Study title: Morning Lantus® (insulin glargine [rDNA origin] injection) vs. intermediateacting insulin twice daily as basal insulin in a multiple daily injection regimen with Humalog® (insulin lispro injection [rDNA Origin]) in pediatrics with type 1 diabetes mellitus: an activeontrolled, open, randomized, gender-stratified, two arm, parallel-group study.
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Endocrine System Diseases | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: INSULIN GLARGINE | |||||
ATC code: A10AE04 | |||||
Document link: | |||||
Document date: 2011-09-23 | |||||
Study number: HOE901/4030 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
- | - | - | - | Y |