A 26-week Open Label, Randomised, 2-armed, Parallel Group, Multi-centre Trial Investigating Efficacy and Safety of Insulin Detemir Versus Insulin Neutral Protamine Hagedorn in Combination With the Maximum Tolerated Dose of Metformin and Diet/Exercise on Glycaemic Control in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on the Maximum Tolerated Dose of Metformin ± Other Oral Antidiabetic Drug(s) ± Basal Insulin

TerminadoFase 3ClinicalTrials.gov

ID: NCT02131272Tipo: INTERVENTIONALInicio: 11 de jun de 2014Fin estimado: 14 de jun de 2016

Traducción no disponible, mostrando original

Resumen

This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and diet/exercise on glycaemic control in children and adolescents with type 2 diabetes insufficiently controlled on the maximum tolerated dose of metformin with or without other oral antidiabetic drug(s) with or without basal insulin.

Elegibilidad

Edad mínima: 10 YearsEdad máxima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Fasting C-peptide at screening below 0.6 ng/mL
Maturity onset diabetes of the young (MODY)
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

Intervenciones

drug

Insulin detemir

Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OAD's i.e. metformin treatment should continue unchanged during the treatment period.

drug

Insulin NPH

Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OADs i.e. metformin treatment should continue unchanged during the treatment period.

behavioral

Diet/exercise

Intervention will be performed through family based changes in eating and activity behaviours.

Ubicaciones

Novo Nordisk Investigational Site

CABA, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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