Safety of Insulin Detemir in Children With Type 1 Diabetes
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
7 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Type 1 diabetes for at least one year
Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin
HbA1C below 11.0%
Willing to comply with Investigator's instructions
Able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia
Impaired renal function
Impaired hepatic function
Known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the Investigator or Sub-Investigator)
Proliferative retinopathy or maculopathy requiring acute treatment
Uncontrolled treated/untreated hypertension
Current treatment with total daily insulin dose of more than 2.00 IU/kg
Current treatment or expected at the screening to start treatment with systemic corticosteroids