Glycemic control after 6 days of insulin pump reservoir use in type 1 diabetes: results of double-blind and open-label cross-over trials of insulin lispro and insulin aspart.

Abstract

BACKGROUND:

The objective of the current study was to assess mean self-monitored blood glucose (SMBG), on day 6 of 6 days of continuous reservoir wear (6D), with insulin lispro (Lis) or insulin aspart (Asp).

METHODS:

Two 24-week, randomized trials were conducted in subjects with type 1 diabetes treated by continuous subcutaneous insulin infusion (CSII) for ≥6 months, with a mean total daily insulin dose capable of supporting 6 days of in-reservoir use. Study 1 had an open-label, six-sequence, three-treatment, three-period, cross-over design. Study 2 had a double-blind, two-sequence, two-treatment, two-period, cross-over design. The primary efficacy measure was the mean of Day 6, seven-point SMBG profiles for insulin lispro 6D (Lis6D) and insulin aspart 6D (Asp6D) treatment periods. Safety measures were also assessed.

RESULTS:

Lis did not achieve noninferiority (SMBG; margin = 0.6 mmol/L [10.8 mg/dL]) to Asp on Day 6 of reservoir wear in either Study (least-squares mean difference: Study 1 = 0.48 mmol/L [8.64 mg/dL]; 95% confidence interval [CI] [0.20, 0.76], Study 2 = 0.36 mmol/L [6.49 mg/dL]; 95% CI [0.06, 0.66]). Noninferiority was demonstrated for overall daily mean of SMBG values over days 1 to 6 of reservoir use during each treatment period. In the Lis treatment period, subjects reported a lower documented and total hypoglycemia rate per 30 days and a higher rate of non-explained hyperglycemia than in the Asp treatment period.

CONCLUSION:

While the mean blood glucose on Day 6 of Lis6D did not meet non-inferiority, the overall daily mean blood glucose was not different, with a decreased rate of hypoglycemia with Lis.

• Authors: William V Tamborlane, Eric Renard, R Paul Wadwa, Thomas Blevins, Scott J Jacober, Rong Liu, Deborah N D'Souza, Tina M Rees
• Journal: Journal of diabetes (J Diabetes) Vol. 7 Issue 2 Pg. 270-8 (Mar 2015) ISSN: 1753-0407 [Electronic] Australia
• PMID: 24734891 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Chemical References

• Blood Glucose
• Hypoglycemic Agents
• Insulin Lispro
• Insulin Aspart

Topics

• Adult
• Blood Glucose (analysis)
• Blood Glucose Self-Monitoring
• China
• Cross-Over Studies
• Diabetes Mellitus, Type 1 (drug therapy)
• Diabetes Mellitus, Type 2 (drug therapy)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Hyperglycemia (prevention & control)
• Hypoglycemia (prevention & control)
• Hypoglycemic Agents (therapeutic use)
• Insulin Aspart (therapeutic use)
• Insulin Infusion Systems
• Insulin Lispro (therapeutic use)
• Male
• Postprandial Period
• Prognosis
• Risk Factors