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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013412-13-GB

Enrollment

335

Registered

2009-10-23

Start date

2009-12-02

Completion date

Unknown

Last updated

2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 u

Eligibility

Sex/Gender

All

Inclusion 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

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:

Design outcomes

Primary

Measure	Time frame
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 ;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;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	—

Measure

Time frame

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 ;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;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

—

Countries

Denmark, France, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026