Study title: The Exclusive Use of Neutral Regular Human Insulin (rDNA) in the Treatment of Insulin-Dependent Diabetes Mellitus in Patients Who Have Never Received Insulin
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Endocrine System Diseases [C19] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: INSULIN (HUMAN) | |||||
ATC code: A10AB01 | |||||
Document link: Human insulin - B5K-MC-IBAI redacted CSR.PDF | |||||
Document date: 2011-09-16 | |||||
Study number: B5K-MC-IBAI | |||||
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) |
- | - | - | - | - |