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
922
mi
from 91732
Amarillo, TX
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Atlanta, Georgia 30318
1919
mi
from 91732
Atlanta, GA
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Buffalo, New York 14222
2181
mi
from 91732
Buffalo, NY
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?
mi
from 91732
Caba,
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Cleveland, Ohio 44106
2032
mi
from 91732
Cleveland, OH
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Columbia, South Carolina 29203
2105
mi
from 91732
Columbia, SC
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Edinburg, Texas 78539
1298
mi
from 91732
Edinburg, TX
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Hershey, Pennsylvania 17033
2295
mi
from 91732
Hershey, PA
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Jacksonville, Florida 32207
2131
mi
from 91732
Jacksonville, FL
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Las Vegas, Nevada 89128
213
mi
from 91732
Las Vegas, NV
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Los Angeles, California 90027
16
mi
from 91732
Los Angeles, CA
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Memphis, Tennessee 38119
1598
mi
from 91732
Memphis, TN
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Milwaukee, Wisconsin 53209
1729
mi
from 91732
Milwaukee, WI
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Norfolk, Virginia 23510
2337
mi
from 91732
Norfolk, VA
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Pembroke Pines, Florida 33026
2314
mi
from 91732
Pembroke Pines, FL
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Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
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Pittsburgh, Pennsylvania 15224
2119
mi
from 91732
Pittsburgh, PA
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Providence, Rhode Island 02908
2562
mi
from 91732
Providence, RI
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Silver Spring, Maryland 20910
2281
mi
from 91732
Silver Spring, MD
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Tallahassee, Florida 32308
1980
mi
from 91732
Tallahassee, FL
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1932
mi
from 91732
Toledo, OH
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Tucson, Arizona 85704
423
mi
from 91732
Tucson, AZ
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Washington, Maryland 20011
?
mi
from 91732
Washington, MD
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