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



Status:Terminated
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 18
Updated:9/12/2018
Start Date:June 11, 2014
End Date:June 14, 2016

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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

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.


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
We found this trial at
23
sites
Amarillo, Texas 79106
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Amarillo, TX
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Atlanta, Georgia 30318
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Atlanta, GA
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Buffalo, New York 14222
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Buffalo, NY
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Caba,
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Cleveland, Ohio 44106
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Cleveland, OH
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Columbia, South Carolina 29203
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Columbia, SC
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Edinburg, Texas 78539
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Edinburg, TX
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Hershey, Pennsylvania 17033
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from
Hershey, PA
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Jacksonville, Florida 32207
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Jacksonville, FL
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Las Vegas, Nevada 89128
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Las Vegas, NV
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Los Angeles, California 90027
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Los Angeles, CA
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Memphis, Tennessee 38119
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Memphis, TN
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Milwaukee, Wisconsin 53209
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Milwaukee, WI
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Norfolk, Virginia 23510
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Norfolk, VA
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Pembroke Pines, Florida 33026
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Pembroke Pines, FL
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Providence, Rhode Island 02908
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Providence, RI
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Silver Spring, Maryland 20910
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Silver Spring, MD
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Tallahassee, Florida 32308
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Tallahassee, FL
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Toledo, OH
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Tucson, Arizona 85704
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Tucson, AZ
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Washington, Maryland 20011
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from
Washington, MD
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