A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
10–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Informed consent from the subject or a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities.Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, above or equal to 10 years and below or equal to 17 years at the time of signing informed consent/assent
Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
Treated with the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance
HbA1c (glycosylated haemoglobin) above or equal to 7.0% and below or equal to 10.5% (above or equal to 53 mmol/mol and below or equal to 91 mmol/mol) at screening
You may not be if
Maturity onset diabetes of the young (MODY)
Fasting C-peptide at screening below 0.6 ng/mL
Impaired liver function defined as alanine aminotransferase (ALT) above or equal to 2.5 times upper normal limit
Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
Clareo Health | A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
