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

• Register: EUCTR
• Last refreshed on: 8 October 2021
• Main ID: EUCTR2009-013412-13-FR
• Date of registration: 05/11/2009
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: 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
• Scientific title: 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: 18/01/2010
• Target sample size: 335
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013412-13
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Denmark, France, United Kingdom

Key inclusion & exclusion criteria

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:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 1 diabetes
MedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus

Intervention(s)

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-

Primary Outcome(s)

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

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

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

Secondary ID(s)

NN5401-3645

2009-013412-13-GB

Ethics review

Status: Approved
Approval date: 18/01/2010
Contact:

Results

• Results available: Yes
• Date Posted: 30/01/2016
• Date Completed: 02/12/2010
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-013412-13/results