulin doses remained unchanged during the trial.

CONCLUSIONS:

GLU was not superior to ASP and LIS with no significant difference seen among GLU, ASP, and LIS in CSII use with respect to unexplained hyperglycemia and/or perceived catheter set occlusion. GLU was associated with a higher frequency of symptomatic hypoglycemia, possibly because of slight overdosing, as previous trials suggested lower insulin requirements when GLU is initiated in type 1 diabetes.

• Authors: Arianne C van Bon, Bruce W Bode, Caroline Sert-Langeron, J Hans DeVries, Guillaume Charpentier
• Journal: Diabetes technology & therapeutics (Diabetes Technol Ther) Vol. 13 Issue 6 Pg. 607-14 (Jun 2011) ISSN: 1557-8593 [Electronic] United States
• PMID: 21457066 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Glycated Hemoglobin A
• Hypoglycemic Agents
• Insulin
• Insulin Lispro
• hemoglobin A1c protein, human
• insulin glulisine
• Insulin Aspart

Topics

• Adult
• Cross-Over Studies
• Diabetes Mellitus, Type 1 (blood, drug therapy)
• Diabetic Ketoacidosis (prevention & control)
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemia (prevention & control)
• Hypoglycemic Agents (administration & dosage, therapeutic use)
• Insulin (administration & dosage, analogs & derivatives, therapeutic use)
• Insulin Aspart
• Insulin Infusion Systems
• Insulin Lispro
• Male
• Middle Aged
• Statistics as Topic
• Time Factors