A 26-week, randomised, open-label, multinational, treat-to-target trialcomparing efficacy and safety of insulin degludec/insulin aspart once daily(OD) and insulin glargine OD both in combination with metformin ininsulin-naïve subjects with type 2 diabetes inadequately controlled on oralantidiabetic drugs (OADs) - BOOST™ : START 2

• Conditions: Type 2 diabetes; MedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus

• Registration Number: EUCTR2009-017814-56-PL
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-14
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 795

Inclusion Criteria

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
• Male or female = 18 years of age
• Type 2 diabetes mellitus (diagnosed clinically) for = 6 months
• HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis
• BMI = 40.0 kg/m^2
• Insulin naïve subjects (Allowed are: Previous short term insulin treatment up to 14 days; Treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
• Ongoing treatment with: Metformin with or without other OAD for at least 3 months prior to randomisation with the minimum metformin dose of 1500 mg daily or maximum tolerated dose (at least 1000 mg daily).
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

• Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
• Use within 3 months prior to Visit 1 of GLP-1 receptor agonist and/or TZDs
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke;
decompensated heart failure New York Heart Association (NYHA)3 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified