An extension trial to NN1250-3582 comparing safety and efficacy of NN1250 and insulin glargine, both with insulin aspart as meal-time insulin ± OADs in type 2 diabetes - BEGIN™: BB

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015816-17-IE

Enrollment

566

Registered

2010-02-25

Start date

2010-07-20

Completion date

Unknown

Last updated

2012-07-31

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

Conditions

Type 2 diabetes MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained before any extension trial-related activities. (Extension trial related activities are defined as any procedure that would not have been performed during normal management of the subject or as part of trial NN1250-3582). 2. The subject must have completed the 52-week treatment period (Visit 41 in trial NN1250-3582). 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 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 (for Germany: implants, injectables, combined oral contraceptives, hormonal intrauterine device (IUD), sexual abstinence or vasectomised partner). 3. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors. 4. For pioglitazone user: clinically significant peripheral oedema or contraindications/restrictions to pioglitazone use.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this extension trial is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 + insulin aspart ± metformin ± pioglitazone to insulin glargine + insulin aspart ± metformin ± pioglitazone after 78 weeks of treatment (52 weeks of treatment in NN1250-3582 plus 26 weeks of treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events. • Hypoglycaemic episodes. • Clinical evaluation. • Central laboratory assessments. • Body weight. • Insulin dose. ;Secondary Objective: The secondary objective is to compare the efficacy between NN1250 and insulin glargine, both in combination with insulin aspart ± metformin ± pioglitazone, after 78 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.	—

Measure

Time frame

Main Objective: The primary objective of this extension trial is to investigate the long-term safety and tolerability of NN1250 in combination with insulin aspart. This is done by comparing NN1250 + insulin aspart ± metformin ± pioglitazone to insulin glargine + insulin aspart ± metformin ± pioglitazone after 78 weeks of treatment (52 weeks of treatment in NN1250-3582 plus 26 weeks of treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: • Adverse events. • Hypoglycaemic episodes. • Clinical evaluation. • Central laboratory assessments. • Body weight. • Insulin dose. ;Secondary Objective: The secondary objective is to compare the efficacy between NN1250 and insulin glargine, both in combination with insulin aspart ± metformin ± pioglitazone, after 78 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.

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Countries

Bulgaria, Germany, Ireland, Italy, Spain

Outcome results

None listed

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