Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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1 February 2016 |
Main ID: |
EUCTR2013-005500-33-HU |
Date of registration:
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25/06/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A 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
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Scientific title:
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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 |
Date of first enrolment:
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24/09/2014 |
Target sample size:
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358 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005500-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Argentina
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Brazil
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Canada
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China
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Croatia
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Egypt
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European Union
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Germany
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Greece
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Hungary
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India
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Israel
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Japan
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Lebanon
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Macedonia, the former Yugoslav Republic of
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Malaysia
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Mexico
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Morocco
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Portugal
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Russian Federation
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Serbia
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South Africa
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Spain
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Taiwan
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Turkey
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Novo Allé
2880
Bagsvaerd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Name:
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Global Clinical Registry (GCR,1452)
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Address:
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Novo Allé
2880
Bagsvaerd
Denmark |
Telephone:
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Email:
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clinicaltrials@novonordisk.com |
Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 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 XML File Identifier: xz03n7mDeeRWhsZnwdHjlWpab9U=Page 15/26
2. Male or female, 10 years = age =17 years at the time of signing informed consent/assent
3. Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening
4. Treated with the maximum tolerated stable dose of metformin for at least 3 months prior to screening or have documented complete metformin intolerance. Note other OADs and basal insulin are allowed; bolus insulin is only allowed as rescue treatment for a maximum of 7 days for the last 3 months prior to screening
5. HbA1c; = 7.0% and = 10.5% (= 53 mmol/mol and = 91 mmol/mol) at screening Are the trial subjects under 18? yes Number of subjects for this age range: 358 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Maturity onset diabetes of the young (MODY)
2. Fasting C-peptide at screening <0.6 ng/mL
3. Impaired liver function defined as alanine aminotransferase (ALT) = 2.5 times upper normal limit
4. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator
5. 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2 MedDRA version: 18.0
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
System Organ Class: 100000004861
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Intervention(s)
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Trade Name: Levemir Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN DETEMIR CAS Number: 169148-63-4 Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100-
Trade Name: Insulatard Pharmaceutical Form: Suspension for injection in pre-filled pen INN or Proposed INN: INSULIN HUMAN CAS Number: 11061-68-0 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Main Objective: To compare the efficacy of insulin detemir in combination with metformin and diet/exercise versus insulin Neutral Protamine Hagedorn (NPH) in combination with the max. tolerated dose (MTD) of metformin and diet/exercise in controlling glycaemia, after 26 weeks of treatment, in children and adolescents (aged 10–17 years) with type 2 diabetes (T2D), who are insufficiently treated with the MTD of metformin ± other OAD(s) ± basal insulin.
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Secondary Objective: In children and adolescents (aged 10–17 years) with T2D insufficiently treated with the MTD of metformin ± other OAD(s) ± basal insulin: 1. To compare the efficacy of insulin detemir in combination with the MTD of metformin and diet/exercise vs. insulin NPH in combination with the MTD of metformin and diet/exercise on body weight, after 26 weeks' treatment 2. To compare the proportion of subjects achieving glycaemic control without experiencing severe hypoglycaemia, after 26 weeks' treatment, for insulin detemir in combination with the MTD of metformin and diet/exercise vs. insulin NPH in combination with the MTD of metformin and diet/exercise 3. To assess and compare the safety and tolerability of insulin detemir in combination with the MTD of metformin and diet/exercise vs. insulin NPH in combination with the MTD of metformin and diet/exercise, during 26 weeks' treatment
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Primary end point(s): Change in HbA1c
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Timepoint(s) of evaluation of this end point: From baseline to Week 26
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Secondary Outcome(s)
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Secondary end point(s): 1. Change in body weight standard deviation score (SDS)
2. Proportion of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
3. Proportion of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment
4. Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes
5. Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes
6. Incidence of adverse events (AEs)
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Timepoint(s) of evaluation of this end point: 1. From baseline to Week 26
2. - 3. At Week 26
4. - 6. During 26 weeks of treatment
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Secondary ID(s)
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NN304-4093
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Source(s) of Monetary Support
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Novo Nordisk A/S
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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