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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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18 April 2012 |
Main ID: |
EUCTR2009-013412-13-GB |
Date of registration:
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23/10/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An extension trial comparing safety and efficacy of NN5401 plus meal-time insulin aspart for the remaining meals with insulin detemir plus meal-time insulin aspart
in type 1 diabetes
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Scientific title:
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An extension trial comparing safety and efficacy of NN5401 plus meal-time insulin aspart for the remaining meals with insulin detemir plus meal-time insulin aspart
in type 1 diabetes |
Date of first enrolment:
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02/12/2009 |
Target sample size:
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335 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013412-13 |
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
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Phase:
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Countries of recruitment
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Denmark
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France
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Informed consent obtained before any trial-related activities. (Trial-related activities are defined as any procedure that would not have been performed during normal management of the subject) 2. The subject must have completed the six-month treatment period (Visit 28) in trial NN5401-3594
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: 1. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO) inhibitors 2. Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits 3. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Germany: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner; for United Kingdom (GB): Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods) 4. Known or suspected allergy to any of the trial products or related products Key assessments:
Age minimum:
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Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Type 1 diabetes MedDRA version: 12.0
Level: LLT
Classification code 10045228
Term: Type I diabetes mellitus
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Intervention(s)
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Product Name: SIAC Product Code: NN5401 Pharmaceutical Form: Solution for injection CAS Number: 844439-96-9 Current Sponsor code: NNC 0100-0000-0454 Other descriptive name: insulin 454 Concentration unit: nmol/ml nanomole(s)/millilitre Concentration type: equal Concentration number: 420- CAS Number: 116094-23-6 Other descriptive name: insulin aspart Concentration unit: nmol/ml nanomole(s)/millilitre Concentration type: equal Concentration number: 180-
Trade Name: Levemir® Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN DETEMIR CAS Number: 169148-63-4 Other descriptive name: insulin detemir Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100-
Trade Name: NovoRapid® Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Other descriptive name: insulin aspart Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Secondary Objective: The secondary objective is to compare the efficacy between SIAC and insulin detemir after 52 weeks of treatment in terms of the following assessments from which endpoints will be calculated: • HbA1c • Fasting plasma glucose (FPG) • 9-point self measured plasma glucose profile (9-point profile (SMPG)) • Self measured plasma glucose (SMPG) for dose adjustments
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Main Objective: The primary objective is to investigate the long-term safety and tolerability of SIAC. This is done by comparing SIAC to insulin detemir after 52 weeks of treatment (26 weeks of treatment in trial NN5401-3594 plus 26 weeks of treatment in this extension trial) in terms of the following safety assessments from which endpoints will be calculated: • Adverse events • Hypoglycaemic episodes • Clinical evaluations • Central laboratory assessments including lipid profiles and insulin antibodies • Body weight • Insulin dose
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Primary end point(s): • Number of treatment emergent adverse events with an onset on or after the first day of exposure to randomised trial drug and no later than 7 days after last exposure to randomised trial drug • Number of severe and minor treatment emergent hypoglycaemic episodes with an onset on or after the first day of exposure to randomised trial drug and not later than 7 days after last exposure to randomised trial drug • Change from baseline in antibodies after 52 weeks of treatment • Change from baseline in HbA1c after 52 weeks of treatment
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Secondary ID(s)
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NN5401-3645
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Source(s) of Monetary Support
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Results
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Results available:
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