6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome
of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous
glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG),
low FSBG readings performed at other times) between children treated with Lantus (insulin
glargine) and Neutral Protamine Hagedorn (NPH) insulin.
Secondary objectives were to compare insulin glargine and NPH in terms of:
- rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal
symptomatic, and severe nocturnal symptomatic hypoglycemia
- HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment
- percentage of patients reaching HbA1c less than 7.5% (target value) at end of treatment
- average blood glucose over whole trial and at end of trial, as estimated by continuous
glucose monitoring (CGM), and blood glucose variability