An extension trial to NN1250-3579 comparing safety and efficacy of NN1250 plus OAD(s) with insulin glargine plus OAD(s) in type 2 diabetes - BEGIN™: ONCE LONG

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2009-015754-38-FI
• Date of registration: 19/03/2010
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: An extension trial to NN1250-3579 comparing safety and efficacy of NN1250 plus OAD(s) with insulin glargine plus OAD(s) in type 2 diabetes - BEGIN™: ONCE LONG
• Scientific title: An extension trial to NN1250-3579 comparing safety and efficacy of NN1250 plus OAD(s) with insulin glargine plus OAD(s) in type 2 diabetes - BEGIN™: ONCE LONG
• Date of first enrolment: 30/04/2010
• Target sample size: 552
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015754-38
• 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

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Informed consent obtained before any 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 the main trial NN1250-3579.)
2. The subject must have completed the 52 week treatment period in trial NN1250-3579.
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 (adequate contraceptive measures as required by local law or practise [for Germany: implants, injectables, combined oral contraceptives, hormonal 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.


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

Health Condition(s) or Problem(s) studied

Type 2 diabetes
MedDRA version: 14.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

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 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
• Self measured plasma glucose for dose adjustments
• Patient Reported Outcome (PRO) Questionnaire

Main Objective: The primary objective is to investigate the long-term safety and tolerability of NN1250. This is done by comparing NN1250 to insulin glargine after 104 weeks of treatment (52 weeks of treatment in NN1250-3579 plus 52 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
• 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
• Change from baseline in insulin antibodies after 104 weeks of treatment

Secondary ID(s)

2009-015754-38-FR

NN1250-3643