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.
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria in a period of 3 months before the day of screening
Caba C1425DUC, Argentina; Recruiting
Zagreb 10000, Croatia; Recruiting
Cairo, Egypt; Recruiting
Neuwied 56564, Germany; Recruiting
Goudi/ Athens GR-11527, Greece; Recruiting
Budapest 1083, Hungary; Recruiting
Haifa 31096, Israel; Recruiting
Firenze 50139, Italy; Recruiting
Seoul 143-729, Korea, Republic of; Recruiting
Beirut, Lebanon; Recruiting
Kota Bharu, Kelantan 16150, Malaysia; Recruiting
Puebla 72190, Mexico; Recruiting
Casablanca 20000, Morocco; Recruiting
Wroclaw 50-311, Poland; Recruiting
Lisboa 1250-230, Portugal; Recruiting
Tomsk 634034, Russian Federation; Recruiting
Nis 18 000, Serbia; Recruiting
Esplugues Llobregat 08950, Spain; Recruiting
Taichung 404, Taiwan; Recruiting
Istanbul 34093, Turkey; Recruiting
Novo Nordisk Clinical Trial Call Center, Tucson, Arizona 85724, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90027, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Washington, District of Columbia 20020, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Jacksonville, Florida 32207-8426, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Pembroke Pines, Florida 33026, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Tallahassee, Florida 32308, United States; Recruiting
Lenasia, Gauteng 1827, South Africa; Recruiting
Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30322, United States; Recruiting
Ahmedabad, Gujarat 380007, India; Recruiting
Novo Nordisk Clinical Trial Call Center, Silver Spring, Maryland 20910, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89128, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Buffalo, New York 14222, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Sleepy Hollow, New York 10591, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44195-0001, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Hershey, Pennsylvania 17033, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Providence, Rhode Island 02903, United States; Recruiting
São Paulo, Sao Paulo 01228-000, Brazil; Recruiting
Novo Nordisk Clinical Trial Call Center, Columbia, South Carolina 29203, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Memphis, Tennessee 38119, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Amarillo, Texas 79106, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Edinburg, Texas 78539, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Norfolk, Virginia 23507, United States; Recruiting
Novo Nordisk Clinical Trial Call Center, Milwaukee, Wisconsin 53226, United States; Recruiting