Clinical Trial Result Information

Protocol number
RD000000275

Title of Study
Comparison between CSII with multiple basal Lispro infusion rates and MDI with Lispro and Glargine.

Sponsor
Disetronic Medical Systems AG

Company division
Diagnostic

Product name
Insulin pumps

Therapeutic area
Diabetes Mellitus, Type 1

Clinical study summary
This was a randomised, open label crossover trial to compare Continuous Subcutaneous Insulin Infusion (CSII) vs Multiple Daily Injection (MDI) with glargine as basal insulin in the treatment of adult patients with insulin-dependent diabetes mellitus type 1, with regard to the quality of metabolic control.

Study center(s)
4 centers in Italy

Phase of development
NA

Objectives
To compare the quality of metabolic control in type 1 diabetes obtained by continuous subcutaneous infusion of insulin lispro with that obtained by multiple injections of daily insulin lispro and glargine. To compare the variability of blood glucose characterised by the standard deviation of the mean blood glucose during the last month of the respective treatment period.

Methodology
Eligible patients already on CSII for at least 6 months were randomly assigned to CSII with lispro, or MDI with lispro and glargine. After 4 months they were switched to the alternative treatment. During the last month of each treatment blood glucose variability was analysed using glucose standard deviation, mean amplitude of glycemic excursions (MAGE), lability index and average daily risk range (ADRR).

Number of patients (planned/analyzed)
50 planned. 42 randomised

Diagnosis and main criteria for inclusion
Type 1 diabetic patients, aged 18-60 years of age. Eligible patients should have been diabetic for >2 years, and should have been treated with CSII for >=6 months prior to the study.

Test product, dose and mode of administration or test procedure
CSII with lispro

Duration of treatment
4 months on each treatment

Reference therapy, dose and mode of administration or reference procedure
MDI with injection pen/syringe with lispro and glargine

Criteria for evaluation (efficacy, safety)
Primary: Variability of blood glucose characterized by the standard deviation of the mean blood glucose. Secondary: Quality of metabolic control characterized by the mean blood glucose during the last 4 weeks of the respective treatment period; HbA1c; weekly blood glucose; frequency of severe hypoglycemia; daily insulin requirement; treatment satisfaction measured by DTSQ.

Statistical methods
Mean, median, SD, CV and range; t-test; Wilcoxon test.

Summary (efficacy, safety, other results)
During CSII, glucose variability was 5-12% lower than during MDI with glargine. The difference was significant only before breakfast using glucose standard deviation (p=0.011), significant overall using MAGE (p=0.016) and lability index (p=0.005) and not significant using ADRR. Although HbA1c was similar during both treatments, during CSII blood glucose levels were significantly lower, hyperglycemic episodes were fewer, daily insulin dose was less, free fatty acids were lower and treatment satisfaction was greater than during MDI with glargine. The frequency of hypoglycemic episodes was similar during both treatments.
The number of adverse events, and subjects reporting those events, was similar between treatments. No serious adverse events, diabetic ketoacidosis or hospitalizations or use of an ambulance due to hypoglycemic or ketotic/ketoacidotic events were observed.
The mean total score of the diabetes treatment satisfaction questionnaire was higher in the period of treatment with CSII (32.3) than in the period of MDI (23.2) indicating a higher patient satisfaction when treated with CSII.

Conclusions
During CSII, glucose variability was lower, glycemic control better, and treatment satisfaction higher than during MDI with glargine.

Publications (references, if available)
Bruttomesso D, Crazzolara D, Maran A et al. In Type 1 diabetic patients with good glycemic control, blood glucose variability is lower during continuous subcutaneous insulin infusion than during multiple daily injections with insulin glargine. Diabet. Med. Mar 2008; 25(3):326-32.

Date of report
11/3/2008

Click here for the protocol registry listing of this trial.