An extension trial to trial NN1250-3583 comparing safety and efficacy of NN1250 with insulin glargine, both with insulin aspart as meal-time insulin, in type 1 diabetes - BEGIN™: T1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015755-24-FR

Enrollment

396

Registered

2010-02-23

Start date

2010-04-08

Completion date

Unknown

Last updated

2021-10-18

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: 12.1 Level: LLT Classification code 10067584 Term: Type 1 diabetes mellitus

Interventions

Product Name: NN1250 Product Code: NN1250 Pharmaceutical Form: Solution for injection Current Sponsor code: 0100-0000-0454 Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained before any extension trial-related activities (Extension trial-related activities are any procedure that would not have been performed during normal management of the subject or as part of the main trial NN1250-3583.) 2. The subject must have completed the 52 weeks treatment period in trial NN1250-3583 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. Previous participation in this extension trial. Participation is defined as participation in any Visit 43 related procedures 2. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) (for Germany: implants, injectables, combined oral contraceptives, hormonal intrauterine device (IUD), sexual abstinence or vasectomised partner)(for UK: 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) 3. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 to insulin glargine, both in combination with insulin aspart, after 104 weeks of treatment (52-weeks treatment in NN1250-3583 plus 52-week treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events (AE) • Hypoglycaemic episodes • Clinical evaluation • Central laboratory assessments • Body weight • Insulin dose The data from trial NN1250-3583 and this extension trial will be combined and analysed as one (2-year) trial using the baseline values from trial NN1250-3583.;Secondary Objective: The secondary objective is to compare the efficacy between NN1250 and insulin glargine, both in combination with insulin aspart, after 104 weeks of treatment, in terms of the listed efficacy assessments from which endpoints will be calculated: • HbA1c (central laboratory) • Fasting plasma glucose (FPG) measured at a central laboratory • 9-point self-measured plasma glucose (SMPG) profile • 4-point self-measured plasma glucose (SMPG) profile;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 insulin antibodies after 104 weeks of treatment	—

Measure

Time frame

Main Objective: The primary objective is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 to insulin glargine, both in combination with insulin aspart, after 104 weeks of treatment (52-weeks treatment in NN1250-3583 plus 52-week treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events (AE) • Hypoglycaemic episodes • Clinical evaluation • Central laboratory assessments • Body weight • Insulin dose The data from trial NN1250-3583 and this extension trial will be combined and analysed as one (2-year) trial using the baseline values from trial NN1250-3583.;Secondary Objective: The secondary objective is to compare the efficacy between NN1250 and insulin glargine, both in combination with insulin aspart, after 104 weeks of treatment, in terms of the listed efficacy assessments from which endpoints will be calculated: • HbA1c (central laboratory) • Fasting plasma glucose (FPG) measured at a central laboratory • 9-point self-measured plasma glucose (SMPG) profile • 4-point self-measured plasma glucose (SMPG) profile;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 insulin antibodies after 104 weeks of treatment

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Countries

France, Germany, United Kingdom

Outcome results

None listed

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