Type 1 Diabetes Mellitus Clinical Trial
Official title:
A 24-week, Randomized, Open-label, Parallel Group Multinational Comparison of Lantus® (Insulin Glargine) Given in the Morning as Once-a-day Basal Insulin Versus Neutral Protamine Hagedorn (NPH) Insulin, in Children With Type 1 Diabetes Mellitus Aged at Least 1 Year to Less Than 6 Years
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
Screening phase: 2 to 4 weeks
Treatment phase: 24 weeks
At randomization, patients were stratified with respect to their baseline HbA1c level (<8.5%
or ≥8.5%) and hypoglycemic event rate (number of CGMS hypoglycemic excursions <0.5 or ≥0.5
events per 24 hours). Following randomization, trial basal insulin was initiated and
up-titrated within the first 12 weeks to reach a stable dose.
Follow-up phase: 2 weeks
All Phases: 28 to 30 weeks
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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