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

• Register: EUCTR
• Last refreshed on: 31 July 2012
• Main ID: EUCTR2009-015816-17-IE
• Date of registration: 25/02/2010
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 20/07/2010
• Target sample size: 566
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015816-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no 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

Countries of recruitment

Bulgaria, Germany, Ireland, Italy, Spain

Key inclusion & exclusion 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:
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.


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

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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
Concentration number: 100-

Trade Name: Lantus
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN GLARGINE
CAS Number: 160337-95-1
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

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.

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.

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.

Secondary ID(s)

NN1250-3667