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
NCT ID: NCT02131272
Last Updated: 2018-09-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
42 participants
INTERVENTIONAL
2014-06-11
2016-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin detemir and diet/exercise
Current OADs i.e. metformin or other OADs are continued unchanged
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.
Diet/exercise
Intervention will be performed through family based changes in eating and activity behaviours.
Insulin NPH and diet/exercise
Current OADs i.e. metformin or other OADs are continued unchanged
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.
Diet/exercise
Intervention will be performed through family based changes in eating and activity behaviours.
Interventions
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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.
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.
Diet/exercise
Intervention will be performed through family based changes in eating and activity behaviours.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Tucson, Arizona, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Pembroke Pines, Florida, United States
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Tallahassee, Florida, United States
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Atlanta, Georgia, United States
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Reisterstown, Maryland, United States
Novo Nordisk Investigational Site
Silver Spring, Maryland, United States
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Las Vegas, Nevada, United States
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Buffalo, New York, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Amarillo, Texas, United States
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Edinburg, Texas, United States
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Norfolk, Virginia, United States
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Milwaukee, Wisconsin, United States
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CABA, , Argentina
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Aparecida de Goiânia, Goiás, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Zagreb, , Croatia
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Alexandria, , Egypt
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Cairo, , Egypt
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Cairo, , Egypt
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Ludwigshafen, , Germany
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Neuwied, , Germany
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Goudi/ Athens, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Miskolc, , Hungary
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Hyderabad, Andhra Pradesh, India
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Hyderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Chennai, Tamil Nadu, India
Novo Nordisk Investigational Site
Kolkata, West Bengal, India
Novo Nordisk Investigational Site
Beersheba, , Israel
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Haifa, , Israel
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Ancona, , Italy
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Florence, , Italy
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Beirut, , Lebanon
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Hazmiyeh, , Lebanon
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Lebanon - Beirut, , Lebanon
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Seremban, , Malaysia
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Seri Manjung, , Malaysia
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Puebla City, , Mexico
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Casablanca, , Morocco
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Fes, , Morocco
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Marrakesh, , Morocco
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Rabat, , Morocco
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Wroclaw, , Poland
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Lisbon, , Portugal
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Izhevsk, , Russia
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Stavropol, , Russia
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Tomsk, , Russia
Novo Nordisk Investigational Site
Niš, , Serbia
Novo Nordisk Investigational Site
Lenasia, Gauteng, South Africa
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa
Novo Nordisk Investigational Site
Observatory, Western Cape, South Africa
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Seoul, , South Korea
Novo Nordisk Investigational Site
Esplugues Llobregat(Barcelona), , Spain
Novo Nordisk Investigational Site
Taichung, , Taiwan
Novo Nordisk Investigational Site
Taoyuan District, , Taiwan
Novo Nordisk Investigational Site
Adana, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Ankara, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Kayseri, , Turkey (Türkiye)
Countries
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References
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Wheeler MD, Barrientos-Perez M, Lo FS, Liang B, Lunsford A, Thorisdottir O, Zuckerman-Levin N. A 26-week, randomized trial of insulin detemir versus NPH insulin in children and adolescents with type 2 diabetes (iDEAt2). Eur J Pediatr. 2018 Oct;177(10):1497-1503. doi: 10.1007/s00431-018-3205-z. Epub 2018 Jul 16.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2013-005500-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1151-4056
Identifier Type: OTHER
Identifier Source: secondary_id
2015-1316
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN304-4093
Identifier Type: -
Identifier Source: org_study_id
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